[Translation] A prospective, multicenter, open-label Phase III study to evaluate the efficacy, safety, and pharmacokinetics of recombinant human coagulation factor VIII for injection (ADYNOVATE) in the prevention and treatment of bleeding in previously treated Chinese patients with severe hemophilia A (FVIII <1%)

主要目的：根据总ABR评估ADYNOVATE用于预防性治疗中国重度A型血友病受试者的有效性。次要目的：基于出血部位的ABR和病因，评估ADYNOVATE用于预防性治疗的有效性评估ADYNOVATE用于治疗研究期间非手术突破性出血事件的总体止血有效性评估ADYNOVATE用于围手术期出血管理（如果在研究期间进行小手术）的有效性通过评估AE、严重AE（SAE）以及具有临床意义的生命体征和临床实验室参数结果来评价ADYNOVATE的安全性根据产生FVIII抑制性抗体和ADYNOVATE结合抗体的发生率评价ADYNOVATE的安全性和免疫原性评价ADYNOVATE在中国受试者中的PK

[Translation]

Primary Objectives: To evaluate the effectiveness of ADYNOVATE for prophylactic treatment of Chinese subjects with severe hemophilia A based on total ABR. Secondary Objectives: To evaluate the effectiveness of ADYNOVATE for prophylactic treatment based on ABR and etiology of bleeding site To evaluate the overall hemostatic effectiveness of ADYNOVATE for the treatment of non-surgical breakthrough bleeding events during the study period To evaluate the effectiveness of ADYNOVATE for perioperative bleeding management (if minor surgery is performed during the study period) To evaluate the safety of ADYNOVATE by evaluating AEs, serious AEs (SAEs), and clinically significant results of vital signs and clinical laboratory parameters To evaluate the safety and immunogenicity of ADYNOVATE based on the incidence of FVIII inhibitory antibodies and ADYNOVATE binding antibodies To evaluate the PK of ADYNOVATE in Chinese subjects

Start Date27 Mar 2023

Sponsor / Collaborator

Baxalta Manufacturing SARL

[+2]

NCT05707351 / Active, not recruitingPhase 3

A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%)

The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically.
Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

Start Date27 Mar 2023

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT05042440 / CompletedPhase 1

A Phase 1, Single-Site, Open-Label Study to Assess Pharmacokinetics of Efanesoctocog Alfa (BIVV001), Standard Half-Life and Extended Half-Life FVIII After Each Single Intravenous Injection in a Fixed Sequence, in Previously Treated Adults With Severe Hemophilia A

Primary objective
• To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection
Secondary objectives
To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection
To evaluate the safety and tolerability of a single IV injection of BIVV001

Start Date11 Aug 2021

Sponsor / Collaborator

Sanofi SA

100 Clinical Results associated with Rurioctocog alfa pegol

100 Translational Medicine associated with Rurioctocog alfa pegol

100 Patents (Medical) associated with Rurioctocog alfa pegol

Literatures (Medical) associated with Rurioctocog alfa pegol

01 Jan 2024·Journal of thrombosis and haemostasis : JTH

Evaluation of collagen turnover biomarkers as an objective measure for efficacy of treatment with rurioctocog alfa pegol in patients with hemophilia A: a secondary analysis of a randomized controlled trial

Article

Author: Engl, Werner ; Escobar, Miguel ; Windyga, Jerzy ; Karsdal, Morten ; Manon-Jensen, Tina ; Bager, Cecilie ; von Drygalski, Annette ; Chowdary, Pratima ; Tangada, Srilatha ; Frederiksen, Peder ; Klamroth, Robert ; Ewenstein, Bruce

BACKGROUND:

Patients with hemophilia who have recurrent hemarthroses develop hemophilic arthropathy (HA). Regular prophylaxis with factor (F) VIII (FVIII) can reduce HA, but there is a need for objective outcome measures to evaluate treatment efficacy.

OBJECTIVES:

Evaluate and assess collagen turnover biomarkers in patients with hemophilia A to determine the efficacy of rurioctocog alfa pegol treatment and understand their potential as tools for guiding treatment decisions and monitoring outcomes.

