To compare the efficacy and safety of EUS guided combined application of thrombin and cyanoacrylate injection with EUS guided cyanoacrylate injection alone for the management of patients with gastroesophageal varices: A randomized control trial - NIL

Start Date20 Jan 2024

Sponsor / Collaborator-

CTRI/2020/07/026466 / RecruitingPhase 3IIT

ENDOSCOPIC GLUE INJECTION VS ENDOSCOPIC HUMAN THROMBIN INJECTION FOR BLEEDING GASTRIC VARICES â?? A RANDOMISED CONTROLLED TRIAL

Start Date15 Jul 2020

Sponsor / Collaborator

SMS Medical College & Hospital

NCT00859547 / CompletedPhase 4

A Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting

The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.

Start Date01 Mar 2009

Sponsor / Collaborator

ZymoGenetics, Inc.

100 Clinical Results associated with Thrombin alfa(ZymoGenetics)

100 Translational Medicine associated with Thrombin alfa(ZymoGenetics)

100 Patents (Medical) associated with Thrombin alfa(ZymoGenetics)

Literatures (Medical) associated with Thrombin alfa(ZymoGenetics)

14 Sep 2021·Journal of Investigative SurgeryQ4 · MEDICINE

A Comparative Efficacy Evaluation of Recombinant Topical Thrombin (RECOTHROM^®) With A Gelatin Sponge Carrier Versus Topical Oxidized Regenerated Cellulose (TABOTAMP^®/SURGICEL^®) In A Porcine Liver Bleeding Model

Q4 · MEDICINE

Article

Author: Slezak, Paul ; Labahn, Dirk ; Keibl, Claudia ; Genyk, Yuri ; Gulle, Heinz ; Schmidbauer, Anna

PURPOSETopical hemostatic agents can be classified as active or passive. This study compared the hemostatic efficacy of an active agent, recombinant thrombin (RECOTHROM^® [rT]) plus gelatin sponge carrier versus a passive agent, oxidized regenerated cellulose (TABOTAMP^®/SURGICEL^® [ORC]), in a porcine liver abrasion model.MATERIALS AND METHODSEight pigs were used, four of them were heparinized. A total of 80 liver lesions were created, 40 of them in heparinized pigs. Lesions were treated with rT plus gelatin sponge or ORC. Bleeding rate was quantified before treatment by applying pre-weighed gauze. Time to hemostasis was assessed visually for 10 minutes.RESULTSSeven of the 80 lesions were excluded for having initial bleeding rates exceeding the target of 10 g/min. Sixteen and 20 lesions were treated with rT plus gelatin sponge and 19 and 18 lesions were treated with ORC, in non-heparinized and heparinized animals, respectively. Time to hemostasis (median [IQR]) was significantly shorter with rT plus gelatin sponge (30 [30,30] seconds) in heparinized and non-heparinized animals versus ORC in non-heparinized (180 [120,210] seconds) and heparinized animals (215 [135,345] seconds); P < 0.0001 for both comparisons. In heparinized animals, ORC took longer to achieve hemostasis, with treatment failure in 2/18 lesions. Time to hemostasis with ORC was longer for lesions in heparinized animals with initial bleeding rates of >5-10 g/min (285 [225,394] seconds) versus ≤5 g/min (175 [108,290] seconds).CONCLUSIONSIn this model, rT plus gelatin sponge carrier (active) was a more effective hemostat than ORC (passive) in both heparinized and non-heparinized animals.

01 Jul 2019·MenopauseQ3 · MEDICINE

Topical estrogen prescribing patterns for urogenital atrophy among women with breast cancer: results of a national provider survey

Q3 · MEDICINE

Article

Author: Pollack, Craig E ; Richter, Lee A ; Lynce, Filipa C ; Willey, Shawna C ; Tefera, Eshetu ; Han, Jim ; Bradley, Sarah

