Back to resultsRibavirin for Severe Acute and Chronic Hepatitis E Virus Infection.
Primary Purpose
Hepatitis E
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis E
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
Patients will receive ribavirin during 12 weeks
Patients will receive: ribavirin during 12 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is undetectable at week 4 after treatment start (adjust to renal function) - ribavirin during 24 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is detectable at week 4 after treatment start (adjust to renal function)
Outcomes
Primary Outcome Measures
Sustained virological response measured by HEV RNA
HEV RNA undetectable at 48 weeks after end of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02558114
First Posted
September 18, 2015
Last Updated
April 15, 2019
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02558114
Brief Title
Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.
Official Title
Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
December 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis E
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
Patients will receive ribavirin during 12 weeks
Arm Title
Group B
Arm Type
Other
Arm Description
Patients will receive:
ribavirin during 12 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is undetectable at week 4 after treatment start (adjust to renal function)
- ribavirin during 24 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is detectable at week 4 after treatment start (adjust to renal function)
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Primary Outcome Measure Information:
Title
Sustained virological response measured by HEV RNA
Description
HEV RNA undetectable at 48 weeks after end of treatment
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitari vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.
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