Delving into the Latest Updates on CSL Behring KK with Synapse

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Hemic and Lymphatic Diseases

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A retrospective chart review study of recombinant factor IX albutrepenonacog alfa treatment in previously untreated pediatric patients with hemophilia B in Japan - A retrospective chart review study of recombinant factor IX albutrepenonacog alfa treatment in previously untreated pediatric patients with hemophilia B in Japan

Start Date01 May 2024

Sponsor / Collaborator

CSL Behring KK

JPRN-UMIN000054086 / Suspended

The humanistic burden of hereditary angioedema (HAE): a patient survey in Japan - The humanistic burden of hereditary angioedema (HAE): a patient survey in Japan

Start Date10 Apr 2024

Sponsor / Collaborator

CSL Behring KK

JPRN-UMIN000047418 / Completed

The clinical impact of immunoglobulin replacement therapy on severe bacterial infection for patients with hypogammaglobulinemia secondary to hematologic malignancies: A Japanese claims database study - A database study on immunoglobulin replacement therapy in patients with secondary hypogammaglobulinemia

Start Date31 May 2022

Sponsor / Collaborator

CSL Behring KK

100 Clinical Results associated with CSL Behring KK

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0 Patents (Medical) associated with CSL Behring KK

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2

Literatures (Medical) associated with CSL Behring KK

01 Jan 2019·Japanese Journal of Thrombosis and Hemostasis

Sub analysis of Japanese patients with hemophilia A in rVIII-SingleChain clinical trial

Author: YAMAMOTO, Koji ; KUWAHARA, Mitsuhiro ; NAGAO, Azusa ; SATO, Naohito ; FUJIWARA, Mitsuhiro ; FUKUTAKE, Katsuyuki ; HIGASA, Satoshi ; WAKI, Kenji ; KOH, Katsuyoshi ; SUZUKI, Nobuaki ; SHIMA, Midori ; NOGAMI, Keiji ; MATSUSHITA, Tadashi ; KOBAYASHI, Midori ; SATO, Tetsuji

RVIII-SingleChain is a novel B-domain-truncated recombinant factor VIII, comprised of covalently bonded factor VIII (FVIII) heavy and light chains.This phase 1/3 open-label, nonrandomized multicenter pivotal study investigated the safety, efficacy and pharmacokinetics (PK) of rVIII-SingleChain in previously treated patients with severe hemophilia A.Study participants were males with severe hemophilia A (FVIII activity <1%), with >150 exposure days [EDs] to FVIII prior to enrollment, aged between 12 and 65 years. rVIII-SingleChain was administered 20 to 40 IU/kg every second day or 20 to 50 IU/kg, 2 to 3 times per wk, or with other dosing regimens at the investigator's discretion.Ten of the 174 subjects recruited were Japanese.In all subjects, the median annualized spontaneous bleeding rate (AsBR) of total prophylaxis therapy was 0.0 and the median annualized bleeding rate (ABR) was 1.14, whereas the median AsBR of on-demand therapy was 11.73 and the median ABR was 19.64.In Japanese subjects, the median AsBR of prophylaxis was 0.00, and the median ABR was 0.00, whereas the median AsBR of on-demand therapy was 3.55, the median ABR was 6.22.No patient developed an inhibitor, and no safety concerns were identified in the study.

01 Jan 2017·Japanese Journal of Thrombosis and Hemostasis

Sub analysis of Japanese patients with hemophilia B in rIX-FP clinical trial

Author: AMANO, Kagehiro ; SHIMA, Midori ; NOGAMI, Keiji ; KOBAYASHI, Midori ; FUJII, Teruhisa ; FUKUTAKE, Katsuyuki ; YAMAMOTO, Koji ; MATSUSHITA, Tadashi ; HANABUSA, Hideji ; HIGASA, Satoshi ; NAGAO, Azusa ; KUWAHARA, Mitsuhiro ; TAKI, Masashi ; SAKAI, Michio ; JISIN, Yang

A recombinant coagulation factor IX albumin fusion protein (rIX-FP, CSL654) was developed with an improved PK profile to support a longer dosing interval for routine prophylaxis treatment.Japanese subjects have participated in a Study CSL654_3001, phase 3 open label, multinational, pivotal study of rIX-FP.Male hemophilia B patients with no inhibitor, 12-65 years of age, at least 150 exposure days with previous FIX products were eligible for enrollment. 10 of the 63 Study 3001 subjects were recruited in Japan.The mean t1/2 of rIX-FP in Japanese and all subjects were 95 h and 102 h resp.The mean annualized spontaneous bleeding rate in Japanese and all subjects were 12.8 and 14.6 resp. for on-demand treatment, 1.8 and 0.6 resp. for weekly prophylaxis regimen, 0.4 and 1.1 resp. for every 2 wk prophylaxis regimen.No patient developed an inhibitor and no safety concerns were identified in Study 3001.The results of Japanese subjects were consistent with those observed for the global population. rIX-FP is safe and effective for preventing bleeding episodes at weekly and every 2 wk dosing regimens in Japanese patients with hemophilia B.

100 Deals associated with CSL Behring KK

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100 Translational Medicine associated with CSL Behring KK

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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