A Double Blind, Randomized, Placebo-controlled, Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects on Clinical Outcomes of OT-58, Administered Subcutaneously in Patients With Cystathionine Beta-Synthase Deficient Homocystinuria (CBSDH).
Not yet recruiting
Phase of Trial: Phase I/II
Latest Information Update: 04 Apr 2018
At a glance
- Drugs OT-58 (Primary)
- Indications Homocystinuria
- Focus Adverse reactions
- Sponsors Orphan Technologies
- 26 Mar 2018 Planned number of patients changed from 20 to 12.
- 26 Mar 2018 Planned End Date changed from 1 Jul 2020 to 1 Sep 2019.
- 26 Mar 2018 Planned primary completion date changed from 1 Apr 2020 to 1 Sep 2019.