METHODS:

Joint remodeling was assessed by analyzing serum levels of collagen remodeling products at baseline and months 3, 6, 9, and 12 in a 98 patient subset receiving pharmacokinetics-guided prophylaxis with rurioctocog alfa pegol, targeting FVIII trough levels of 1 to 3 International Units (IU)/dL or 8 to 12 IU/dL (PROPEL study, NCT0285960).

RESULTS:

Basement membrane metabolism-related type 4 collagen remodeling products (C4M and PRO-C4) decreased after 3 months at all time points by up to 25% at 1 to 3 IU/dL (P = .049, P < .0001) and 8 to 12 IU/dL FVIII trough levels (P = .0002, P < .0001). Interstitial tissue metabolism-related type 3 (C3M) and 5 (PRO-C5) collagen remodeling products decreased after 3 months, by up to 19% at 1 to 3 IU/dL FVIII trough level (P = .0001, P = .009) and 23% at 8 to 12 IU/dL FVIII trough level (P = .0002, P = .001). An increase of up to 12% was seen for cartilage metabolism-related type 2 collagen product (PRO-C2, not C2M) after 6 months at both trough levels (P = .01, P = .005). When stratified by prior treatment, changes in C3M (P = .03) and C4M (P = .02) levels were observed between trough levels for prior on-demand treatment but not for prophylaxis prior to study entry.

CONCLUSION:

Joint improvement measured by collagen remodeling biomarkers specific to the basement membrane, interstitial matrix, and cartilage was seen with pharmacokinetics-guided prophylaxis. These collagen remodeling biomarkers warrant further exploration as biomarkers to guide treatment toward improvement in HA.

31 Dec 2023·Journal of medical economics

Healthcare costs among hemophilia A patients in the United States treated with rurioctocog alfa pegol (FVIII-PEG) or antihemophilic factor (recombinant), FC fusion protein (rFVIIIFc) using real-world data

Article

Author: Princic, Nicole ; Farahbakhshian, Sepehr ; Schultz, Bob G ; Park, Julie ; Bullano, Michael ; Fan, Qi

AIMS:

To compare healthcare costs in patients with non-inhibitor hemophilia A treated with Rurioctocog Alfa Pegol (FVIII-PEG) versus Antihemophilic Factor (Recombinant), FC Fusion Protein (rFVIIIFc).

MATERIALS AND METHODS:

Administrative claims data from the Merative MarketScan Commercial (Commerical) and Medicaid (Medicaid) databases were used for these analyses. Males with non-inhibitor hemophilia A treated with FVIII-PEG or rFVIIIFc from 1 January 2016 to 31 March 2021 were identified (earliest treatment = index). Patients were required to have continuous database enrollment for six months before and after the index date. Follow-up was variable in length until disenrollment or study end. All-cause and hemophilia-related healthcare costs were reported per-patient per month [PPPM] and the average weekly dose during follow-up was compared between treatment groups. Generalized linear regressions were used to estimate multivariable-adjusted differences in total costs and weekly dosage in the two treatment groups.

RESULTS:

A total of 131 FVIII-PEG (66 Commercial; 65 Medicaid) and 204 rFVIIIFc (111 Commercial; 93 Medicaid) patients were eligible. Mean age was 20.5 and 24.4 for FVIII-PEG and rFVIIIFc in Commercial and 14.9 and 17.5 for FVIII-PEG and rFVIIIFc in Medicaid. PPPM mean (standard deviations [SD]) total healthcare costs in Commercially insured patients were $35,868 [$21,717] for FVIII-PEG vs $40,424 [$25,882] for rFVIIIFc. Costs in Medicaid were $27,495 [$23,243] for FVIII-PEG vs $30,237 [$28,430] for rFVIIIFc. After adjusting for baseline characteristics, the costs for rFVIIIFc (vs FVIII-PEG) were higher by $5,215 in Commercial and $3,895 in Medicaid, but the differences were not statistically significant (p > 0.05). Similar findings were observed for hemophilia-specific healthcare costs. The adjusted mean weekly dose was 6,047 vs 4,892 IU, p = 0.21 for FVIII-PEG vs rFVIIIFc in Commercial and 5,549 vs 7,228 IU, p = 0.07 for FVIII-PEG vs rFVIIIFc in Medicaid.

