Single arm prospective clinical study to evaluate the efficacy of combination therapy sofosbuvir+ribavirin+peg-interferon in experienced patients with HCV-GT1

Phase 1

Conditions: chronic hepatitis HCV GT1 who have already failed a prior course of dual therapy with pegylated interferon + ribavirin
MedDRA version: 19.0Level: HLTClassification code 10057212Term: Hepatitis viral infectionsSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-005388-34-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI PADOVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Subjects, male or female, aged> 18 years.
2. Subjects infected with HCV genotype 1 chronic hepatitis or compensated cirrhosis (Child A).
3. Previous treatment with dual therapy (pegylated interferon + ribavirin) without obtaining SVR (relapsers, partial, null responders).
4. Positivity for serum HCV-RNA.
5. Evaluation recent (within 6 months) the degree of liver fibrosis with validated method (biopsy or Fibroscan).
6. Informed consent form with signed and dated
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. decompensated liver disease, or a history of heart failure, ascites, encephalopathy, HCC.
2. Inadequate tolerability ribavirin and/or pegylated interferon therapy during the previous attempt.
3. Any known contraindication to ribavirin and / or pegylated interferon and / or Sofosbuvir.
4. Any severe comorbidities that in the opinion of Clinical Researcher may compromise the safety of the treatment.
5. Pregnancy ongoing or breastfeeding. Pregnancy is highly NOT recommended in these patients, and if it is programmed patients are excluded from the study. If sexually active, patients should use an effective method of birth control.
6. Other concomitant treatment against viral hepatitis HCV.
7. Patients taking medications that interfere with ribavirin, pegylated interferon and Sofosbuvir (cytochrome P450, azathioprine, methadone, telbivudine and anti-HIV agents).