TrialA 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)
Trial details
- Registry ID
- NCT06431893
- Phase
- Phase 3
Drug research
Pegtibatinase
Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.
Drug identity checked against registry records
Also recorded as OT-058; OT-58; TVT-058
A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.
Included trials
| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| 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)NCT06431893 | TVTX | Phase 3 | Enrolling by invitation | 2030-08Estimated |
| 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 TreatmentNCT06247085 | TVTX | Phase 3 | Recruiting | 2027-08Estimated |
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
Trial details
- Registry ID
- NCT06247085
- Phase
- Phase 3
Regulatory dates and decisions
| No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed. |