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)

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01641926
• Other study ID #: P08450
• Secondary ID: MK-4031-376
• Status: Terminated
• Phase: Phase 3
• Start date: November 26, 2012
• Est. completion date: January 21, 2016

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• PEG-Intron™
PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks
• PEGASYS™
PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

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)