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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00162019
Other study ID # 040201
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 31, 2003
Est. completion date August 24, 2004

Study information

Verified date April 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 IMMUNATE S/D and its predecessor IMMUNATE. Part 2 is an evaluation of efficacy and safety of IMMUNATE S/D. Part 3 is a pharmacokinetic study of IMMUNATE S/D.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 24, 2004
Est. primary completion date August 24, 2004
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)


Locations

Country Name City State
Bulgaria National Centre of Hematology and Transfusiology Sofia
Czechia University Hospital Motol Prague
Hungary National Medical Center, National Hemophilia Center Budapest
Poland Klinika Hemetologii I Onkologii Dzieciecej Warsaw
Poland Klinika Hematologii i Onkologii Dzieciecej Wroclaw

Sponsors (1)

Lead Sponsor Collaborator
Baxalta now part of Shire

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Hungary,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the PK parameters of IMMUNATE S/D and IMMUNATE in subjects with severe hemophilia A (baseline factor VIII <= 1%) Within 30 minutes pre-infusion; and at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 28 hours, 32 hours, and 48 hours post-infusion.
Primary to re-evaluate PK parameters for IMMUNATE S/D after a minimum of 14 weeks ± 7 days of treatment with at least 10 exposure days with IMMUNATE S/D Within 30 minutes pre-infusion; and at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 28 hours, 32 hours, and 48 hours post-infusion.
Primary to monitor the incidence of factor VIII inhibitor development over a minimum of 27 weeks ± 7 days or at least 50 exposure days, whichever occurs first, in all subjects Post-Infusion for a minimum of 27 weeks ±7 days or at least 50 treatment EDs, whichever occurs first.
Primary to evaluate the hemostatic efficacy of IMMUNATE S/D in the management of acute bleeding episodes and in the perioperative management of surgical prophylaxis, if required, over the same period of treatment Post-Infusion for a minimum of 27 weeks ±7 days or at least 50 treatment EDs, whichever occurs first.
Primary to assess the clinical safety of IMMUNATE S/D Throughout the study period of approximately 18 months.
Primary to retrospectively explore the PK parameters of the VWF moiety of IMMUNATE S/D in subjects with severe hemophilia A (baseline factor VIII <= 1%). Up to approximately 6.5 months
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