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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): PegIntron (peginterferon alfa-2b; SCH 54031); PegIntron (peginterferon alfa-2b; SCH 54031); Ribavirin; Ribavirin
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): 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
Other intervention name(s): peginterferon alfa-2b; SCH 54031; peginterferon alfa-2b; SCH 54031; SCH 18908; SCH 18908
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment