Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

NCT02558114 | Terminated Phase 4

• 1 other identifier: RACHE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis E

Outcome Measures

Primary Outcomes (1)

• Sustained virological response measured by HEV RNA

  HEV RNA undetectable at 48 weeks after end of treatment

  48 weeks

Study Arms (2)

Group A

OTHER

Patients will receive ribavirin during 12 weeks

Drug: Ribavirin

Group B

OTHER

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

Interventions

Ribavirin DRUG

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Hepatitis E

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 23, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

ES (1)