CONCLUSIONS:

Healthcare costs and treatment dosing were similar (p > 0.05) for non-inhibitor hemophilia A patients treated with FVIII-PEG and rFVIIIFc.

01 Nov 2023·European journal of haematology

Clinical efficacy of simoctocog alfa versus extended half‐life recombinant FVIII concentrates in hemophilia A patients undergoing personalized prophylaxis using a matching‐adjusted indirect comparison method

Article

Author: Corrales-Medina, Fernando F ; Kessler, Craig M ; Tarantino, Michael D ; Jiménez-Yuste, Víctor ; Mannucci, Pier Mannuccio

Abstract:

Objectives:

We aimed to indirectly compare the efficacy of personalized prophylaxis with simoctocog alfa (Nuwiq®) versus three extended half‐life (EHL) recombinant FVIII (rFVIII) concentrates.

Methods:

Treatment effects were compared using matching‐adjusted indirect comparisons after matching individual patient‐level baseline characteristics for simoctocog alfa (pharmacokinetic [PK]‐guided personalized prophylaxis) against published aggregate personalized prophylaxis data for efmoroctocog alfa, damoctocog alfa pegol, and rurioctocog alfa pegol.

Results:

A higher percentage (p < .001) of patients with zero bleeds was found with simoctocog alfa compared with efmoroctocog alfa (75% vs. 45%), damoctocog alfa pegol (77% vs. 38%), and rurioctocog alfa pegol (target trough level 1%–3%; 78% vs. 42%). Similar efficacy was found comparing simoctocog alfa against rurioctocog alfa pegol 8%–12% (77% vs. 62%). The mean total annualized bleeding rate was lower (p < .001) with simoctocog alfa than damoctocog alfa pegol (1.5 vs. 4.9). Consistent with approved dosing, the mean FVIII weekly dose was higher (p < .001) for simoctocog alfa than efmoroctocog alfa, damoctocog alfa pegol, or rurioctocog alfa pegol 1%–3%, but lower (p < .001) than rurioctocog alfa pegol 8%–12%.

Conclusions:

Indirect comparisons demonstrated that PK‐guided, personalized prophylaxis with simoctocog alfa can lead to higher zero bleed rates compared with personalized EHL rFVIII concentrate regimens, albeit with higher weekly doses, and a lower percentage of patients treated twice weekly or less.

