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)

Conditions: Hepatitis C, Chronic

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)

Keywords: hepatitis c