Enrolling by invitationPhase 3NCT06431893
A Phase 3 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)
Studying Homocystinuria
Last synced from ClinicalTrials.gov
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Clinical trial records are synced from ClinicalTrials.gov through automated extraction.
Report missing dataKey facts
- Sponsor
- Travere Therapeutics, Inc.
- Principal Investigator
- Michael Imperiale, MDTravere Therapeutics, Inc.
- Intervention
- Pegtibatinase(drug)
- Enrollment
- 100 enrolled
- Eligibility
- 5-65 years · All sexes
- Timeline
- 2024 – 2027
Study locations (4)
- Travere Investigational Site, Portland, Maine, United States
- Travere Investigational Site, New York, New York, United States
- Travere Investigational Site - Virtual Site, Morrisville, North Carolina, United States
- Travere Investigational Site, Philadelphia, Pennsylvania, United States
Primary source
Recruitment status, site addresses, contacts, and full eligibility criteria can change between syncs. Always verify with the trial team before planning travel or treatment.
Open NCT06431893 on ClinicalTrials.govOther trials for Homocystinuria
Additional recruiting or active studies for the same condition.
- RECRUITINGNCT06556615Health Related Quality of Life (HrQoL) in Classical Homocystinuria (CBS Deficiency)University Children's Hospital, Zurich
- ACTIVE NOT RECRUITINGNANCT06495567Proof of Concept Creatine Supplementation for Homocystinuria StudyUniversity of British Columbia
- ACTIVE NOT RECRUITINGPHASE3NCT06247085A Study to Investigate Efficacy and Safety of Pegtibatinase Compared With Placebo in Participants ≥12 to ≤65 Years of Age With Classical Homocystinuria (HCU) Due to Cystathionine Beta Synthase Deficiency Receiving Standard of Care TreatmentTravere Therapeutics, Inc.
- ACTIVE NOT RECRUITINGPHASE1, PHASE2NCT03406611Pegtibatinase As an Enzyme Therapy for Patients with Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (COMPOSE)Travere Therapeutics, Inc.
- RECRUITINGNCT02998710Natural History Study of Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (ACAPPELLA)Travere Therapeutics, Inc.