NCT04053803Active, not recruitingPhase 2
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Jul 2019
- Start date
- 22 May 2019
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Imara, Inc.
- Diseases
- Sickle cell disease, Thalassaemia
- NCT number
- NCT04053803
- EudraCT number
- 2018-003805-25
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 22 May 2019 to the primary completion date, 31 Mar 2025
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Subjects with Hb \>12.5 g/dL or \<6 g/dL
- eGFR \<50 mL/min
- AST/ALT \> 3x the upper limit of normal
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bristol Haematology and Oncology Centre Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Guy's and St Thomas Hospital CRF Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University of Connecticut Health Center Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| Foundation for Sickle Cell Disease Research Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Baylor Scott & White Medical Center - Temple Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.