Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)

NCT00811967 | Terminated Phase 3

• 2 other identifiers: P03811JPC-02-320-34
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and enter Follow-up.

Conditions

Hepatitis C, Chronic; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response rate, defined as the proportion of subjects with undetectable HCV-RNA at 24-week post-treatment follow-up

  Measured at 24 weeks post-treatment

Secondary Outcomes (1)

• Rate of subject with undetectable HCV-RNA at the end of treatment (or at discontinuation of treatment)

  Measured at the end of treatment (or at discontinuation of treatment)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

Control Arm

NO INTERVENTION

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) BIOLOGICAL

PegIntron administered at a dose of 1.5 ug/kg QW SC for up to 48 weeks

Also known as: SCH 54031

Treatment Arm

Rebetol (ribavirin; SCH 18908) DRUG

Rebetol administered at a dose of 600, 800, or 1000 mg/day, orally, for up to 48 weeks.

Also known as: SCH 18908

Treatment Arm

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients (regardless of gender) who can take contraceptive measures from date of informed consent to the end of follow-up
• Patients who meet all the criteria below in the test/observation/ investigation in 30 days before the beginning of treatment.
• Patients with quantitative HCV-RNA (+)
• ALT \> 40 IU/L
• Patients who are classified as Child-Pugh Classification A, and who do not have ascites or hepatic encephalopathy
• Prothrombin Time \<=3.0 seconds prolonged, total bilirubin \<= 1.5 mg/dL or direct bilirubin \<= 0.7 mg/dL, Albumin \>= 3.0 g/dL
• AFP within normal limits, AFP-L3 \<= 10%，PIVKA-II \<= 100 mAU/mL
• Serum creatinine \<= upper limit of normal, creatinine clearance \>= 51 mL/minute
• Patients with fasting blood glucose \< 110 mg/dL.
• Thyroid-stimulating hormone within normal limits
• Hemoglobin level \>= 12 g/dL，leukocyte count \>= 3,000/mm3，neutrophil count \>= 1,500 /mm3，platelet count \>= 80,000/mm3
• Patients who weighs more than 40 kg and not more than 100 kg within 60 days prior to registration
• Patients who were diagnosed with liver cirrhosis (fibrosis score: F4) based on the liver biopsy performed within a year prior to registration and is able to provide with liver tissue sample.
• Patients who between the ages of 20 and 70 years at time of informed consent who can give written informed consent
• Patients who can be hospitalized at least for 14 days from the initiation of treatment.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Cirrhosis

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: February 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: March 13, 2017

Record last verified: 2017-03