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A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX

Information source: rEVO Biologics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A With Inhibitors; Hemophilia B With Inhibitors

Intervention: Coagulation Factor VIIa (Recombinant) (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: rEVO Biologics

Official(s) and/or principal investigator(s):
Jean Francois Schved, MD, Principal Investigator, Affiliation: Saint Eloi Hospital

Summary

The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX

Clinical Details

Official title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bleeding episode treatment success

Secondary outcome: Time to bleeding success

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- be male with a diagnosis of congenital hemophilia A and/or B of any severity

- have one of the following:

- a positive inhibitor test Bethesda Unit (BU) ≥ 5 (as confirmed at screening by the

institutional lab), OR

- a BU<5 but expected to have a high anamnestic response to FVIII or FIX, as

demonstrated from the subject's medical history, precluding the use of Factor VIII or IX products to treat bleedings, OR

- a BU<5 but expected to be refractory to increased dosing of FVIII or FIX, as

demonstrated from the subject's medical history, precluding the use of Factor VIII or IX products to treat bleedings

- be 12 years or older, up to and including 75 years of age (NOTE: different age

restrictions may apply per local regulation and/or ethical considerations)

- have at least 3 bleeding episodes of any severity in the past 6 months be capable of

understanding and willing to comply with the conditions of the protocol

- have read, understood and provided written informed consent (patient and/or

parent(s)/legal guardian(s) if <18 years of age) Exclusion Criteria:

- have any coagulation disorder other than hemophilia A or B

- be immuno-suppressed (i. e., the patient should not be receiving systemic

immunosuppressive medication, cluster of differentiation 4 (CD4) counts at screening should be >200/µl)

- have a known allergy or hypersensitivity to rabbits

- have platelet count <100,000/mL

- have had within one month prior to first administration of the study drug in this

study a major surgical procedure (e. g. orthopedic, abdominal)

- have received an investigational drug within 30 days of the first study drug

administration, or is expected to receive such drug during participation in this study

- have a clinically relevant hepatic (AST and/or alanine aminotransferase (ALT) >3

times the upper limit of normal) and/or renal impairment (creatinine >2 times the upper limit of normal)

- have a history of arterial and/or venous thromboembolic events (such as myocardial

infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, or current New

York Heart Association (NYHA) functional classification score of stage II - IV

- have an active malignancy (those with non-melanoma skin cancer are allowed)

- have any life-threatening disease or other disease or condition which, according to

the investigator's judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome (e. g., a history of non-responsiveness to bypassing products).

Locations and Contacts

Republican Research Center for Radiation Medicine and Human Ecology, Gomel, Belarus

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Bulgaria

LTD HEMA, Tbilisi, Georgia

Chaim Sheba Medical Center, Tel-hashomer hospital, Ramat Gan 5261, Israel

Institute of Hematology and Transfusion Medicine, Warsaw, Poland

Kirov Research Institute of Hematology and Blood Transfusion, Kirov, Russian Federation

Hematology Research Center, Moscow, Russian Federation

City Outpatient Clinic #37, Saint-Petersburg, Russian Federation

Kyiv City Clinical Hospital #9, Kyiv, Ukraine

Institute of Blood Pathology and Transfusion Medicine of Academy of Medical Sciences of Ukraine, Lviv, Ukraine

Basingstoke and North Hampshire Hospital, Hemophilia, Hemostasis and Thrombosis Center, Basingstoke, Hampshire, RG24 9NA,, United Kingdom

Orthopaedic Hemophilia Treatment Center, Los Angeles, California 90007, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California 95817, United States

University of Colorado Hemophilia and Thrombosis Center, Aurora, Colorado 80045, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

University of Minnesota Medical Center Fairview, Minneapolis, Minnesota 55455, United States

Additional Information

Starting date: April 2014
Last updated: June 10, 2015

Page last updated: August 23, 2015

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