Status:
TERMINATED
Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin
Lead Sponsor:
Göteborg University
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection...
Eligibility Criteria
Inclusion
- 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 2 or/and 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period
- Previous relapse (i.e. HCV-RNA \< 50 IU/mL at end of previous therapy) after one treatment period with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
- A minimum of 24 weeks must have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period before the patients can be included in this study
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Patients with suspected 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 the 6 months after treatment end
- Having a liver biopsy obtained within 5 years of this study is encouraged, but optional in accordance with local treatment traditions.
Exclusion
- Women with ongoing pregnancy or breast feeding
- Previous non-response during treatment (as defined as having detectable HCV RNA ≥ 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
- Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study.
- Therapy with any systemic anti-viral
- anti-neoplastic
- immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤ 6 months prior to the first dose of study drug
- Any investigational drug ≤ 6 weeks prior to the first dose of study drug. HCV genotype 1, 4, 5 or 6 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 \< 75,000 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
- 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. (Patients receiving Methadone or Subutex therapy may be included in this study.)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Hemoglobin \< 11.3 g/dL (\< 7.0 mmol/L) in women or \< 12.9 g/dL (\< 8.0 mmol/L) in men at screening.
- Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, etc) or for whom anemia would be medically problematic
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00641654
Start Date
January 1 2007
End Date
December 1 2009
Last Update
August 30 2012
Active Locations (1)
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1
Dept of Infectious Diseases, Sahlgrenska University Hospital
Gothenburg, Sweden, SE-416 85