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Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT02558114
Collaborator
(none)
5
Enrollment
1
Location
2
Arms
35
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Group A

Patients will receive ribavirin during 12 weeks

Drug: Ribavirin
Other: Group B

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)

Drug: Ribavirin

Outcome Measures

Primary Outcome Measures

  1. Sustained virological response measured by HEV RNA [48 weeks]

    HEV RNA undetectable at 48 weeks after end of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitari vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT02558114
Other Study ID Numbers:
  • RACHE
First Posted:
Sep 23, 2015
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms:
Hepatitis A
Hepatitis E
Hepatitis
Ribavirin

Study Results

No Results Posted as of Apr 16, 2019