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HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP

StatusEnrolling by Invitation
PhasePhase 2/3
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Eligibility criteria expanded, about 16 words
    • Site details revised at 4 of 26 sites
  4. Study sites: 25 to 26v20
  5. Study sites: 23 to 25v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 22 to 23v18
  2. Study sites: 21 to 22v17
  3. Study sites: 20 to 21v16
  4. Study sites: 19 to 20v15
  5. Study sites: 17 to 19v14
  6. Study sites: 16 to 17v13
  7. Study sites: 15 to 16v12
  8. Study sites: 14 to 15v11
  9. Study sites: 13 to 14v10
  10. Enrollment target: 200 to 230
    • Eligibility criteria expanded, about 77 words
    • Study title expanded, about 3 words
    v9
  11. Re-verified, no change to tracked fieldsv8
  12. Study sites: 11 to 13v7
  13. Eligibility criteria expanded, about 26 wordsv6
  14. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 12 to 11
    • Start date changed from estimate of Sep 2023 to Aug 31, 2023
    v5
  15. Start date: Jun 2023 to Sep 2023v4
  16. Primary endpoints revised (6)v3
  17. Primary endpoints: 1 to 6v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.
Trial Details
NCT Number NCT05883748
Lead Sponsor Disc Medicine, Inc
Conditions
(from sponsor)		 Erythropoietic Protoporphyria
Related terms Porphyrias, Protoporphyria, Erythropoietic
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov