Status:
ACTIVE_NOT_RECRUITING
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
Lead Sponsor:
Imara, Inc.
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerab...
Detailed Description
This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Stud...
Eligibility Criteria
Inclusion
- Completed Study IMR-SCD-102.
- Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
- Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
- Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.
Exclusion
- Subjects with Hb \>12.5 g/dL or \<6 g/dL
- Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
- eGFR \<50 mL/min
- AST/ALT \> 3x the upper limit of normal
Key Trial Info
Start Date :
May 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04053803
Start Date
May 22 2019
End Date
March 1 2025
Last Update
March 4 2022
Active Locations (7)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
2
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States, 33021
3
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States, 76508
4
Bristol Haematology and Oncology Centre
Bristol, United Kingdom