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).

Trial Profile

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
  • Most Recent Events

    • 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.
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