AbstractObjective:The aim of the study was to evaluate knowledge, attitudes, and practice patterns of physicians prescribing topical estrogen for women with urogenital atrophy and a history of breast cancer.Methods:A cross-sectional survey of breast surgeons, urogynecologists, and gynecologists was distributed via their professional societies: the American Society of Breast Surgeons (ASBrS), the American Urogynecologic Society (AUGS), and the Society of Gynecologic Surgeons (SGS). Providers reported level of comfort prescribing vaginal estrogen for urogenital symptoms for women with different categories of breast cancer and current treatment: estrogen receptor (ER) negative, ER positive no longer on endocrine therapy, and ER positive currently on adjuvant endocrine therapy. General knowledge questions assessed agreement on a 5-point Likert scale to statements about vaginal estrogen safety and pharmacology.Results:A total of 820 physicians completed the survey: 437 responses from the ASBrS (response rate, 26.7%), 196 from AUGS (15%), and 187 from SGS (44.5%). The majority of physicians (84%), regardless of specialty, felt comfortable prescribing vaginal estrogen to women with a history of ER-negative cancer: 65.7% felt comfortable prescribing for women with ER-positive breast cancer no longer on endocrine therapy; 51.3% for women on an aromatase inhibitor; and 31.4% for women on tamoxifen. Urogynecologists were significantly more comfortable than breast surgeons prescribing vaginal estrogen for the lowest risk patients, whereas breast surgeons had the highest level of comfort for women currently on endocrine therapy.Conclusions:This study highlights heterogeneity in practice patterns both within and across specialties. The clinical variation seen in this study suggests providers may benefit from increased knowledge regarding vaginal estrogen.

01 Nov 2018·Obstetrics & GynecologyQ2 · MEDICINE

Topical Estrogen Prescription Fill Rates for Women With a History of Breast Cancer Who Are Taking Hormone Therapy

Q2 · MEDICINE

Article

Author: Amanda L. Blackford ; Craig E. Pollack ; Joseph H. Huntley ; Oluseyi Aliu ; Lee A. Richter

OBJECTIVE:To evaluate how often women with a history of breast cancer who are taking hormone therapy (HT) filled prescriptions for topical estrogens and whether this frequency varied over time and by type of HT used.METHODS:We performed a retrospective cohort study using medical and outpatient drug claims from a large commercial claims database for the years 2010–2015. Women younger than age 65 years taking HT for breast cancer were classified as users of 1) tamoxifen only, 2) aromatase inhibitor(s) only, or 3) any other or multiple HTs. Our outcome variable was filling a prescription for topical estrogen in a given year. We used multivariable logistic regression models estimated with generalized estimating equations to determine whether the fill rate varied over time and by HT category adjusting for age, receipt of surgical or radiation treatment, types of outpatient health care provider visits, and comorbidities.RESULTS:We identified 352,118 records from 176,012 unique patients (mean age 54.3 years, range 18–64 years) who met eligibility criteria. Aromatase inhibitors were used more commonly (56.0% of patient-years) than tamoxifen (38.8%). Overall, 3.0% (range 2.9–3.1%) of women filled any topical estrogen prescription in a given calendar year. More than half of filled topical estrogen prescriptions were for tablets (57.0%) with the remainder for creams (25.8%) and rings (17.3%). In adjusted analyses, the fill rate for women taking tamoxifen was significantly less (2.4%; 95% CI 2.3–2.5%) than for women taking aromatase inhibitors (3.3%; 95% CI 3.2–3.4%). There was a small but statistically significant increase in fill rates across years (odds ratio 1.03, 95% CI 1.02–1.04).CONCLUSION:A small proportion of women with a history of breast cancer who were taking HT filled a topical estrogen prescription, with significant differences by type of HT. More evidence is needed to inform national guidelines regarding safety and appropriate use of topical estrogens in this patient population.

News (Medical) associated with Thrombin alfa(ZymoGenetics)

14 Nov 2017

·www.biospace.com

eXIthera Presents Clinical Data on Novel Small Molecule FXIa Inhibitor EP-7041 at American Heart Association

