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Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)

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ClinicalTrials.gov Identifier: NCT03537274
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Results First Submitted Date  ICMJE January 10, 2019
Results First Posted Date  ICMJE April 9, 2019
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE August 5, 1997
Actual Primary Completion Date July 23, 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Number of Participants Achieving Responder Status at 24 Weeks of Treatment [ Time Frame: Up to 24 weeks ]
    The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as <100 copies/mL serum by quantitative polymerase chain reaction [qPCR] assay); and 2) alanine transaminase (ALT) level normal.
  • Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up [ Time Frame: Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up) ]
    The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as <100 copies/mL serum by qPCR assay); and 2) ALT level normal.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Number of Participants Achieving HCV-RNA Negative (<100 copies/mL serum) and Alanine Transaminase (ALT) Normal at 24 Weeks of Treatment [ Time Frame: Up to 24 weeks ]
  • Number of Participants Achieving HCV-RNA Negative (<100 copies/mL serum) and Alanine Transaminase (ALT) Normal at 24 Weeks Follow-up [ Time Frame: Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)
Official Title  ICMJE Comparison of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) vs. Interferon Alfa-2B for Treatment of Adult Subjects With Chronic Hepatitis C Not Previously Treated With Interferon: Dose Finding Study
Brief Summary This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon. Participants are randomized to receive one of three doses of PEG-Intron (0.5, 1.0, and 1.5 mg/kg) or Interferon Alfa-2B for 48 weeks. The primary objective of this study is to evaluate the efficacy of PEG-Intron (compared to Interferon Alfa-2B) with respect to response based on loss of detectable HCV ribonucleic acid (HCV-RNA) and normalization of alanine transaminase (ALT) level after 24 weeks of therapy and at 24 weeks of follow-up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Biological: PEG-Intron
    PEG-Intron is administered QW for 48 weeks by SC injection at 0.5, 1.0, and 1.5 mg/kg body weight. Body weight obtained at the baseline visit is used to calculate dosing.
    Other Name: SCH 54031
  • Biological: Interferon Alfa-2B
    Interferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight.
Study Arms  ICMJE
  • Experimental: PEG-Intron, 0.5 mg/kg
    PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection.
    Intervention: Biological: PEG-Intron
  • Experimental: PEG-Intron, 1.0 mg/kg
    PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
    Intervention: Biological: PEG-Intron
  • Experimental: PEG-Intron, 1.5 mg/kg
    PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
    Intervention: Biological: PEG-Intron
  • Active Comparator: Interferon Alfa-2b
    Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection.
    Intervention: Biological: Interferon Alfa-2B
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2018)
1224
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 23, 1999
Actual Primary Completion Date July 23, 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be serum positive for hepatitis C virus.
  • Have liver biopsy within 1 year prior to entry, with a pathology report confirming a histological diagnosis consistent with chronic hepatitis.
  • Have one abnormal historic ALT at least 6 months prior to screening, with elevated ALT at entry.
  • Have compensated liver disease, testing negative for HIV and serum hepatitis B surface antigen (HBsAg) at entry.
  • If male or female of childbearing potential, be practicing adequate contraception during treatment.

Exclusion Criteria:

  • Be female who is currently pregnant or nursing.
  • Have prior treatment with any interferon.
  • Have suspected hypersensitivity to alpha interferon.
  • Have participated in any other clinical trial within 30 days of entry
  • Have received treatment with any investigational drug within 30 days of entry.
  • Have received prior treatment for hepatitis with any other antiviral or immunomodulatory drug within the previous 2 years.
  • Have any other cause for the liver disease other than chronic hepatitis C including but not limited to: co-infection with hepatitis B virus; Hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease; and drug-related liver disease.
  • Have hemophilia or any other condition that would prevent the participant from having a liver biopsy, including anticoagulant therapy.
  • Have hemoglobinopathies (e.g., Thalassemia)
  • Have evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.
  • Have received organ transplants.
  • Have a preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or attempt.
  • Have central nervous system trauma or active seizure disorders requiring medication.
  • Have significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia).
  • Have poorly controlled diabetes mellitus.
  • Have chronic pulmonary disease (e.g., chronic obstructive pulmonary disease).
  • Have immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis).
  • Have any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
  • Have history of substance abuse, such as alcohol, intravenous drugs and inhaled drugs.
  • Have clinically significant retinal abnormalities.
  • Be unable to abstain from the consumption of alcohol.
  • Have any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537274
Other Study ID Numbers  ICMJE C97010
MK-4031-016 ( Other Identifier: Merck Protocol Number )
C97010 ( Other Identifier: Schering-Plough Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date January 2019

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