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Efficacy and Safety Study of Multiple Doses of VIT-2763 in Adults With Transfusion-dependent Beta-thalassemia

NCT04938635 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-11-10

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the efficacy of 3 multiple doses of VIT-2763 as measured by the reduction in red blood cell (RBC) transfusion burden from Week 13 to Week 24, to identify the most efficacious and safe dose.

Conditions

Interventions

DRUG

VIT-2763 60 mg QD

Participants receive one VIT-2763 60 mg capsule plus one Placebo capsule orally in the morning, and 2 Placebo capsules orally in the evening, for 24 weeks.

DRUG

VIT-2763 60 mg BID

Participants receive one VIT-2763 60 mg capsule plus one Placebo capsule orally, twice daily for 24 weeks.

DRUG

VIT-2763 120 mg BID

Participants receive two VIT-2763 60 mg capsules orally, twice daily for 24 weeks.

DRUG

Placebo

Participants receive two Placebo capsules matching VIT-2763 orally, twice daily for 24 weeks.

Sponsors & Collaborators

  • Labcorp Corporation of America Holdings, Inc

    collaborator INDUSTRY

  • Vifor (International) Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Szecsödy · Vifor (International) Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938635 on ClinicalTrials.gov