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

March 8, 2017 updated by: Merck Sharp & Dohme LLC

A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PegIFN-2b
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)
PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks
Other Names:
  • SCH 054031
  • Pegylated interferon alfa-2b
ACTIVE_COMPARATOR: SNMC
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)
SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Change in Metavir Fibrosis Score
Time Frame: Baseline and discontinuation of treatment (up to 156 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
Time Frame: Week 24
The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
Week 24
Number of Participants With Change in Metavir Inflammation Score
Time Frame: Baseline and Week 48
Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).
Baseline and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

May 30, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04773
  • JPC-05-356-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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