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NCT06247085 · ClinicalTrials.gov registry record · Phase 3
A 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 Treatment
A Phase 3 study of Homocystinuria, sponsored by Travere Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06247085 is a Phase 3 study of Homocystinuria that is active but no longer recruiting, run by Travere Therapeutics. The registered enrollment target is 70 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06247085, a Phase 3 study of Homocystinuria, is active but no longer recruiting, sponsored by Travere Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to measure efficacy and safety of pegtibatinase treatment compared with placebo in participants with classical HCU receiving standard of care who have not achieved tHcy target levels. Study details include: * Total Study duration: up to 38 weeks * Screening: * Initial Screening duration: up to 4 weeks * Pre-treatment Diet Standardization Period duration: up to 6 weeks * Blinded Treatment Duration: 24 weeks * 2-week blinded dose titration period * 22-week blinded assessment period * Safety Follow-Up: 4 weeks after last dose (as applicable for those not enrolling in the long term extension study, ENSEMBLE)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Pegtibatinase
Study Locations (1)
North Carolina
- Travere Investigational Site - Virtual Site - Morrisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-12-28 |
| Est. Completion | 2026-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06247085
The ClinicalTrials.gov registry entry for NCT06247085 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Travere Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Homocystinuria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06247085 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06247085 about?
NCT06247085 is a clinical study titled "A 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 Treatment". The purpose of this study is to measure efficacy and safety of pegtibatinase treatment compared with placebo in participants with classical HCU receiving standard of care who have not achieved tHcy target levels. Study details include: * Total Study duration: up to 38 weeks * Screening: * Initia...
What is the current status of trial NCT06247085?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2023-12-28. Estimated completion is 2026-01.
What conditions does trial NCT06247085 study?
This clinical trial studies the following conditions: Homocystinuria.
What interventions are being tested in trial NCT06247085?
The interventions under investigation include: Placebo (OTHER), Pegtibatinase (DRUG).
Who is sponsoring clinical trial NCT06247085?
This trial is sponsored by Travere Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06247085 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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