Hepatitis E Clinical Trial
Official title:
Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms
NCT number | NCT02558114 |
Other study ID # | RACHE |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | November 2018 |
Verified date | April 2019 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to compare the efficacy, safety and recurrence rate of two
therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute
hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the
viremia within 4 weeks of the start of treatment (12 vs 24 weeks).
The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing
dose adjusted to renal function, plasma levels of drug and hemoglobin.
Status | Terminated |
Enrollment | 5 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age equal or greater than 18 years. - To comply with any of the following diagnoses: - chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months . - severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease. - Signed informed consent Exclusion Criteria: - Terminal illness with a expected life expectancy of less than 6 months - Patients with contraindications for treatment with Ribavirin: - pregnancy or lactation. - Severe hepatic impairment or decompensated cirrhosis. - hemoglobinopathies (thalassemia, sickle cell anemia). - history of severe pre-existing cardiac disease, including unstable heart disease. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sustained virological response measured by HEV RNA | HEV RNA undetectable at 48 weeks after end of treatment | 48 weeks |
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