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A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan

Study acronym: PROTECT-ALT
StatusActive, Not Recruiting
PhaseNot specified
SponsorSanofi
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 3 entries Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 79 participants (planned 100)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 11 of 37 entries
    • Site details revised at 10 of 10 sites
  2. Start date: Jan 13, 2024 to Nov 11, 2024
    • Site details revised at 3 of 10 sites
    v5
  3. Enrollment target: 120 to 100v4 Show 4 more changesShow less
    • Study sites: 8 to 10
    • Start date: Nov 11, 2024 to Jan 13, 2024
    • Eligibility criteria revised
    • Secondary endpoints: 40 to 37
  4. Study sites: 5 to 8v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 10 to 5
    • Start date changed from estimate of Jan 13, 2025 to Nov 11, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
Hemophilia
241 trials monitored
See 12 trials at risk
This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. The data related to efanesoctocog alfa effectiveness, safety and usage will be recorded prospectively during routine visits for up to 5 years following enrollment initiation and the retrospective data will be collected at least 12 months and up to 24 months prior to efanesoctocog alfa initiation. Joint imaging data will be collected in centers performing Joint U/S and/or MRI (≥6 years old). At least 12 months of retrospective data will also be collected from medical records, as available. Prospectively collected data will be recorded at routine clinical visits during a five-year follow-up period. The end of study is defined as the last participant's last visit. No intervention will be administered, and no study related visits are required.
Trial Details
NCT Number NCT06684314
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Hemophilia A
Related terms Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders, Genetic Diseases, Inborn, Hemarthrosis, Hematologic Diseases, Hemophilia A, Hemorrhagic Disorders
Enrollment 79 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov