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A Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥5 to ≤65 Years of Age With Classical Homocystinuria (HCU) (ENSEMBLE)

Study acronym: ENSEMBLE
StatusEnrolling by Invitation
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Jan 2027 to Aug 2030v6 Show 5 more changesShow less
    • Study sites: 4 to 52
    • Secondary endpoints: 1 to 3
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 5 words
    • Study title shortened, about 2 words
  2. Site details revised at 1 of 4 sites
    • Study title revised
    v5
  3. Enrollment target: 90 to 100
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study title expanded, about 1 word
    v4
  4. Study sites: 3 to 4v3
  5. Study sites: 1 to 3v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this long-term extension (LTE) study is to evaluate the safety and efficacy of pegtibatinase in patients with classical homocystinuria (HCU). Patients who are active in the Phase 1/2 COMPOSE study or those who complete the 24 weeks of blinded treatment in the Phase 3 HARMONY are eligible to participate. Participants will be in this clinical study for a minimum of 108 weeks including: * a treatment period of up to 104 weeks * a 4-week safety follow-up period
Trial Details
NCT Number NCT06431893
Lead Sponsor Travere Therapeutics, Inc.
Conditions
(from sponsor)		 Homocystinuria
Related terms Homocystinuria
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov