C hepatitis MedDRA version: 14.1 Level: PT Classification code 10019755 Term: Hepatitis chronic active System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: Tarceva 25mg comprimés pelliculés
Pharmaceutical Form: Capsule
INN or Proposed INN: ERLOTINIB HYDROCHLORIDE
CAS Number: 183319-69-9
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluating short term efficacy and safety of erlotinib in patient infected with genotype 1 C hepatitis virus ;Secondary Objective: - assessement of viral kinetic - erlotinib phamacokinitic evaluation - functional analysis of HCV quasispecies and viral resistance evaluation ;Primary end point(s): | — |
Countries
France
Contacts
Public ContactProject Manager
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed