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

This study has been terminated.
(This study was terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686881
First received: May 27, 2008
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Biological: Peginterferon alfa-2b (PegIFN-2b)
Drug: Comparator: Stronger neo minophagen C (SNMC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Change in Metavir Fibrosis Score [ Time Frame: Baseline and discontinuation of treatment (up to 156 weeks) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.

  • Number of Participants With Change in Metavir Inflammation Score [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    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).


Enrollment: 261
Study Start Date: December 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686881     History of Changes
Other Study ID Numbers: P04773, JPC-05-356-30
Study First Received: May 27, 2008
Results First Received: February 3, 2012
Last Updated: September 26, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Glycine
Glycyrrhetinic Acid
Interferon-alpha
Interferons
Peginterferon alfa-2b
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antiviral Agents
Glycine Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014