ISRCTN17414946
Completed
Phase 1
A pilot study to evaluate the safety and efficacy of interferon beta-1a (IFN ß-1a) in the treatment of patients presenting with Ebola virus illness
Sustainable health Foundation (FOSAD) & Center of Excellence for Training on Research and Priority Diseases (CEFORPAG)0 sites50 target enrollmentJuly 19, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute ebola virus disease
- Sponsor
- Sustainable health Foundation (FOSAD) & Center of Excellence for Training on Research and Priority Diseases (CEFORPAG)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321269/ (added 01/03/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Able to provide informed consent (ubstitute decision maker may provide informed consent in cases where the patient is ill and unable to provide informed consent)
- •2\. Aged between 18 and 70 years on the day of inclusion
- •3\. In the treatment centre
- •4\. Confirmed ebola virus infection by RT\-PCR
- •5\. Symptom onset \< 6 days
- •6\. Able to comply with trial procedures
Exclusion Criteria
- •1\. Known hypersensitivity to IFN ß preparations
- •2\. Pregnancy
- •3\. Chronic liver disease with synthetic dysfunction and/or decompensation, history of bleeding
- •4\. Moderate to severe congestive heart failure \- grade III or IV left ventricular function
- •5\. Previous history of serious psychiatric illness
- •6\. History of sever or active autoimmune disease
Outcomes
Primary Outcomes
Not specified
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