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Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia — VITHAL  

Beta-Thalassemia Clinical Trial

Official title:
A Phase 2a, Double-blind, Randomised, Placebo-controlled, Parallel Group, Multicentre Study on Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Multiple Doses of VIT-2763 in Subjects With Non-transfusion Dependent β-thalassaemia

Clinical Trial Summary

This is a randomised, double-blind, placebo-controlled parallel group trial to investigate the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in participants with non-transfusion-dependent Beta-thalassemia (NTDT).

Clinical Trial Description

The study includes a 12-week treatment period and a safety follow-up period of 4 weeks. About 36 participants (adults and adolescents) are expected to take part in this study at a number of different institutions internationally. Adult Participants (Cohort I) will be randomized to receive either VIT-2763 once daily (QD) or twice daily (BID) or placebo, at a dose of 120 mg or 60mg depending on their body weight. Following cohort I review, adolescent participants (Cohort II) will be randomized to the same study arms with the same interventions. The study medication will be given as oral capsules, containing 60 mg of VIT-2763 or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04364269
Study type Interventional
Source Vifor Pharma
Contact
Status Completed
Phase Phase 2
Start date June 11, 2020
Completion date November 3, 2021
View Details
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