Single arm prospective clinical study to evaluate the efficacy of combination therapy sofosbuvir+ribavirin+peg-interferon in experienced patients with HCV-GT1 - IN-US-334-0141 - SOF

AZIENDA OSPEDALIERA DI PADOVA0 个研究点开始时间: 2016年9月29日最近更新: 2016年10月3日

试验速览

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•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

•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).

发起方

AZIENDA OSPEDALIERA DI PADOVA