Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06149403 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT

Study acronym: HURCULES
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv11
  2. Study sites: 6 to 5v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 41
    • Site details revised at 6 of 6 sites
    v9
  4. Study sites: 7 to 6v8
  5. Secondary endpoints revised (6)
    • Study sites revised (7)
    • Eligibility criteria expanded, about 4 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site contacts updated at 1 of 7 sitesv6
  2. Secondary endpoints revised (6)
    • Site details revised at 2 of 7 sites
    • Eligibility criteria shortened, about 1 word
    v5
  3. Site details revised at 1 of 7 sitesv4
  4. Start date changed from estimate of Dec 2023 to Dec 11, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 14 words
    • Study sites revised (7)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).
Trial Details
NCT Number NCT06149403
Lead Sponsor Orchard Therapeutics
Conditions
(from sponsor)		 MPS-IH (Hurler Syndrome)
Related terms Mucopolysaccharidoses, Mucopolysaccharidosis I
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov