HEMOCT INDIANCT07446010
Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India
At risk: Primary completion moved at least 6 months later, primary endpoint(s) modified.
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Record History
All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
Notable Primary and study completion pushed from Sep 30, 2027 to Mar 31, 2028 Show 8 more changesShow less
- Primary endpoint(s) modified
- Start date: Sep 1, 2026 to Apr 5, 2027
- Eligibility criteria expanded, about 9 words
- Trial sites reduced: 6 → 0 locations
- Enrollment target: 33 to 30
- Secondary endpoints: details revised at 2 of 7 entries
- Collaborators expanded, about 7 words
- Study title expanded, about 1 word
- Notable Primary and study completion pushed from Dec 31, 2026 to Sep 30, 2027
- Start date: May 29, 2026 to Sep 1, 2026
- Notable Start date: Mar 10, 2026 to May 29, 2026v2
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs)
Timeframe: 12 weeks
Secondary (7)
Total number of infusions per bleed
Dose of Octocog alfa (IU/kg) per bleed
Location of bleeds
Type of bleeds
Severity of bleeds
Show 2 moreShow less
Duration of bleeds
Investigator rating of response
Arms and interventions
Male adult patients (aged ≥18 years) with severe Hemophilia A in India, who have been previously tre
Drugs: Octocog alfa