Pegtibatinase as a Treatment for Patients With Classical Homocystinuria (HCU) (Also Known as the COMPOSE Study)
← catalyst calendarNCT03406611 · readout ≤ 346 d
Sponsored by Travere Therapeutics, Inc. (industry) · TVTX — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
39estimated
Sites
12
Countries
France, Qatar, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-01-22 | actual | When the study began enrolling |
| Primary completion | Jul 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2018-01-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Homocystinuria
Interventions
- Drug: Pegtibatinase — also filed as TVT-058, OT-58, PEG modified CBS, PEG htCBS C15S, htCBS C15S ME-200GS
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFIncidence of AEs
measured • Cohorts 1-6: Through double-blind study completion, approximately 10 months per patient • Cohort 7: First dose through End of Treatment (up to 32 weeks)
Anti-pegtibatinase antibodies
measured • Cohorts 1-6: Through double-blind study completion, approximately 10 months per patient • Cohort 7: First dose through End of Treatment (up to 32 weeks)
Anti-PEG antibodies
measured • Cohorts 1-6: Through double-blind study completion, approximately 10 months per patient • Cohort 7: First dose through End of Treatment (up to 32 weeks)
Incidence of hypermethioninemia (Cohort 7 only)
measured First dose through End of Treatment (up to Week 32)
Incidence of hypomethioninemia (Cohort 7 only)
measured First dose through End of Treatment (up to Week 32)
The proportion of participants requiring dietary protein rescue (Cohort 7 only)
measured First dose through End of Treatment (up to Week 32)
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