EUCTR2020-003884-25-DE
Active, not recruiting
Phase 1
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- sickle cell disease (SCD)
- Sponsor
- Forma Therapeutics, Inc.
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 2 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\) 2\-15 episodes of documented vaso\-occlusive crises in the past 12 months
- •4\) Hemoglobin \= 5\.5 and \= 10\.5 g/dL (\= 55 and \= 105 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 acceptable methods of contraception, male patients are willing to use acceptable methods of contraception
- •7\)Patients on crizanlizumab or L\-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:
- •Have been on a stable dose for \= 12 months at the time of consent (i.e., no changes to the dose except for changes to weight or for safety reasons)
- •Have been \= 80% compliant with the planned regimen during the 12 months prior to the time of consent
- •Meet the VOC eligibility requirement in Inclusion Criterion 4
Exclusion Criteria
- •Medical Conditions
- •1\) More than 15 vaso\-occlusive crises within the past 12 months prior to screening
- •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
Similar Trials
Not yet recruiting
Not Applicable
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease (PRAISE)PACTR202202745054588Forma Therapeutics Inc.344
Active, not recruiting
Phase 1
This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).sickle cell disease (SCD)MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2020-003884-25-FRForma Therapeutics, Inc.344
Active, not recruiting
Phase 1
This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).EUCTR2020-003884-25-ESForma Therapeutics, Inc.344
Active, not recruiting
Phase 1
This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).Sickle cell disease (SCD)MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2020-003884-25-ITFORMA THERAPEUTICS, INC.344
Recruiting
Phase 2
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell DiseaseSickle Cell DiseaseSCDLBCTR2021124934Forma Therapeutics, Inc.344