The safety and efficacy of plasma-derived factor VIII concentrate produced by National Blood Center, Thai Red Cross Society

Phase 3

• Conditions: Hemophilia patients with factor VIII clotting activity less than five percent activity and no antibody.; Hemophilia A, factor VIII concentrate, factor VIII activity

• Registration Number: TCTR20170228002
• Lead Sponsor: Thai Hematology Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-28
• Study Completion: 2017-06-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Hemophilia A patient, age equal to or more than ten years of age.

Exclusion Criteria

Hemophilia A patients with inhibitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incremental level of factor VIII clotting activity at 30 minutes Percent/1 unit of factor VIII concentrate/kg,Half life of infused factor VIII concentrate at 30 minutes, 4 hours and 24 hours Hour

Secondary Outcome Measures

Name	Time	Method
Inhibitor at 3 months Bethesda unit,Infectious markers at 3 months Positive test