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)

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Biological: PEG-Intron; Biological: Interferon Alfa-2B

• Registration Number: NCT03537274
• Lead Sponsor: Merck Sharp & Dohme LLC

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 available

Study Timeline

• Study Start: 1997-08-05
• Primary Completion: 1999-07-23
• Study Completion: 1999-07-23
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Status Verified: 2019-01
• Results First Submitted: 2019-01-10
• Results First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Results First Posted: 2019-04-09
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-Intron, 1.0 mg/kg	PEG-Intron	PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
Interferon Alfa-2b	Interferon Alfa-2B	Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection.
PEG-Intron, 0.5 mg/kg	PEG-Intron	PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection.
PEG-Intron, 1.5 mg/kg	PEG-Intron	PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	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.
Number of Participants Achieving Responder Status at 24 Weeks of Treatment	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.