Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)

NCT00686881 | Terminated Phase 3 Results DMC

• 2 other identifiers: P04773JPC-05-356-30
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Change in Metavir Fibrosis Score

  Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).

  Baseline and discontinuation of treatment (up to 156 weeks)

Secondary Outcomes (2)

• Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration

  Week 24

• Number of Participants With Change in Metavir Inflammation Score

  Baseline and Week 48

Study Arms (2)

PegIFN-2b

EXPERIMENTAL

Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.

Biological: Peginterferon alfa-2b (PegIFN-2b)

SNMC

ACTIVE COMPARATOR

Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.

Drug: Comparator: Stronger neo minophagen C (SNMC)

Interventions

Peginterferon alfa-2b (PegIFN-2b) BIOLOGICAL

PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks

Also known as: SCH 054031, Pegylated interferon alfa-2b

PegIFN-2b

Comparator: Stronger neo minophagen C (SNMC) DRUG

SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

SNMC

Eligibility Criteria

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

You may qualify if:

• Patients with chronic hepatitis C previously treated with interferon
• At least 20 years of age
• Liver fibrosis score rated as F2 or F3 based on the result of liver biopsy at screening
• Female patients willing to use contraception
• Body weight from 35.0 kg to 110.0 kg (inclusive)
• Positive for hepatitis C virus ribonucleic acid (HCV-RNA) by qualitative assay
• Patients who meet the following laboratory criteria:
• Serum alanine aminotransferase (ALT) level: \>60 IU/L
• Neutrophil count: \>=1,200/mm\^3
• Platelet count: \>=100,000/mm\^3
• Serum potassium level: \>=3.5 mEq/L

You may not qualify if:

• Patients who received interferon therapy within 90 days of Screening
• Patients who have received antiviral agents or antitumor agents, or immunomodulator therapy (including chronic glucocorticoids and radiotherapy) within 90 days of Screening (excluding local administration and topical use)
• Patients who have received other investigational drugs within 90 days of Screening
• Hepatitis B surface antigen (HBs)positive
• Antinuclear antibody titer of 1:320 or higher
• Creatinine level exceeding the upper limit of the reference range measured at screening test 2;
• Fasting blood glucose level of \>=126 mg/dL
• Patients on insulin therapy regardless of the fasting blood glucose level
• Patients who have a concurrent or past history of any of the following conditions: liver cirrhosis, liver failure, or liver carcinoma; hepatic encephalopathy, esophageal varices requiring treatment, or ascites; suicidal attempt or ideation; epileptic seizures requiring drug therapy; angina pectoris, heart failure, myocardial infarction or fatal arrhythmia; autoimmune disease (Hashimoto's disease \[chronic thyroiditis\], Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc.); malignant tumors (it is permitted to register patients with at least 5 years after cure).
• Patients who concurrently have any of the following conditions: liver disease such as autoimmune hepatitis, alcoholic liver injury, and drug-induced hepatitis; hemophilia; depression or schizophrenia which requires treatment; hypertension which cannot be controlled by drug therapy or arrhythmia which requires treatment, chronic pulmonary disease; abnormal thyroid function that cannot be controlled by drug therapy; organ transplants (other than corneal, hair transplant, etc.); aldosteronism, myopathy, or hypokalemia.
• Patients with a history of hypersensitivity to interferon preparations or biological products such as vaccines
• Patients with a history of hypersensitivity to monoammonium glycyrrhizinate, glycine, or L-cysteine monohydrochloride;
• Women who are pregnant or lactating, and women in whom pregnancy cannot be ruled out based on the result of serum human chorionic gonadotropin (HCG) measurement at Screening

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was prematurely discontinued because of low enrollment.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp..

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 27, 2008
• First Posted: May 30, 2008
• Study Start: December 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 6, 2017
• Results First Posted: March 6, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share