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

Tracking Information
First Submitted Date ICMJE	May 27, 2008
First Posted Date ICMJE	May 30, 2008
Results First Submitted Date	February 3, 2012
Results First Posted Date	March 6, 2012
Last Update Posted Date	April 6, 2017
Study Start Date ICMJE	December 2006
Actual Primary Completion Date	February 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 3, 2012)	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).
Original Primary Outcome Measures ICMJE; (submitted: May 29, 2008)	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. ]
Change History	Complete list of historical versions of study NCT00686881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 3, 2012)	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.; 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).
Original Secondary Outcome Measures ICMJE; (submitted: May 29, 2008)	Improvement in hepatic enzymes [ Time Frame: At Week 24 from the start of treatment ]; Improvement in liver inflammation [ Time Frame: At Week 48 from the start of treatment ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
Official Title ICMJE	A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hepatitis C, Chronic
Intervention ICMJE	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 .
Study Arms	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 10, 2011)	261
Original Estimated Enrollment ICMJE; (submitted: May 29, 2008)	500
Actual Study Completion Date	February 2011
Actual Primary Completion Date	February 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Japan
Administrative Information
NCT Number ICMJE	NCT00686881
Other Study ID Numbers ICMJE	P04773; JPC-05-356-30
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes 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
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP