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)

January 10, 2019 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1224

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 weeks
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.
Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 5, 1997

Primary Completion (ACTUAL)

July 23, 1999

Study Completion (ACTUAL)

July 23, 1999

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (ACTUAL)

May 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C97010 (OTHER: Schering-Plough Protocol Number)
  • MK-4031-016 (OTHER: Merck Protocol Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on PEG-Intron

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe