Status:
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00686777
Start Date
January 1 2008
End Date
December 1 2010
Last Update
April 7 2017
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