EUCTR2021-001639-23-GR
Active, not recruiting
Phase 1
A Phase 2b, double-blind, randomised, placebo-controlled, multicentre study to assess the efficacy and safety of VIT-2763 multiple doses in adults with transfusion-dependent ß-thalassaemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vifor (International) Inc.
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body weight \=40\.0 kg and \=100 kg at screening
- •Documented diagnosis of beta\-thalassaemia or Hb E/beta\-thalassaemia
- •Red blood cell (RBC) transfusion dependence, defined as at least 6 RBC units in the 24 weeks prior to randomisation and no transfusion\-free period for \=35 days during that period
- •Ability to understand the requirements of the study and provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 79
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1
Exclusion Criteria
- •Documented diagnosis of Hb S/beta\-thalassaemia, alfa\-thalassaemia, or delta beta (dß)\- thalassaemia, 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
Outcomes
Primary Outcomes
Not specified
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