Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2009 |
| End Date: | March 2013 |
A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy
The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of
prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period
(split into two six month treatment periods). The study will compare 2 different methods
(assays) for measuring the amount of study drug, the chromogenic substrate assay per
European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted,
CS/ADJ). During one six month period patients will receive the study drug where the dose has
been measured using the" (CS/EP) and during the other six months period the dose will be
measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)
prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period
(split into two six month treatment periods). The study will compare 2 different methods
(assays) for measuring the amount of study drug, the chromogenic substrate assay per
European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted,
CS/ADJ). During one six month period patients will receive the study drug where the dose has
been measured using the" (CS/EP) and during the other six months period the dose will be
measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)
Inclusion Criteria:
- Male, aged 12 to 65 years
- Severe hemophilia A defined as < 1% FVIII:C
- >/= 150 days of previous treatment with FVIII in lifetime
- Currently receiving on-demand or any type of prophylaxis treatment regimen with any
FVIII product
- No history of or current FVIII inhibitors
Exclusion Criteria:
- Presence of another bleeding disease that is different from hemophilia A (e.g., von
Willebrand disease, hemophilia B)
- Low platelet count, abnormal kidney function, or liver disease
- Received treatment with immune suppressing drugs within the last 3 months prior or
requires treatment during the study. (Some drugs for hepatitis C, Human
immunodeficiency virus (HIV), and steroids are allowed)
- Receiving or has received other experimental drugs within 3 months prior to study
entry
- Allergy to Factor VIII or hamsters or mouse protein
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