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)

NCT03537274 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C97010MK-4031-016
• Study Type: interventional
• Target: 1,224
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Achieving Responder Status at 24 Weeks of Treatment

  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

  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)

Study Arms (4)

PEG-Intron, 0.5 mg/kg

EXPERIMENTAL

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

Biological: PEG-Intron

PEG-Intron, 1.0 mg/kg

EXPERIMENTAL

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

Biological: PEG-Intron

PEG-Intron, 1.5 mg/kg

EXPERIMENTAL

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

Biological: PEG-Intron

Interferon Alfa-2b

ACTIVE COMPARATOR

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

Interventions

PEG-Intron 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.

Also known as: SCH 54031

PEG-Intron, 0.5 mg/kg; PEG-Intron, 1.0 mg/kg; PEG-Intron, 1.5 mg/kg

Interferon Alfa-2B BIOLOGICAL

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

Interferon Alfa-2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2b; Interferon alpha-2

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 21.0

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: August 5, 1997
• Primary Completion: July 23, 1999
• Study Completion: July 23, 1999
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-01