Clinical trial NCT01641926: 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)
Official title: A Multicenter Open-label Study to Evaluate the Safety and Efficacy of PEG-Intron™ Versus PEGASYS™ in Subjects With HBeAg Positive Chronic Hepatitis B and HBeAg Negative Chronic Hepatitis B Protocol No. MK-4031-376-00 (Also Known as SCH 054031, P08450)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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

Primary outcomes:
measure: Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment
timeFrame: FU Week 24 (Study Week 72)
measure: Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment
timeFrame: FU Week 24 (Study Week 72)
Secondary outcomes:
measure: Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment
timeFrame: FU Week 24 (Study Week 72)
measure: Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment
timeFrame: FU Week 24 (Study Week 72)
measure: Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment
timeFrame: FU Week 24 (Study Week 72)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Study Director
role: STUDY_DIRECTOR
References: