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)
- Conditions
- Hepatitis B, Chronic
- Interventions
- Biological: PEG-Intron™Biological: PEGASYS™
- Registration Number
- NCT01641926
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 402
- 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(+)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HBeAg(+) PEG-Intron PEG-Intron™ HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks. HBeAg(-) PEG-Intron PEG-Intron™ HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks. HBeAg(+) PEGASYS PEGASYS™ HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks. HBeAG(-) PEGASYS PEGASYS™ HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
- Primary Outcome Measures
Name Time Method Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment FU Week 24 (Study Week 72) Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.
Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment FU Week 24 (Study Week 72) The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported.
- Secondary Outcome Measures
Name Time Method Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment FU Week 24 (Study Week 72) HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels \<2000 IU/mL at 24 weeks post-treatment was reported.
Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment FU Week 24 (Study Week 72) The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported.
Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment FU Week 24 (Study Week 72) ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported.