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)

NCT ID: NCT03537274

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-08-05
• Study Completion Date: 1999-07-23

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PEG-Intron, 0.5 mg/kg

PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection.

Group Type: EXPERIMENTAL

PEG-Intron

Intervention Type: BIOLOGICAL

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.

PEG-Intron, 1.0 mg/kg

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

Group Type: EXPERIMENTAL

PEG-Intron

Intervention Type: BIOLOGICAL

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.

PEG-Intron, 1.5 mg/kg

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

Group Type: EXPERIMENTAL

PEG-Intron

Intervention Type: BIOLOGICAL

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.

Interferon Alfa-2b

Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection.

Group Type: ACTIVE_COMPARATOR

Interferon Alfa-2B

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

Interferon Alfa-2B

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

Intervention Type: BIOLOGICAL

Other Intervention Names

SCH 54031

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-4031-016

Identifier Type: OTHER

Identifier Source: secondary_id

C97010

Identifier Type: OTHER

Identifier Source: secondary_id

C97010

Identifier Type: -

Identifier Source: org_study_id