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)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: May 27, 2008
Last updated: October 31, 2014
Last verified: October 2014
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.
Hepatitis C, Chronic
Biological: Pegylated Interferon alfa-2b
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Low Dose Treatment of Ribavirin in Combination With PEG-IFN Alfa-2b in CHC Patients With genotype1 High Viral Load and Low Body Weight
Primary Outcome Measures:
- Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation [ Time Frame: Measured at 24 weeks after the end of treatment (at the end of follow-up) ] [ Designated as safety issue: No ]
SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.
HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
- Number of Participants Discontinuing Treatment [ Time Frame: From time of first treatment to Week 48 ] [ Designated as safety issue: Yes ]
Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
Experimental: 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.
Biological: Pegylated Interferon alfa-2b
Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks
Other Name: SCH 54031
Ribavirin 400 mg/day orally
Other Name: SCH 18908
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 27, 2008
|Results First Received:
||December 12, 2011
||October 31, 2014
||Japan: Pharmaceuticals and Medical Devices Agency
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 30, 2015
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs