Status:
COMPLETED
Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether IMMUNATE S/D is effective and safe in the treatment of hemophilia A patients. The study consists of 3 parts: Part 1 is a pharmacokinetic comparison of ...
Eligibility Criteria
Inclusion
- \- Plasma factor VIII level as follows: for Parts 1 \& 3: Subjects with severe hemophilia A (plasma baseline factor VIII level \<= 1% measured at time of screening) for Part 2: Subjects with severe (plasma baseline factor VIII level \<= 1% measured at time of screening) or moderately severe hemophilia A (plasma baseline factor VIII level \<= 2% measured at time of screening)
- Males \>= 12 but \<= 65 years of age
- \>= 35 kg body weight
- Previously treated with factor VIII concentrate(s) for a minimum of 150 exposure days (as documented in the subject's medical history)
- Evidence of a protective titer to HAV and HBV at the time of screening
- Immunocompetent as defined by a CD4+ lymphocyte count \>400/mm3 and an absolute neutrophil count (ANC) \>1500
- Signed informed consent obtained from subject or legally authorized representative
Exclusion
- Documented history of inhibitor to factor VIII with a titer \>= 0.8 BU
- Current evidence of inhibitor to factor VIII with a titer \>= 0.8 BU, measured at the time of screening
- Abnormal renal function (serum creatinine \> 1.5 mg/dL)
- HIV-seropositive individuals with any of the following at the time of screening:
- CD4+ lymphocyte count \>400/mm3
- AIDS-related complex
- symptomatic AIDS Note: HIV-seropositive subjects with an absolute CD4+ lymphocyte count \> 400/mm3 are eligible to participate. HIV-seropositive subjects receiving highly active anti-retroviral therapy (HAART) regimens are eligible for enrollment if they are not excluded by the above criteria
- Active hepatic disease (ALT and AST levels \> 5 times the upper limit of normal)
- Clinical or laboratory evidence of hepatic cirrhosis including (but not limited to) a recent and persistent INR (international normalized ratio) \> 1.4, the presence of splenomegaly and/or significant spider angiomata on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices
- Known hypersensitivity to IMMUNATE
- The subject is currently participating in another investigational drug study, or has participated in any clinical study involving an investigational drug within 30 days of study entry
- The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids at a dose greater than 10 mg/day)
- The subject is identified by the investigator as being unable or unwilling to perform study procedures
Key Trial Info
Start Date :
March 31 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2004
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00162019
Start Date
March 31 2003
End Date
August 24 2004
Last Update
April 29 2021
Active Locations (5)
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1
National Centre of Hematology and Transfusiology
Sofia, Bulgaria, 1756
2
University Hospital Motol
Prague, Czechia, 150 06
3
National Medical Center, National Hemophilia Center
Budapest, Hungary, 1135
4
Klinika Hemetologii I Onkologii Dzieciecej
Warsaw, Poland, 00-5 76