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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162019
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 23, 2017
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : March 2003
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Primary Outcome Measures :
  1. To compare the PK parameters of IMMUNATE S/D and IMMUNATE in subjects with severe hemophilia A (baseline factor VIII <= 1%)
  2. 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
  3. 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
  4. 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
  5. to assess the clinical safety of IMMUNATE S/D
  6. to retrospectively explore the PK parameters of the VWF moiety of IMMUNATE S/D in subjects with severe hemophilia A (baseline factor VIII <= 1%).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162019

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National Centre of Hematology and Transfusiology
Sofia, Bulgaria, 1756
University Hospital Motol
Prague, Czechia, 150 06
National Medical Center, National Hemophilia Center
Budapest, Hungary, 1135
Klinika Hemetologii I Onkologii Dzieciecej
Warsaw, Poland, 00-5 76
Klinika Hematologii i Onkologii Dzieciecej
Wroclaw, Poland, 50-345
Sponsors and Collaborators
Baxalta now part of Shire
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Principal Investigator: Baxter BioScience Investigator Baxter BioScience
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Responsible Party: Brigitt Abbühl, MD, Baxter Identifier: NCT00162019    
Other Study ID Numbers: 040201
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: April 2008
Keywords provided by Shire:
Factor VIII Deficiency
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII