A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

NCT ID: NCT01641926

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-26
• Study Completion Date: 2016-01-21

Brief Summary

This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg] positive or negative) who have not previously been treated with interferon.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HBeAg(+) PEG-Intron

HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.

Group Type: EXPERIMENTAL

PEG-Intron™

Intervention Type: BIOLOGICAL

PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

HBeAg(+) PEGASYS

HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.

Group Type: ACTIVE_COMPARATOR

PEGASYS™

Intervention Type: BIOLOGICAL

PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

HBeAg(-) PEG-Intron

HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.

Group Type: EXPERIMENTAL

PEG-Intron™

Intervention Type: BIOLOGICAL

PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

HBeAG(-) PEGASYS

HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.

Group Type: ACTIVE_COMPARATOR

PEGASYS™

Intervention Type: BIOLOGICAL

PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

Interventions

PEG-Intron™

PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

Intervention Type: BIOLOGICAL

PEGASYS™

PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

SCH 054031; Pegylated interferon alfa-2b; Pegylated interferon alfa-2a

Eligibility Criteria

Inclusion Criteria

• Must be able to adhere to dose and visit schedules
• ≥ 40 kg
• Hepatitis B surface antigen (HBsAg) positive for at least 6 months
• Anti-HBs negative
• Female participants of childbearing potential must agree to use an acceptable

method of contraception from at least 2 weeks prior to Day 1 and continue until at least 1 month after last dose of study drug

• HBeAg(+)
• Anti-HBe(-)

• HBeAg(-)
• Anti-HBe(+)

Exclusion Criteria

• Co-infection with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis D virus
• Prior treatment with interferon for hepatitis B
• Use of nucleoside/nucleotide analogues within 6 months of the screening visit or at any time during the study
• Use of any investigational drug within 30 days of the screening visit
• Prior treatment with herbal remedies with known hepatotoxicity. All herbal remedies used for hepatitis B treatment must be discontinued before Day 1
• Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• Diabetic and/or hypertensive with clinically significant ocular examination findings
• History of stroke or transient ischemic attack
• Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder)
• Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis)
• Current or history of any clinically significant cardiac abnormalities/dysfunction
• Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
• Myelodysplastic syndromes
• Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
• Pregnant or nursing, or intending to become pregnant during the trial period

• 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

Study Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-4031-376

Identifier Type: OTHER

Identifier Source: secondary_id

P08450

Identifier Type: -

Identifier Source: org_study_id