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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00162019
First received: September 8, 2005
Last updated: April 21, 2008
Last verified: April 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

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

Enrollment: 56
Study Start Date: March 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162019

Locations
Bulgaria
National Centre of Hematology and Transfusiology
Sofia, Bulgaria, 1756
Czech Republic
University Hospital Motol
Prague, Czech Republic, 150 06
Hungary
National Medical Center, National Hemophilia Center
Budapest, Hungary, 1135
Poland
Klinika Hemetologii I Onkologii Dzieciecej
Warsaw, Poland, 00-5 76
Klinika Hematologii i Onkologii Dzieciecej
Wroclaw, Poland, 50-345
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
  More Information

No publications provided

Responsible Party: Brigitt Abbühl, MD, Baxter
ClinicalTrials.gov Identifier: NCT00162019     History of Changes
Other Study ID Numbers: 040201
Study First Received: September 8, 2005
Last Updated: April 21, 2008
Health Authority: Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Poland: Ministry of Health

Keywords provided by Baxter Healthcare Corporation:
Factor VIII Deficiency

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014