A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Status: | Recruiting |
---|---|
Conditions: | Anemia, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 1/18/2019 |
Start Date: | January 26, 2018 |
End Date: | June 2019 |
Contact: | ShiYin Foo, MD PhD MMSc |
Email: | syfoo@imaratx.com |
Phone: | +1617-231-6721 |
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)
A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687
in adults with Sickle Cell Anaemia (SCA).
in adults with Sickle Cell Anaemia (SCA).
This is a proof of concept study in adult SCA patients, age 18-55 years old. The primary goal
is to examine the safety, pharmacokinetics and preliminary pharmacodynamics of escalating
doses of IMR-687 as compared to placebo.
is to examine the safety, pharmacokinetics and preliminary pharmacodynamics of escalating
doses of IMR-687 as compared to placebo.
Inclusion Criteria:
- Male or female patients with confirmed SCD
- Age 18-55 years, inclusive
- For patients on hydroxyurea, must have been on a stable dose for at least 60 days
prior to screening
Exclusion Criteria:
- Total hemoglobin >12.5 or less than 6 g/dL
- RBC transfusion within 60 days of baseline
- >7 hospitalizations for vasoocclusive crises within the last year
- eGFR < 50 ml/min
- AST/ALT > 3x the upper limit of normal
We found this trial at
9
sites
Univ of Illinois A major research university in the heart of one of the world's...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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263 Farmington Ave
Farmington, Connecticut 06032
Farmington, Connecticut 06032
Principal Investigator: Biree Andemariam, MD
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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