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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02558114 |
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Date of registration:
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18/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.
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Scientific title:
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Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02558114 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis E
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Intervention(s)
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Drug: Ribavirin
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Primary Outcome(s)
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Sustained virological response measured by HEV RNA
[Time Frame: 48 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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