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)
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)
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.
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)