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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.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Biological: PEG-Intron Biological: Interferon Alfa-2B Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 1997
Actual Primary Completion Date : July 23, 1999
Actual Study Completion Date : July 23, 1999


Arm Intervention/treatment
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.
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

Experimental: PEG-Intron, 1.0 mg/kg
PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
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

Experimental: PEG-Intron, 1.5 mg/kg
PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
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

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.
Biological: Interferon Alfa-2B
Interferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537274


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03537274     History of Changes
Other Study ID Numbers: C97010
MK-4031-016 ( Other Identifier: Merck Protocol Number )
C97010 ( Other Identifier: Schering-Plough Protocol Number )
First Posted: May 25, 2018    Key Record Dates
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs