Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients

Brief Title

Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients

Official Title

Phase 3, Prospective, Multicenter Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Efficacy of IMMUNATE Solvent Detergent (IMMUNATE SD) in Previously Treated Patients With Severe or Moderately Severe Hemophilia A

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 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

To compare the PK parameters of IMMUNATE S/D and IMMUNATE in subjects with severe hemophilia A (baseline factor VIII <= 1%)

Condition

Hemophilia A

Intervention

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 31, 2003

Completion Date

August 24, 2004

Primary Completion Date

August 24, 2004

Eligibility Criteria

        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

Gender

Male

Ages

12 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Study Director, ,

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations

NCT ID

NCT00162019

Organization ID

Responsible Party

Sponsor

Study Sponsor

Baxalta now part of Shire

Study Sponsor

Study Director, Study Director, Takeda

Verification Date

April 2021