EUCTR2020-003884-25-ES
Active, not recruiting
Phase 1
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Forma Therapeutics, Inc.
- Enrollment
- 344
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Provision of consent
- •2\) Patient has a confirmed diagnosis of sickle cell disease
- •3\) At least 2 episodes of vaso\-occlusive crises in the past 12 months
- •4\) Hemoglobin \= 5\.5 and \= 10 g/dL (\= 55 and \= 100 g/L) during screening
- •5\) Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
- •6\) Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 302
Exclusion Criteria
- •Medical Conditions
- •1\) More than 10 vaso\-occlusive crises within the past 12 months
- •2\) Female who is breast feeding or pregnant
- •3\) Hepatic dysfunction characterized by:
- •\- Alanine aminotransferase (ALT) \> 4\.0 × upper limit of normal (ULN)
- •\- Direct bilirubin \> 3\.0 × ULN
- •4\) Known HIV positive
- •5\) Active hepatitis B or hepatitis C infection
- •6\) Severe renal dysfunction or on chronic dialysis
- •7\) History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
Outcomes
Primary Outcomes
Not specified
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Phase 1
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