Status:
COMPLETED
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Lead Sponsor:
Cardurion Pharmaceuticals, Inc.
Collaborating Sponsors:
Imara, Inc.
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or sickle-β0 thalassemia).
Detailed Description
This is a proof-of-concept study in adult SCA participants, ages 18 to 55 years old, to examine the safety, tolerability, and pharmacokinetic (PK), as well as the potential pharmacodynamic (PD) effect...
Eligibility Criteria
Inclusion
- Key
- Male or female participants with confirmed SCA
- Age 18 to 55 years, inclusive
- For participants on HU, must have been on a stable dose for at least 60 days prior to screening
- Key
Exclusion
- Total hemoglobin \>12.5 or \<6 grams/deciliter
- Red blood cell transfusion within 60 days of baseline
- \>7 hospitalizations for vaso-occlusive crises (VOCs) within the last year
- Estimated glomerular filtration rate \<50 milliliter/minute
- Aspartate aminotransferase/alanine aminotransferase \>3x the upper limit of normal
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03401112
Start Date
January 26 2018
End Date
August 28 2020
Last Update
May 15 2025
Active Locations (13)
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1
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
2
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
3
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States, 33021
4
University of Illinois
Chicago, Illinois, United States, 60612