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: April 29, 2014
Last verified: April 2014

May 27, 2008
April 29, 2014
December 2006
February 2011   (final data collection date for primary outcome measure)
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).
Inhibition of liver fibrosis progression at the end of the treatment period [ Time Frame: At the end of the treatment period: (1) at Week 156 from the start of treatment; or (2) at discontinuation. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00686881 on ClinicalTrials.gov Archive Site
  • 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).
  • Improvement in hepatic enzymes [ Time Frame: At Week 24 from the start of treatment ] [ Designated as safety issue: No ]
  • Improvement in liver inflammation [ Time Frame: At Week 48 from the start of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • 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
  • 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 .
  • Experimental: PegIFN-2b
    Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
    Intervention: Biological: Peginterferon alfa-2b (PegIFN-2b)
  • Active Comparator: SNMC
    Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
    Intervention: Drug: Comparator: Stronger neo minophagen C (SNMC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
261
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00686881
P04773, JPC-05-356-30
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP