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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Beta-Thalassemia

In brief

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.

Key facts

Study ID

NCT04938635

Run by

Vifor (International) Inc.

People needed

0

Starts

2021-09-20

Expected to finish

2023-07-01

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body weight ≥40.0 kg and ≤100 kg at screening
• Documented diagnosis of beta-thalassemia or Hb E/beta-thalassemia
• Red blood cell (RBC) transfusion dependence, defined as at least 6 RBC units in the 24 weeks prior to randomization and no transfusion-free period for ≥35 days during that period
• Ability to understand the requirements of the study and provide written informed consent

You may not qualify if…

• Documented diagnosis of Hb S/beta-thalassemia, alpha-thalassemia, or delta beta (δβ)-thalassemia, or hereditary persistence of foetal Hb.
• History of partial or total splenectomy within 4 months prior to screening.
• History of myocardial iron overload
• Chronic liver disease or history of liver cirrhosis
• Clinically relevant renal disease
• History or clinically important finding of cardiac disorders
• History of clinically significant lung disease
• Uncontrolled hypertension (> Grade 1 according to NCI CTCAE current version)
• Unable to take and absorb oral medications.
• Pregnancy or breastfeeding
• History of drug or alcohol abuse within 2 years prior to screening
• History or concomitant solid tumors and/or hematological malignancies unless resolved in the ≥5 past years.

Where it is running

• Investigator site #710 — Whittier, California, United States
• Investigational site #802 — Plovdiv, Bulgaria
• Investigational site #801 — Sofia, Bulgaria
• Investigational site #804 — Stara Zagora, Bulgaria
• Investigator Site 404 — Jerusalem, Israel
• Investigator Site 406 — Petah Tikva, Israel
• Investigator Site 405 — Safed, Israel

Full record on ClinicalTrials.gov

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