News (Medical) associated with Rurioctocog alfa pegol

31 Oct 2023

·www.prnewswire.com

Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products

The well-established matching-adjusted indirect comparison (MAIC) methodology was used to compare the efficacy of personalised prophylaxis with Nuwiq® against other recombinant FVIII products Personalised prophylaxis with Nuwiq® can lead to higher rates of patients with zero bleeds compared with other recombinant FVIII products, albeit with higher weekly doses The data were published recently in the European Journal of Haematology LACHEN, Switzerland, Oct. 31, 2023 /PRNewswire/ -- Data from a matching-adjusted indirect comparison (MAIC) of Nuwiq® (simoctocog alfa) versus extended half-life recombinant factor VIII (rFVIII) concentrates in haemophilia A patients undergoing personalised prophylaxis were published in the European Journal of Haematology1. Preliminary data from the MAIC were presented by Dr Craig Kessler, Lombardi Comprehensive Cancer Center and Georgetown University Medical Center, at the 65th ASH Annual Meeting & Exposition in December 20222. Continue Reading Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products The analysis used MAIC – a well-established statistical approach – to compare the efficacy of pharmacokinetic (PK)-guided, personalised prophylaxis with Nuwiq® (simoctocog alfa) versus Eloctate® (efmoroctocog alfa), Jivi® (damoctocog alfa pegol), and Adynovate® (rurioctocog alfa pegol). The analysis used data from prospective clinical trials of personalised prophylaxis in adults with severe haemophilia A. Dr Kessler commented, "This MAIC exercise provides important comparative data on the efficacy and consumption of various recombinant FVIII products in adults with haemophilia A on personalised prophylaxis. The results can be considered by clinicians and patients when treatment decisions are being made." MAICs are a way of comparing the efficacy of different medical interventions or products in the absence of head-to-head randomised trials3. By matching patient populations based on clinically relevant baseline characteristics, it reduces inherent differences between the studies and can provide comparative evidence of relative treatment effects. Individual patient data from patients treated with Nuwiq® in the NuPreviq study were compared with aggregated data from 117 patients treated with Eloctate® in the personalised prophylaxis arm of the A-LONG study, 110 patients treated with Jivi® in the PROTECT VIII study, and patients treated with Adynovate® in the PROPEL study (which had two arms targeting different FVIII trough levels: 1–3% (57 patients) and 8–12% (58 patients)). A significantly higher percentage of patients with zero bleeds was reported with Nuwiq® compared with Eloctate® (75% vs 45%), Jivi® (77% vs 38%) or Adynovate® (target trough level 1–3%; 78% vs 42%). The efficacy of Nuwiq® was similar to that of Adynovate® in the 8–12% arm (77% vs 62%). The mean annualised bleeding rate was significantly lower with Nuwiq® than with Jivi® (1.5 vs 4.9). Consistent with the approved dosing, the mean FVIII weekly dose was significantly higher for Nuwiq® than Eloctate®, Jivi® or Adynovate® 1–3%, but lower than for Adynovate® 8–12%. Further details of the study can be found in the European Journal of Haematology publication. In addition, a short video summarising the results is available in the online version of the article. About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein4. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor4. Nuwiq® treatment has been assessed in nine4-6 completed clinical trials which included 201 previously treated patients (190 individuals)4 and 108 previously untreated patients5 with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations7. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups7. References Kessler CM et al. Eur J Haematol 2023; 111:757–67. Kessler CM and Tiede A. Blood 2022; 140(Suppl. 1): 2755–6. Signorovitch JE et al. Value Health 2012; 15:940–7. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. Liesner RJ et al. Thromb Haemost 2021; 121:1400–8. Octapharma AG, data on file. Nuwiq® Summary of Product Characteristics. Logo - Video - SOURCE Octapharma AG

Clinical ResultDrug ApprovalClinical Study

18 Oct 2022

·www.biospace.com

ADARx Pharmaceuticals Further Expands Leadership Team, Appointing Feriandas Greblikas, M.D. as VP of Clinical Development

SAN DIEGO--(BUSINESS WIRE)-- ADARx Pharmaceuticals, Inc., a biotechnology company developing RNA-targeting therapeutics, today announced the further expansion of their leadership team and clinical development capabilities through the appointment of Feriandas Greblikas, M.D. as Vice President of Clinical Development. “We are very excited to have Feriandas join the ADARx team,” said Dr. Zhen Li, President and Chief Executive officer of ADARx. “With his wealth of experience in drug development and clinical execution, he will make significant contributions to ADARx’s strategy, and operational effectiveness as we continue to advance programs to the clinic.” Dr. Greblikas joins ADARx as ADX-324 for the treatment of hereditary angioedema is set to start phase I clinical trials later this year and two additional drug candidates are expected to enter clinical trials next year. Dr. Greblikas is an established physician-scientist with more than 10 years of extensive experience in drug development, medical oversight, clinical trial planning and execution. Prior to joining ADARx, Dr. Greblikas served as a Senior Medical Director at Travere Therapeutics, in which he contributed to the development of pegtibatinase and fosmetpantothenate programs. Prior positions include Medical Director at BioMarin, Baxter and Biogen, and significant contributions to approved drugs Palynziq®, Adynovate® and Eloctate®. Dr. Greblikas received his M.D. in pediatrics from the Vilnius University. Dr. Greblikas also holds an Economics diploma from the International Business School of Vilnius University. “I am delighted to join the passionate team at ADARx and be part of a shared commitment of bringing safe and effective treatments to patients with unmet needs,” said Dr. Greblikas. “The ADARx pipeline presents diverse options for first-in-class and best-in-class drugs to realize this commitment.” About ADARx ADARx Pharmaceuticals, Inc., located in San Diego, is a biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx is developing a proprietary RNA targeting platform, including oligonucleotides for inhibition, degradation, and editing, together with novel oligonucleotide delivery technologies. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated and central nervous system diseases. ADARx lead programs are entering clinical stage.

