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).

Extension Study for Patients who completed GENA-05 (Nuprotect)-to Investigate Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/11/006373

Enrollment

100

Registered

2015-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D66- Hereditary factor VIII deficiency

Interventions

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 Inter

Eligibility

Inclusion 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

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 Î¼mol 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 during treatment of bleedsTimepoint: During treatment of bleeds;To assess the efficacy of Human-cl rhFVIII in surgical prophylaxisTimepoint: During surgery.;To assess the safety & tolerability of Human-cl rhFVIIITimepoint: Throughout the study.	—

Measure

Time frame

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 during treatment of bleedsTimepoint: During treatment of bleeds;To assess the efficacy of Human-cl rhFVIII in surgical prophylaxisTimepoint: During surgery.;To assess the safety & tolerability of Human-cl rhFVIIITimepoint: Throughout the study.

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Countries

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

Contacts

Public ContactDr Shariq Anwar

JSS MEDICAL RESEARCH INDIA PRIVATE LIMITED

sonika.newar@jssresearch.com1296613500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026