Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

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Overview

This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Severe Hemophilia A

Interventions

recombinant Factor VIIIBIOLOGICAL

intravenous infusion of factor FVIII every other day.

Eligibility

Sex: MALEMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Severe hemophilia A ((FVIII:C \<= 1%) * Male subjects \>= 12 years of age * Previously treated with FVIII concentrate, at least 50 EDs * Immunocompetent (CD4+ count \> 200/ul) * Negative for anti- HIV; if positive, viral load \< 200 particles/u; or \<400,000 copies/mL Exclusion Criteria: * Other coagulation disorder than hemophilia A * Present of past FVIII inhibitor activity (.= 0.6 BU) * Severe liver and kidney disease * Receiving of scheduled to receive immuno-modulating drugs

Locations (11)

Medizinische Universitaet Wien

Vienna, Austria

Haematological Hospital Joan Pavel

Sofia, Bulgaria

Werlhof Institut fuer Haemostaseologie GmbH

Hanover, Lower Saxony, Germany

Outcomes

Primary Outcomes

Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months

Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.

Time frame: At least 50 Exposure Days and at least 6 months

Efficacy of Treating Bleeding Episodes

At the end of a bleeding episode, efficacy was assessed as: * Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion * Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution * Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution * None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated

Time frame: After each bleeding episode, up to 6 month

Data from ClinicalTrials.gov

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