Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031); PegIntron (peginterferon alfa-2b; SCH 54031); Ribavirin; Ribavirin
Intervention description: Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program; Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program; 200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program; 200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open-label, randomized, comparative, multicenter, 48-week study designed to
      evaluate the efficacy and safety of combination treatment with pegylated interferon and
      ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C
      virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24
      weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects
      will be randomly assigned to one of two study groups. One group will be followed for an
      additional 48 weeks without study medication, while the other will be continuously treated
      for an additional 24 weeks and then followed for another 24 weeks without study medication.
      Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the
      follow-up period, will be measured along with other outcomes.
    

Eligibility 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.