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Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116) | Clinical Trials | Clareo Health

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Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)

Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin

NCT00687219•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults aged 20-70 years.
•Positive quantitative serum HCV-RNA.
•Participants classified as A in Child-Pugh classification, and who do not have ascites or hepatic encephalopathy.
•Diagnosed with type C compensated liver cirrhosis based on liver biopsy performed within 3 years or latest celioscopy.
•Prolonged prothrombin time by \<=3.0 sec.
•Participants and partners of participants willing to use adequate contraception during the course of the study.
•Participants who can be hospitalized for at least 14 days since treatment initiation.
•Weight \>40 kg and \<=100 kg
•Hematology laboratory results of:
•* hemoglobin \>=12 g/dL
+7 more criteria

Exclusion Criteria

•Participants who did not previously respond virologically to combination therapy with interferon (including polyethylene glycol-modified interferon) and ribavirin
•Participants who had previously received treatment with interferon for whom at least 90 days have not elapsed since the end of previous treatment
•Participants who have received treatment within 14 days prior to registration with injectable preparations containing glycyrrhizin/cysteine/glycyron or shosaikoto
•Participants who have received administration of drugs having antiviral, anti-tumor, or immuno-modulating effect (including glucocorticoids and radiation therapy) within 90 days prior to registration (excluding local administration and topicals)
•Participants who have received other investigational drugs within 180 days prior to registration
•Hepatitis B surface (HBs) antigen positive
•Antinuclear antibody \>=320 times
•Serum creatinine exceeding the upper limit of reference range
•Participants with fasting blood glucose \>=110 mg/dL (participants with fasting blood glucose \>=110 mg/dL and \<126 mg/dL can be registered if their hemoglobin A1C (HbA1c) is \<6.5%) \[fasting blood glucose should be measured when participants are not receiving treatment for diabetes mellitus\]
•Participants with any of the following: diabetes mellitus that requires treatment; thyroid function disorder not controlled by treatment; liver disease such as autoimmune, alcoholic and drug-induced liver diseases; hemophilia; arrhythmia requiring treatment; co-existing hypertension not controlled by drug therapy (systolic blood pressure \[BP\] \>=160mmHg or diastolic BP\>=100mmHg); chronic pulmonary disease; hemoglobinopathies (thalassemia, sickle cell anemia); malignant tumors or who have a history of malignant tumor within the past 5 years; organ transplants (other than cornea and hair transplant)
+3 more criteria

Key Dates

Start Date

June 1, 2007

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

April 7, 2017

Enrollment

102

ACTUAL participants

Conditions

Hepatitis C, ChronicLiver Cirrhosis

Interventions

Peginterferon alfa-2b

BIOLOGICAL

Ribavirin

DRUG

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

NCT06169592

Liver CirrhosisLiver Transplant; Complications

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RECRUITING

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

NCT07275554

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)

Inclusion Criteria

Exclusion Criteria

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

DOAC in Patients with Child a or B Liver Cirrhosis

Role of Nutritional Intervention for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome