A Randomized, Open-label, Parallel Group, Multicenter Pilot Study Evaluating the Efficacy and Safety of Alternative Dosing of Ribavirin vs. Standard of Care Dosing in Combination with Peginterferon alpha-2a in Interferon Naïve Patients with Chronic Hepatitis C Genotype 1 Infection - RibaC

Phase 1

Conditions: Chronic hepatitis C infection
MedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

Registration Number: EUCTR2010-018332-41-DK

Lead Sponsor: Dept. of Infectious diseases / virology University of Gothenburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

•Written informed consent
•Male and female patients >/=18 years of age
•Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
•Serum HCV-RNA >/=15 IU/mL.
•HCV genotype 1 infection confirmed within the past 2 years preceding the initiation of test drug dosing.
•Compensated liver disease (Child-Pugh Grade A clinical classification)
•Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP =100 ng/mL within 2 months of randomization
•Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
•All fertile males and females receiving ribavirin must be using effective contraception during treatment and during 4 months for female patients / 7 months for male patients after end of treatment
•Subject must weigh between 45 and 105 kg at screening

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Women with ongoing pregnancy or breast feeding
•IFN/ peg-interferon with or without ribavirin therapy at any previous time
•Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
•Any investigational drug •HCV genotype 2, 3, 4, 5, 6, or 7 infection.
•Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
•Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
•History or other evidence of decompensated liver disease
•Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
•Serum creatinine level >2 mg/dl (>124 µmol/L) or creatinine clearance =50 ml/minute at screening
•Severe psychiatric disease, especially depression, as judged by the treating physician.
•History of a severe seizure disorder or current anticonvulsant use
•History of immunologically mediated disease, severe chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
•Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
•Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
•Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions.
•Inability or unwillingness to provide informed consent or abide by the requirements of the study
•Male partners of women who are pregnant
•Hemoglobin <12 g/dL in women or <13 g/dL in men at screening.
•Any patient with an increased baseline risk for anemia (e.g. thalassemia major, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic coagulopathy.
•Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated