Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

Hepatitis E Clinical Trial

Official title:

Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02558114
• Other study ID #: RACHE
• Status: Terminated
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E
• Hepatitis, Chronic

Intervention

Drug:
• Ribavirin

Locations

Country	Name	City	State
Spain	Hospital Universitari vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response measured by HEV RNA	HEV RNA undetectable at 48 weeks after end of treatment	48 weeks