Hepatitis B, Chronic Clinical Trial
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)
Verified date | July 2018 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 402 |
Est. completion date | January 21, 2016 |
Est. primary completion date | January 21, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment | 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. | FU Week 24 (Study Week 72) | |
Primary | Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment | 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. | FU Week 24 (Study Week 72) | |
Secondary | Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | 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. | FU Week 24 (Study Week 72) | |
Secondary | Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | 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. | FU Week 24 (Study Week 72) | |
Secondary | Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | 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. | FU Week 24 (Study Week 72) |
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