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A Long-term Follow-up Study in Participants Who Received CTX001

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv32
  2. Study sites: 19 to 20 Secondary endpoints revised (36)v31 Show 1 more changeShow less
    • Secondary endpoints revised (36)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites revised (19)v30 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion dates: Sep 2039 to Sep 30, 2039 Secondary endpoints revised (36)v29 Show 1 more changeShow less
    • Secondary endpoints revised (36)

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv28
Show 26 earlier versionsHide 26 earlier versions
  1. Study sites: 18 to 19v27
  2. Re-verified, no change to tracked fieldsv26
  3. Study sites: 17 to 18v25
  4. Study sites revised (17)v24 See this version in full on ClinicalTrials.gov ↗
  5. Phase: Not specified to Phase 3 Primary endpoints revised (5) · Enrollment target: 114 to 160 · Eligibility criteria revised · 2 morev23 Show 5 more changesShow less
    • Primary endpoints revised (5)
    • Enrollment target: 114 to 160
    • Eligibility criteria revised
    • Secondary endpoints: 35 to 36
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 16 to 17v22
  7. Study sites: 15 to 16v21
  8. Study sites: 14 to 15v20
  9. Re-verified, no change to tracked fieldsv19
  10. Study sites: 13 to 14v18
  11. Study sites: 12 to 13v17
  12. Study sites: 11 to 12 Start date: Jan 25, 2021 to Jan 20, 2021v16 Show 1 more changeShow less
    • Start date: Jan 25, 2021 to Jan 20, 2021
  13. Re-verified, no change to tracked fieldsv15
  14. Study sites: 10 to 11v14
  15. Enrollment target: 90 to 114 Eligibility criteria expanded, about 14 words · Secondary endpoints: 8 to 35v13 Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 8 to 35

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 9 to 10v12
  17. Re-verified, no change to tracked fieldsv11
  18. Study sites: 8 to 9v10
  19. Study sites: 7 to 8v9
  20. Start date changed from estimate of Feb 2021 to Jan 25, 2021v8
  21. Study sites: 6 to 7v7
  22. Study sites: 5 to 6v6
  23. Study sites: 4 to 5v5
  24. Study sites: 3 to 4v4
  25. Study sites: 1 to 3v3
  26. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Interventions: CTX001 (Biological)v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Interventions: CTX001 (Biological)
  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 a multi-site, open- label rollover study to evaluate the long-term safety and efficacy of CTX001 in pediatric and adult participants who received CTX001 in parent studies 111 (NCT03655678) 141 (NCT05356195) or 161 (NCT05477563) (transfusion-dependent β-thalassemia \[TDT\] studies) or Study 121 (NCT03745287) or 151 (NCT05329649) or 161(NCT05477563) (severe sickle cell disease \[SCD\] studies).
Trial Details
NCT Number NCT04208529
Lead Sponsor Vertex Pharmaceuticals Incorporated
Collaborators: CRISPR Therapeutics
Conditions Beta-Thalassemia, Thalassemia, Sickle Cell Disease, Hematologic Diseases, Hemoglobinopathies, Genetic Diseases, Inborn, Sickle Cell Anemia
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov