Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-extended Versus 24-week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan
PegIntron (peginterferon alfa-2b; SCH 54031)
+ Ribavirin
Blood-Borne Infections+14
+ Chronic Disease
+ Communicable Diseases
Treatment Study
Summary
Study start date: March 1, 2005
Actual date on which the first participant was enrolled.This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which all subjects should participate in the Pilot Treatment Program and complete 24 weeks treatment. To avoid a treatment gap, subjects who will be screened and eligible subjects will sign informed consent prior to the end of the Pilot Treatment Program. After completion of the Pilot Treatment Program, all eligible subjects will be randomly assigned to either study group. Subjects in the 24-Week Treatment arm will be followed-up without study medication for 48 weeks; subjects in the 48-Week Treatment arm will be continuously treated for another 24 weeks and all subjects in the 48-Week Treatment arm will be followed for another 24 weeks after completion of the treatment period. Subjects in both arms will be evaluated at screening, randomization, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks after randomization.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules. * Males and non-pregnant females and aged \>= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry. * The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria: * Hemoglobin values of \>= 12 g/dL for females and \>= 13 g/dL for males * Neutrophil count \>= 1.5 X10\^9/L * Platelets count \>= 100 x 10\^9/L * Total bilirubin \< 1.5 mg/dL * Serum creatinine within normal limits * Positive serum HCV-RNA (\>= 50 IU (100 copy numbers)/mL) * Anti-HCV positive * Available HCV genotype 1 * Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system \>=F1). * Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit: * Hemoglobin values of \>= 9 g/dL * Neutrophil count \>= 0.75 x 10\^9/L * Platelets count \>= 50 x 10\^9/L * Prothrombin time (PT) prolong \<= 3 sec, International Normalized Ratio (INR) \<= 1.2 * Total bilirubin \<= 3 mg/dL * Within normal limits (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met). * Anti-Human Immunodeficiency Virus (HIV) negative. * Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but \<= 50 ng/mL require both of the following: * AFP value \<= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma. * A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding. * Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period. * Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin. * Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program. * The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage. Exclusion Criteria: * Women who are pregnant or nursing. * Have decompensated cirrhosis. * History of severe psychiatric disease, especially depression. * Concurrent malignancies (including hepatocellular carcinoma). * Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities. * Prolonged exposure to known hepatotoxins such as alcohol or drugs. * History of thyroid disease poorly controlled on prescribed medication. * Poorly controlled diabetes mellitus. * Has suspected or confirmed significant hepatic disease from an etiology other than HCV. * Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV). * Severe renal disease or myeloid dysfunction. * History of organ transplantation other than cornea and hair transplant. * Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. * Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol. * Allergy to interferon.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives