Phase 3
N=102
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
Hepatitis C, Chronic · Liver Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT00687219 ↗Enrolled (actual)
102
Serious AEs
13.7%
Results posted
Dec 2011
Primary outcome: Primary: Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response) — 41; 40; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Peginterferon alfa-2b (Biological); Ribavirin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response) |
41; 40; 21 | — |
| SECONDARY Number of Participants With Undetectable HCV-RNA at Week 24 |
61; 35; 6 | — |
| SECONDARY Number of Participants With Undetectable HCV-RNA at End of Treatment |
59; 43; 0 | — |
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 Criteria
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 40 kg and =12 g/dL
- neutrophil count >=1,500/mm^3
- platelet count >=70,000/ mm^3
- Blood chemistry results of:
- albumin and direct bilirubin within normal limits
- alpha fetoprotein (AFP) within reference range
- AFP-L3 =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 =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)
- Participants with or who have a history of primary biliary cirrhosis, liver failure, hepatic carcinoma; decompensated liver cirrhosis with any the following diseases: ascites, jaundice, variceal hemorrhage, esophageal or gastric varices requiring treatment, hepatic encephalopathy, and idiopathic bacterial peritonitis; depression or schizophrenia requiring treatment, or suicidal attempt or suicidal ideation; epileptic seizures requiring treatment; angina, cardiac failure, myocardial infarction, or life-threatening arrhythmia; autoimmune disease (Hashimoto's disease, Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic erythematosus, autoimmune hemolytic anemia, scleroderma, etc.); hepatic carcinoma
- Participants with a history of hypersensitivity to interferon preparations, biological products such as vaccine, or nucleoside analogs, and those with specific reaction to pegylated interferon alfa-2b in the prick test conducted before the initiation of treatment
- Women who are pregnant or nursing as well as women for whom pregnancy cannot be ruled out by serum human chorionic gonadotropin (HCG) test conducted during the screening period. Male participants with partners who are pregnant.
Data sourced from ClinicalTrials.gov (NCT00687219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.