Clinical study for HemoRel-A® in Hemophilia A patients

Phase 4

Completed

• Conditions: Health Condition 1: null- Hemophilia A

• Registration Number: CTRI/2018/05/013790
• Lead Sponsor: Dr Savita Rangarajan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

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

� Platelet count less than 100,000/μL

ï?§ Hemoglobin less than 10.0 gm/dL

� Neutrophils less than 1.5 X 10 raised to 3/μL

5. History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular,

gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease.

6. Subject participation in any other clinical trial 30 days prior to administration of IP.

7. Any other condition which investigator feels would affect interpretation of the

results or render the subject at high risk.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response of acute bleeding events to treatment based on a 4-point scale (excellent, good, moderate or none)Timepoint: Response of acute bleeding will be assessed at 8 Hours and at 72 hours

Secondary Outcome Measures

Name	Time	Method
Evaluation of safetyTimepoint: 0, 3, 8, 24, 72 hrs;ImmunogenecityTimepoint: Baseline and End of study;Pharmacokinetic assessmentTimepoint: pre-infusion (within 15 minutes prior to infusion), and 10 minutes (end of <br/ ><br>infusion), 30 minutes, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion