To study the long term effect of Human-cl rhFVIII (a highly purified blood clotting Factor VIII) in subjects who completed previous study Gena-05 (a study evaluating the effect of Human-cl rhFVIII in Patients with Severe Haemophilia A i.e. a rare bleeding disorder).

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/11/006373
• Date of registration: 20-11-2015
• Prospective Registration: Yes
• Primary sponsor: Octapharma Pharmazeutika ProduktionsgesmbH
• Public title: To study the long term effect of Human-cl rhFVIII (a highly purified blood clotting Factor VIII) in subjects who completed previous study Gena-05 (a study evaluating the effect of Human-cl rhFVIII in Patients with Severe Haemophilia A i.e. a rare bleeding disorder).
• Scientific title: Extension Study for Patients who completed GENA-05 (Nuprotect)-to Investigate Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII.
• Date of first enrolment: 02-01-2016
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12386
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 3

Countries of recruitment

Canada, India, Ukraine, United Kingdom, United States of America

Contacts

• Name: Dr Sonika Newar
• Affiliation: JSS MEDICAL RESEARCH INDIA PRIVATE LIMITED

• Name: Dr Shariq Anwar
• Affiliation: JSS MEDICAL RESEARCH INDIA PRIVATE LIMITED

Key inclusion & exclusion criteria

Inclusion criteria: 1) Patients who completed GENA-05 in accordance with the study protocol.

2) Voluntarily given, fully informed written & signed consent obtained before any study related procedures are conducted(obtained from patients parents/ legal guardian)


Exclusion criteria: 1) Severe Liver or Kidney Disease(alanine amino transferase-ALT or aspartate transaminase (AST) Levels >5 times of upper limit of normal, creatinine. >120 μmol

2) Concomitant treatment with any systemic immunosuppressive drug

3) Other FVIII concentrate than Human-cl rhFVIIII was received between completion visit of GENA-05 & start of GENA-15 (except emergency cases)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: D66- Hereditary factor VIII deficiency

Intervention(s)

Intervention1: NuProtect (Human Cell line, Recombinant Factor VIII): â?¢ Dosage form: Human-cl rhFVIII will be provided in single use vials containing a nominal potency of 250, 500, 1000 or 2000 International Units (IU) each of freeze-dried recombinant FVIII (rFVIII) concentrate to be reconstituted in 2.5 mL of water for injection. Human-cl rhFVIII is to be used as intravenous injection only (maximally 4 mL/minute).


â?¢ Dose, Frequency of drug administration and Duration of treatment: Please refer to the brief summary for details of Dose and Dosing Schedule.

Control Intervention1: Not applicable.: Not applicable.

Primary Outcome(s)

To Investigate the Immunogenicity of Human-cl rhFVIII in Patients who completed GENA-05 in accordance with the study Protocol.Timepoint: Screening, 6th month, 12th Month, 18th Month and 24th Month (End of the study)

Secondary Outcome(s)

To assess the safety & tolerability of Human-cl rhFVIIITimepoint: Throughout the study.

To assess the efficacy of Human-cl rhFVIII during treatment of bleedsTimepoint: During treatment of bleeds

To assess the efficacy of Human-cl rhFVIII during Prophylactic Treatment (based on the frequency of Spontaneous Break -through Bleeds).Timepoint: Screening, 6th month, 12th Month, 18th Month and 24th Month (End of the study)

To assess the efficacy of Human-cl rhFVIII in surgical prophylaxisTimepoint: During surgery.

Secondary ID(s)

Gena-15, Version 02 dated 23 April 2018

Source(s) of Monetary Support

Octapharma Pharmazeutika Produktionsges.m.b.H, Address: Oberlaaer Strasse 235, A-1100 Vienna, Austria

Secondary Sponsor(s)

JSS Medical Research India Private Limited

Ethics review

Status: Approved
Approval date: 22/06/2018
Contact:

Sahyadri Hospitals Ltd Ethics Committee

Status: Approved
Approval date: 12/07/2018
Contact:

Ethics Committee-Silver-Christian Medical College Vellore

Results

• Date Completed: 26/06/2019