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Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: 7 to 6v16 Show 4 more changesShow less
    • Interventions: SPK-8011 (Genetic) to SPK-8011 (Genetic), SPK-8016 (Genetic)
    • Eligibility criteria revised
    • Secondary endpoints shortened, about 13 words
    • Study description revised
  2. Re-verified, no change to tracked fieldsv15
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 29
    v14
  4. Study sites: 11 to 12v13
  5. Study sites: 10 to 11v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Dec 2022 to Dec 2032v11
  2. Re-verified, no change to tracked fieldsv10
  3. Enrollment target: 100 to 40v9 Show 4 more changesShow less
    • Study sites: 7 to 10
    • Eligibility criteria expanded, about 20 words
    • Study description expanded, about 4 words
    • Study title expanded, about 2 words
  4. Re-verified, no change to tracked fieldsv8
  5. Study sites: 2 to 7v7
  6. Re-verified, no change to tracked fieldsv6
  7. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 2018 to Aug 14, 2018
    v5
  8. Start date: May 2018 to Jul 2018
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 1 word
    v4
  9. Start date: Mar 2018 to May 2018v3
  10. Secondary endpoints: details revised at 1 of 6 entriesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This long-term follow-up study will continue to evaluate the long-term safety and efficacy of SPK-8011 and SPK-8016 in males with hemophilia A, who have received a single intravenous administration of SPK-8011 or SPK-8016 in any Spark-sponsored SPK-8011 or SPK-8016 study.
Trial Details
NCT Number NCT03432520
Lead Sponsor Spark Therapeutics, Inc.
Conditions
(from sponsor)		 Hemophilia A
Related terms Hemophilia A
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov