Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Body Weight
Intervention: Pegylated Interferon alfa-2b; Ribavirin
Intervention description: Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks; Ribavirin 400 mg/day orally
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: hepatitis C

Summary:

      The objective is to evaluate the efficacy and safety of the combination therapy with
      subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose
      ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who
      are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with chronic hepatitis C.

          -  Minimum 20 years of age

          -  Willing to use adequate contraception during the course of the study.

          -  Participants who can be hospitalized for at least 14 days since treatment initiation.

          -  Positive for HCV genotype 1 (genotype 1a and 1b) with high viral load (HCV-RNA >=100
             kIU/mL).

          -  Participants weighing over 40 kg to 50 kg.

          -  Hematology results of:

               -  hemoglobin levels >=12 g/dL

               -  neutrophils >=1,500/mm^3

               -  platelets >=100,000/mm^3

        Exclusion Criteria:

          -  Previous ribavirin therapy.

          -  Previous interferon therapy within 90 days of registration.

          -  Participants who received treatment with injectable products containing
             glycyrrhizin/cysteine/glycine (Stronger Neo-Minophagen C, etc.), Shosaikoto, or
             ursodeoxycholic acid within 30 days before the start of treatment

          -  Participants who received treatment with an antiviral or anti-tumor drug or who
             received immunomodulating therapy (including steroids and radiotherapy) within 90 days
             before the start of treatment [excluding local administration and topical drugs].

          -  Participants who received other investigational drugs within 180 days before the start
             of treatment.

          -  Hepatitis Bs (HBs) antigen-positive

          -  Antinuclear antibodies >=1:160

          -  Fasting blood glucose >=110 mg/dL (however, participants with fasting blood glucose of
             110 mg/dL to <126 mg/dL can be registered if HbA1c is <6.5%)

          -  Participants diagnosed with liver cirrhosis in most recent celioscopy or liver biopsy.

          -  Participants with or who have a history of any of the following: liver failure;
             hepatic encephalopathy, esophageal varices, or ascites; depression or schizophrenia
             requiring treatment or suicidal attempt or ideation; epileptic seizures requiring drug
             treatment; autoimmune disease (such as Hashimoto's disease, Crohn's disease,
             ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura,
             systemic erythematosus, autoimmune hemolytic anemia, and scleroderma); hepatic cancer

          -  Participants with any of the following: liver disease such as autoimmune hepatitis,
             alcoholic liver disease, and drug-induced hepatic impairment; hemophilia; arrhythmia
             requiring treatment and participants with or who have a history of angina pectoris,
             cardiac failure, myocardial infarction, or life-threatening arrhythmia; hypertension
             (systolic BP of 160 mmHg or more and diastolic BP of 100 mmHg or more) not possible to
             control with drug therapy; chronic pulmonary disease; hemoglobinopathy (thalassemia,
             sickle cell anemia); malignant tumor or who have a history of malignant tumor within
             the past 5 years; thyroid function disorder not controlled by drug therapy.

          -  Participants with organ transplants (excluding cornea and hair transplants).

          -  Participants with a history of hypersensitivity to interferon preparations, nucleoside
             analogs, or biological products such as vaccine.

          -  Participants with a specific response to PEG-IFN alfa-2b in a prick test to be
             conducted just before the initiation of treatment.

          -  Participants who are pregnant or nursing (in the case of male Participants : partner
             is pregnant)