NL-OMON54921
Completed
Phase 2
A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia - IMR-BTL-201
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Beta Thalassemia
- Sponsor
- IMARA, Inc.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible for
- •1\. Subjects must understand and voluntarily provide informed consent and sign
- •an informed consent form (ICF) prior to any study\-related
- •assessments/procedures being conducted. Although RBC transfusions and
- •associated Hb laboratory measurements prior to Screening are not study related,
- •the ICF will specifically request subject consent to collect these data.
- •2\. Subjects must be \>\=18 to \<\=65 years of age at the time of signing the ICF.
- •3\. Subjects must have documented diagnosis of β\-thalassemia or HbE/β\-
- •thalassemia in their medical history. Concomitant alpha gene deletion,
- •duplication, or triplication is allowed.
Exclusion Criteria
- •Subjects meeting any of the following criteria must be excluded from the study:
- •1\. Any significant medical condition, laboratory abnormality, or psychiatric
- •illness that would prevent the subject from participating in the study,
- •including the presence of laboratory abnormalities that may place the subject
- •at unacceptable risk if he/she were to participate in the study.
- •2\. Any situation or condition that confounds the ability to interpret data from
- •the study (e.g., subjects also receiving RBC transfusions at centers not able
- •to obtain laboratory samples for central processing).
- •3\. Diagnosis of a\-thalassemia (e.g., hemoglobin H \[HbH]) or hemoglobin S (HbS)/
- •β thalassemia.
Outcomes
Primary Outcomes
Not specified
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