CHRONIC HEPATITIS C
Conditions
Interventions
Trade Name: Pegasys 180 mcg
Product Name: Peginterferon alfa 2a
Product Code: EU/1/02/221/0010
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
Concentration unit
Sponsors
Vicente Soriano-Hospital Carlos III. Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults patients age from 18 to 65 anti HCV positive (ELISA) RNA HCV positive HIV positive relapser patient to interferon therapy lymfocytes CD4+ >200 cel/hl anti HBsAg negative compensate hepatopathy 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pregnancy woman HBV HIV treatment with ddI alcoholic hepatitis hepatoma depresion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the treatment with peginterferon alfa 2a (40KD) in combination with ribavirin in co infected HIV-HCV patients after previous interferon treatments.;Secondary Objective: To evaluate the safety;Primary end point(s): Percentage of patients with HCV-RNA undetectable at week 72 of the study. 24 weeks after the end of the treatment period. | — |
Countries
Spain
Outcome results
None listed