Antithrombotic EP-7041 safe and well tolerated; performed in antithrombotic test range associated with clinical efficacy and with fast onset/offset of activity WESTBOROUGH, MA -- (Marketwired) -- Nov 13, 2017 -- eXIthera Pharmaceuticals, a clinical stage biotech company focused on discovering and developing effective anticoagulants/antithrombotics without increased bleeding risk or the need for a reversal agent, today announced data from a Phase 1 study of EP-7041, a potent and selective small molecule FXIa inhibitor. EP-7041 was safe and well tolerated in healthy volunteers following single or multiple ascending doses, and the pharmacokinetic (PK) and pharmacodynamic (PD) pro desired efficacy with minimal potential for bleeding. EP-7041 is a novel, potent, selective small molecule FXIa inhibitor designed to prevent thrombosis with limited risk for bleeding side effects. Results from the study were highlighted in a poster presentation on November 13 at the American Heart Association (AHA) Scientific Sessions 2017, in Anaheim, California. The double-blind study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of single or multiple ascending intravenous infusions of EP-7041 in 60 normal, healthy volunteers. EP-7041 was safe and well tolerated with no serious adverse events. Parenteral administration of EP-7041 resulted in a rapid, predictable increase in aPTT, a standard clinical measure of anticoagulation activity, without affecting PT, indicating no unwanted/unintended effect on the extrinsic pathway. Circulating levels of the drug were rapidly achieved and the levels quickly decreased on cessation of dosing, with no bleeding observed or reported. The pharmacokinetic and pharmacodynamics pro EP-7041 is ideal in acute care hospital settings where patients are at risk of thromboembolic events. "We were very pleased with the results from this study, which supports the potential for an effective antithrombotic without increased bleeding risk or the need for a reversal agent," said Neil J. Hayward, PhD, President and CEO of eXIthera. "Our complementary intravenous and oral Factor XIa inhibitors are being developed to provide safe, effective prevention of thrombosis in both hospital and out-patient settings. We expect to select our oral development candidate in the near future and are progressing toward the next stage of clinical development for EP-7041 while actively seeking partnerships for both programs." There remains a large unmet medical need for a safer antithrombotic. Currently available thrombin and Factor Xa inhibitors are effective, but there are limitations for use in certain indications, and bleeding remains an issue. Factor XIa is a clinically validated target for the prevention of thrombosis by selectively inhibiting the activation of the intrinsic pathway, without impacting normal hemostasis (bleeding) through the extrinsic pathway, yielding an antithrombotic with minimal risk of bleeding. In addition to EP-7041, eXIthera is developing an oral product candidate to facilitate smooth transition from inpatient to outpatient treatment settings. About eXIthera Pharmaceuticals Inc eXIthera Pharmaceuticals is a clinical stage biotechnology company developing novel anticoagulants/antithrombotics to be used with patients at risk of thromboembolic events. eXIthera's drugs are based on the unique pathophysiological role of Factor XI in the initiation of intravascular thrombi without causing undue bleeding. The Company is advancing two small molecule programs to inhibit Factor XIa, a clinically validated target for the prevention of thrombosis. eXIthera's lead product, EP-7041, is parentally administered and has successfully completed Phase 1a/1b clinical studies. The oral program is advancing towards formal development. The two products could facilitate a smooth transition from inpatient to outpatient treatment settings. For more information, visit . Michelle Linn 774-696-3803 linnmich@comcast.net

Small molecular drugAHA

100 Deals associated with Thrombin alfa(ZymoGenetics)

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R&D Status

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Indication	Country/Location	Organization	Date
Hemorrhage	US	ZymoGenetics, Inc.	17 Jan 2008
Hemorrhage	US	Baxter Healthcare Corp.	17 Jan 2008

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00813904 (CTgov)	Phase 4	Blood Loss, Surgical	31	rThrombin, 1000 IU/mL	zirccojcmc(rukgtmlfek) = euuktzgmlb mxcwlsqpms (easuoqlgyj, fsdoazajqe - pwyizbzszg) View more	-	08 Dec 2011
ASN2011	Not Applicable	Nephritis, Interstitial	-	Thrombin	uksnnhlwee(chohsapjmv) = wfoiytrazw wazbfxfwqq (exbmhnqnfr )	-	08 Nov 2011
Pubmed \| J Am Coll Surg	Phase 3	Blood Loss, Surgical	209	Topical recombinant thrombin	skvqvjhcnx(bypmvmkhxc) = momatevreh nqtxzaioyj (qeywcoawas )	-	01 Jul 2009

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