BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

Bayer

Status and phase: Completed; Phase 4

Conditions: Hematologic Disease; Hemophilia A

Treatments: Drug: Kogenate (BAY14-2222)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586521

2005-002757-45 (EudraCT Number)

11859

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.

Enrollment: 20 patients

Sex: Male

Ages: 30 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe hemophilia A (< 1% FVIII)
• 30-45 years of age
• Previously treated subject (> 100 Exposure days to any FVIII)
• On-demand therapy with any FVIII

Exclusion criteria

• No history of inhibitor
• No planned elective orthopedic surgery during the study duration (13 months)
• No severe concomitant disease
• No history of anaphylactic or other severe reaction to previous FVIII treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

rFVIII-FS (octocog-alfa), (Kogenate FS)

Experimental group

Description:

On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.

Treatment:

Drug: Kogenate (BAY14-2222)