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)

NCT ID: NCT00686777

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-12-31

Brief 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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-IFN + Ribavirin

Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.

Group Type: EXPERIMENTAL

Pegylated Interferon alfa-2b

Intervention Type: BIOLOGICAL

Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks

Ribavirin

Intervention Type: DRUG

Ribavirin 400 mg/day orally

Interventions

Pegylated Interferon alfa-2b

Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks

Intervention Type: BIOLOGICAL

Ribavirin

Ribavirin 400 mg/day orally

Intervention Type: DRUG

Other Intervention Names

SCH 54031; SCH 18908

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

JPC-06-320-40

Identifier Type: -

Identifier Source: secondary_id

P05172

Identifier Type: -

Identifier Source: org_study_id