First in ClassOligonucleotide

05 Feb 2013

·www.biospace.com

Nektar Therapeutics (CA) Announces Initiation of Investigator-Initiated Trial Evaluating Etirinotecan Pegol (NKTR-102) as a Third-Line Treatment in Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC)

SAN FRANCISCO, Feb. 5, 2013 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today the start of a Phase 2 investigator-initiated study of etirinotecan pegol in patients with metastatic and recurrent NSCLC. The study is being conducted at the Abramson Cancer Center of the University of Pennsylvania under the direction of Charu Aggarwal, M.D., M.P.H., Assistant Professor of Oncology and Corey Langer, M.D., Professor of Oncology. "Patients with metastatic or recurrent non-small cell lung cancer currently have no standard treatment options after failure of second-line treatment," said Dr. Aggarwal. "In Phase 1 studies, etirinotecan pegol demonstrated encouraging anti-tumor activity in a broad range of solid tumors including non-small cell lung cancer. We are highly interested in evaluating etirinotecan pegol as a potential treatment option for this patient population." The primary endpoint of the Phase 2 study is overall response rate (ORR). Secondary endpoints include progression free survival (PFS), overall survival (OS), median duration of response (DoR) and the safety pro etirinotecan pegol in patients with NSCLC after failure of second-line therapy. The open label, single-arm trial is expected to enroll approximately 37 patients who will receive etirinotecan pegol once every three weeks as monotherapy. "We are very pleased that Dr. Aggarwal and Dr. Langer have identified and proposed this study of single-agent etirinotecan pegol in patients with this difficult to treat cancer," said Robert Medve, M.D., Senior Vice President and Chief Medical Officer of Nektar Therapeutics. "We are pleased that there has been so much interest in etirinotecan pegol from the oncology community. The results of these studies will provide us with a greater understanding of the potential of etirinotecan pegol to benefit patients in need of new treatment options." About NSCLC Lung cancer is the leading cause of cancer-related mortality in the US with NSCLC accounting for approximately 85% of all lung cancer diagnoses [1]. Most NSCLC patients present with loco-regionally advanced or metastatic disease. Platinum-based chemotherapy is the mainstay of treatment for NSCLC in the first-line setting for metastatic disease. Even after response to first-line therapy, patients eventually develop progressive disease and require additional treatment. Currently, pemetrexed, docetaxel, and erlotinib are the only FDA approved agents in the second line setting. Erlotinib is the only agent approved for use in the third-line setting, however, progression-free survival and overall survival remain suboptimal and there are no cytotoxics formally approved to treat patients in the third-line setting. Consequently, there is a need for new therapies that are safe and effective, which may improve overall survival and quality of life. About Etirinotecan Pegol Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance anti-tumor activity. The BEACON study is a Phase 3 clinical study currently evaluating etirinotecan pegol for the treatment of locally recurrent or metastatic breast cancer. In addition to metastatic breast cancer, etirinotecan pegol is also being evaluated for the treatment of ovarian, colorectal and glioma cancers. About Nektar Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian and colorectal cancers. Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including Affymax's OMONTYS® for anemia, UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at . Nektar Investor Inquiries: Jennifer Ruddock/Nektar Therapeutics(415) 482-5585 Susan Noonan/SA Noonan Communications, LLC(212) 966-3650 Nektar Media Inquiries: Amanda Connolly/MSL (404) 870-6865 Mike Huckman /MSL (646) 500-7631 1. Siegel, R., D. Naishadham, and A. Jemal, Cancer statistics, 2012. CA Cancer J Clin, 2012. 62(1): p. 10-29. SOURCE Nektar Therapeutics

Collaborate

100 Deals associated with Rurioctocog alfa pegol

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rurioctocog alfa pegol	B02BD02	DB16007

