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Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A

NCT00879541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2011-02-11

No results posted yet for this study

Summary

The aim of this study are to

* assess the efficacy of Biostate® \[Study Product (SP)\] in subjects with Haemophilia A
* compare the pharmacokinetics of Biostate® \[SP\] with the previously marketed product Biostate® (here referred to as Biostate® \[Reference Product (RP)\]).

This study is divided into 3 parts:

Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to determine the order in which they receive the two study products. This part of the study is double-blinded.

Part 2: Efficacy component. All subjects will receive Biostate® \[SP\] as required to manage their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure days) to assess efficacy and safety of the product. This part of the study is open-label.

Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component) will undergo a repeat PK assessment on Day 180 following administration of Biostate® \[SP\].

Conditions

Interventions

BIOLOGICAL

Biostate® [SP]

Single bolus intravenous dose of 50 IU/kg

BIOLOGICAL

Biostate® [SP]

The dose is dependent on the reason for use and may consist of repeated bolus doses as required to manage haemophilia condition.

BIOLOGICAL

Biostate® [RP]

Single bolus intravenous dose of 50 IU/kg.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • CSL Behring

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Bulgaria
  • North Macedonia
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879541 on ClinicalTrials.gov