A post marketing study to study the pharmacokinetic parameters of Factor VIII in patients with Haemophilia A
Phase 4
Completed
- Registration Number
- CTRI/2009/091/000027
- Lead Sponsor
- Celestial Biologics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Moderate to severe Haemophilia A (defined as ≤ 5% of normal factor VIII)
2.Age ≥ 18 years
3.Absence of FVIII infusion within 7 days prior to enrollment in the study
4.No current bleeding
5.Patient able to provide written informed consent
Exclusion Criteria
1.Any haemorrhagic disorder other than Haemophilia A.
2.Past or present history of FVIII inhibitors
3.History of anaphylactic reaction to human FVIII
4.Major renal or hepatic dysfunction,
5.Participation in a clinical trial within 30 days prior to recruitment and during the study, in another investigational drug study that clinically interferes with the study endpoints
6.Any clinically significant disorder which could affect the evaluation or the patient?s safety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the in-vivo recovery of the Factocel VIII 250 I.U. in patients with moderate to severe Haemophilia ATimepoint: NA
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI