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Active Not RecruitingPhase 1/2

Pegtibatinase As an Enzyme Therapy for Patients with Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (COMPOSE)

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)

NCT03406611•Travere Therapeutics, Inc.

View on ClinicalTrials.gov

AI summary by Clareo Health

Generating AI summary...

Conditions

Homocystinuria

Interventions

Pegtibatinase

Placebo

Locations

8

United States

Locations (8)

Travere Investigational Site - Virtual Site

Culver City, California, United States

Travere Investigational Site

Aurora, Colorado, United States

Travere Investigational Site

Miami, Florida, United States

Travere Investigational Site

Indianapolis, Indiana, United States

Travere Investigational Site

Portland, Maine, United States

Travere Investigational Site

Boston, Massachusetts, United States

Key Dates

Start Date

January 22, 2019

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

November 22, 2024

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COMPLETEDPhase 2

Homocystinuria: Treatment With N-Acetylcysteine

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Sponsors

Lead Sponsor

Travere Therapeutics, Inc.

Full Eligibility Criteria

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2024Data synced to Clareo: April 27, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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