Chronic Hepatitis E MedDRA version: 18.0 Level: PT Classification code 10019768 Term: Hepatitis E System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Ribavirina Normon
Pharmaceutical Form: Tablet
INN or Proposed INN: Ribavirina
Other descriptive name: RIBAVIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Fundació Hospital Vall Hebron Institut de Recerca
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy assessment (sustained virologic response rate) with Ribavirina in two therapeutic strategies with ribavirina in patients with chronic hepatitis E and severe acute.;Primary end point(s): Sustained virological response ( HEV RNA undetectable at 48 weeks after completion of treatment ) .;Timepoint(s) of evaluation of this end point: At 48 weeks after treatment ends .;Secondary Objective: - To define the recidiva real rate of the chronic hepatitis by a prospective 12 months trial. - Validation of Fibroscan as diagnostic test for the fibrosis in the chronic hepatitis E. - Identification of risk factors associated with chronic hepatitis E ( type of immunosuppression , analytical data , epidemiological factors ... ) . - To reduce costs derived from the control of the symptomatic hemolytic anemia in patients under treatment by the adjustment of Ribavirina's plasmatic levels and hemoglobin. - Study of the possible mutagenic effect of ribavirin in patients with chronic hepatitis E. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Virological response at the end of treatment ( RNA undetectable at end of treatment with ribavirin HEV) . - Ribavirin dose titration according to drug plasma levels. Ribavirin plasma levels of each patient were recorded every 4 weeks;Timepoint(s) of evaluation of this end point: - 12 or 24 weeks depending on the group . - Every 4 weeks | — |
Countries
Spain
Contacts
Public ContactServicio Hepatología
Fundación Hospital Vall Hebron Institut de Recerca
Outcome results
None listed