CTRI/2018/05/013790
Completed
Phase 4
Prospective, multi-centre, clinical study to evaluate theefficacy, safety and pharmacokinetics of HemoRel-A® in Hemophilia A patients
Dr Savita Rangarajan0 sites44 target enrollmentTBD
ConditionsHealth Condition 1: null- Hemophilia A
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Hemophilia A
- Sponsor
- Dr Savita Rangarajan
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male subjects aged between 18 to 65 years (both inclusive.
- •2\.Subjects with severe hemophilia A (documented factor VIII levels lesser than 1 percent) who are
- •receiving on\-demand treatment.
- •3\.History of greater than 12 bleeding events in the past 12 months.
- •4\. Number of exposure days before inclusion greater than 50 ED.
- •5\.Immunocompetent with CD4 lymphocytes greater than 200/μl.
- •6\. HIV negative or having a viral load less than 200 particles/μl approx 400000 copies/ml.
- •7\.Willing to provide written Informed Consent.
- •8\.Able to adhere to study schedules and requirements.
Exclusion Criteria
- •1\. Subjects with history of inhibitors to FVIII
- •2\. Any other inherited or acquired bleeding disorder
- •3\. Subjects with any major systemic illness, and/or had known hypersensitivity to
- •HemoRel\-A® or any of its component.
- •4\. Subjects with abnormal laboratory parameters like:
- •ï?§ Serum creatinine greater than 1\.5 times of upper normal limit
- •ï?§ AST or ALT greater 3 times of upper normal limit
- •ï?§ Platelet count less than 100,000/μL
- •ï?§ Hemoglobin less than 10\.0 gm/dL
- •ï?§ Neutrophils less than 1\.5 X 10 raised to 3/μL
Outcomes
Primary Outcomes
Not specified
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