An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102

Locations

1 United States site

Age

> 18 Years

Genotypes

HbSS

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

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 tolerability.

participation requirements

1. Must have been previously enrolled in the IMR-687 study titled: 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)”, i.e., Study
IMR-SCD-102.

2. Female subjects must not be pregnant and be highly unlike to become pregnant. Male
subjects must be unlikely to impregnate their partner.

3. 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

4. Subjects must be willing and able to complete all study assessments and procedures and
to communicate effectively with the investigator and site staff.

participation restrictions

1. Subjects with Hb at screening >12.5 g/dL or <6 g/dL 2. Subjects who test positive for human immunodeficiency virus (HIV), hepatitis C (HCV) antibodies (unless the patient has successfully completed drug therapy that results in cure/clearance of HCV), and hepatitis B surface antigen (HBsAg) 3. Female subjects who test positive for a serum pregnancy test at screening or a urine pregnancy test at Day 1 4. eGFR <50 mL/min 5. AST/ALT > 3x the upper limit of normal

Locations

  • Hollywood, Florida, United States, Foundation for Sickle Cell Disease Research, 33021

More info

View on ClinicalTrials.gov
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