Two treatment strategies with Ribavirin for Chronic Hepatitis E and severe acute forms randomized study

Phase 1

• Conditions: Chronic Hepatitis E; MedDRA version: 18.0Level: PTClassification code 10019768Term: Hepatitis ESystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000699-91-ES
• Lead Sponsor: Fundació Hospital Vall Hebron Institut de Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

- 18 years old or above.
- That meet one of the following two diagnostics:
a) 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 by an interval of six months determinations.
b) Severe acute hepatitis E: ALT levels greater than 10 times the normal limit , HEV RNA positive , and signs of acute liver injury (INR > 1.5) ; or extrahepatic manifestations or liver failure in patients with previous liver disease.
- Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Terminal illness with a life expectancy of less than six months.
- Patients with contraindications for treatment with Ribavirin :
a) Pregnancy or breastfeeding
b) Hepatic serious insufficiency or unbalanced cirrhosis.
c) Hemoglobinopathies ( thalassemia , sickle cell anemia ) .
d) History of severe pre-existing cardiac disease , including unstable heart disease .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified