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

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

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

Phase: Phase 3

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, Principal Investigator, Affiliation: Baxter BioScience

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

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%).

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Male.

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

Locations and Contacts

National Centre of Hematology and Transfusiology, Sofia 1756, Bulgaria

University Hospital Motol, Prague 150 06, Czech Republic

National Medical Center, National Hemophilia Center, Budapest 1135, Hungary

Klinika Hemetologii I Onkologii Dzieciecej, Warsaw 00-5 76, Poland

Klinika Hematologii i Onkologii Dzieciecej, Wroclaw 50-345, Poland

Additional Information

Starting date: March 2003
Last updated: June 26, 2015

Page last updated: August 23, 2015

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