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Coagulation Protein Disorders	JP	Takeda Pharmaceutical Co., Ltd.	05 Dec 2017
Hemophilia A	US	Takeda Pharmaceuticals U.S.A., Inc.	13 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 3	CN	Takeda (China) International Trading Co. Ltd.	27 Mar 2023
Advanced Malignant Solid Neoplasm	Phase 3	CN	Baxalta US, Inc.	27 Mar 2023
Hemorrhage	Phase 3	US	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	JP	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	AU	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	AT	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	BG	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	CZ	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	DE	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	HK	Baxalta, Inc.	15 Oct 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024)	Phase 1	Hemophilia A FVIII	-	Octocog alfa	hovfcynosb(ylgurjuafz) = 3 treatment-emergent adverse events (TEAEs) while receiving efanesoctocog alfa in 1 patient (2 mild and 1 moderate) and none reported for other treatments. No TEAEs were serious, led to treatment discontinuation, or were deemed related to efanesoctocog alfa treatment. blcbzyvqrl (udofoypxok )	Positive	14 May 2024
				Rurioctocog alfa pegol
NCT02615691 (Pubmed)	Phase 3	Hemophilia A	80	Rurioctocog alfa pegol prophylaxis	cvshnahkmq(hxdaqqpncn) = Thirteen patients experienced 14 treatment-related adverse events, including 10 cases of FVIII inhibitor development pscdvahewg (guqvrndayf )	-	03 Oct 2023
EHA2023	Not Applicable	Hemophilia B \| Hemophilia A	53	EHL-FVIII factor concentrates	kdhsmwvqoi(gvyqvogvuq) = lxqyxhqsmg plxngxluxn (eqcjiwpryc ) View more	-	08 Jun 2023
				EHL-FIX factor concentrates	kdhsmwvqoi(gvyqvogvuq) = xfmndeuahl plxngxluxn (eqcjiwpryc ) View more
ISTH2020	Not Applicable	rurioctocog alfa pegol	-	Adynovi®	ltiqnlmfgq(fmnhaofzwf) = kynqexvhnb eclawqovbo (jgephsgxar )	-	12 Jul 2020
				100% Adynovi®	ltiqnlmfgq(fmnhaofzwf) = jzovjmewqr eclawqovbo (jgephsgxar )
NCT01736475 (PROLONG-ATE, Pubmed) Manual	Phase 2/3	Hemophilia A	10	rurioctocog alfa pegol	jhfyavxmip(dlqorbtrzq) = nfpqeywqjq ltwrvrqwiu (ssuphzznzl )	Positive	01 Sep 2019
NCT02585960 (CTgov)	Phase 3	Hemophilia A	135	BAX 855 (BAX 855-Low Level)	ihygvjbqwq(xgfczdggek) = cwgadwosti dyksqxygyn (zumfgwqrkm, apoaupigog - wjflaoetvc) View more	-	26 Aug 2019
				BAX 855 (BAX 855-High Level)	ihygvjbqwq(xgfczdggek) = mapdmfetpd dyksqxygyn (zumfgwqrkm, dzknjwpkrh - kqeqrveafg) View more
ISTH2019	Phase 3	Hemophilia A	216	SHP660 prophylaxis	otwmbnrjey(bwbkymdjjt) = ahqdfznubw acbyszqton (bwwmcurqvc ) View more	-	10 Jun 2019
ISTH2019	Phase 3	Hemophilia A	216	Rurioctocog alfa pegol	xzmgbpawyr(gcdkpjflct) = a non-serious mild AE that resolved ~3-4 weeks after study end cerngnflca (hvqobuwdql )	-	10 Jun 2019
ISTH2019	Not Applicable	Hemophilia A	12	Rurioctocog alfa pegol	jmgjdytmct(aowfkjzehh) = wvkjgncwjc xdqolubaar (jeumiwkskt )	-	10 Jun 2019
NCT01945593 (CTgov)	Phase 3	Hemorrhage \| Hemophilia A	218	BAX 855 (BAX 855: Age < 2 Years)	hdypbhgdng(ajlcdbymzg) = cwqufavyvo vypvzxrhwe (ishqftqmgi, xyijobiseg - fpnrqumozp) View more	-	01 May 2019
				BAX 855 (BAX 855: Age >= 2 to <12 Years)	hdypbhgdng(ajlcdbymzg) = mdurcliuka vypvzxrhwe (ishqftqmgi, bodeurfmcw - eipzigogeo) View more

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