Treatment of Patients with Chronic Hepatitis C who are Non-responders to a course with approved doses of PEGinterferon alpha + Ribavirin MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ZADAXIN*1FL LIOF 1,6MG/ML+F1ML
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: VARI
CAS Number: 62304-98-7
Concentration unit: mg milligram(s)
Conce
Sponsors
SIGMA-TAU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: 0 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the purpose of this trial is to determine safety and efficacy of 48 weeks treatment with thymosin alpha 1 in combination with PEGinterferon alfa-2a and ribavirin in adult patients with chronic hepatitis C (HCV) already treated with, and not responding to one course of PEGinterferon alfa plus ribavirin combination therapy, in comparison with a concurrent group treated with PEGinterferon alfa-2a in combination with ribavirin and placebo. The definition of ''non-responder'' for this study applies to all the patients who did not show a reduction > o = log^10 in HCV RNA by quantitative PCR after at least 12 weeks of therapy or all patients who did not show a virological response (i.e. viral RNA clearance) after a course of at least 24 weeks of therapy (PCR qualitative).;Secondary Objective: ;Primary end point(s): | — |
Countries
Germany, Italy, Spain
Outcome results
None listed