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Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

NCT02558114 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-04-16

No results posted yet for this study

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.

Conditions

  • Hepatitis E

Interventions

DRUG

Ribavirin

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02558114 on ClinicalTrials.gov