Pegtibatinase As an Enzyme Therapy for Patients with Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (COMPOSE)
Public ClinicalTrials.gov record NCT03406611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double Blind, Randomized, Placebo-controlled, Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects on Clinical Outcomes of Pegtibatinase (TVT-058), Administered Subcutaneously in Patients with Cystathionine Beta-Synthase Deficient Homocystinuria (COMPOSE)
Study identification
- NCT ID
- NCT03406611
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Travere Therapeutics, Inc.
- Industry
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- Pegtibatinase Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 21, 2019
- Primary completion
- May 31, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Nov 21, 2024
2019 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Travere Investigational Site - Virtual Site | Culver City | California | 90230 | — |
| Travere Investigational Site | Aurora | Colorado | 80045 | — |
| Travere Investigational Site | Miami | Florida | 33136 | — |
| Travere Investigational Site | Indianapolis | Indiana | 46202 | — |
| Travere Investigational Site | Portland | Maine | 04102 | — |
| Travere Investigational Site | Boston | Massachusetts | 02115 | — |
| Travere Investigational Site | New York | New York | 10029 | — |
| Travere Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03406611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 21, 2024 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03406611 live on ClinicalTrials.gov.