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)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Biological: PEGASYS™; Biological: PEG-Intron™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01641926

P08450

MK-4031-376 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Inclusion Criteria for HBeAg(+) participants:

• HBeAg(+)
• Anti-HBe(-)

Inclusion Criteria for HBeAg(-) participants:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 4 patient groups

HBeAg(+) PEG-Intron

Experimental group

Description:

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

Treatment:

Biological: PEG-Intron™

HBeAg(+) PEGASYS

Active Comparator group

Description:

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

Treatment:

Biological: PEGASYS™

HBeAg(-) PEG-Intron

Experimental group

Description:

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

Treatment:

Biological: PEG-Intron™

HBeAG(-) PEGASYS

Active Comparator group

Description:

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

Treatment:

Biological: PEGASYS™