A Study of the Safety and Efficacy of PEG-Intron™ Versus PEGASYS™ in Participants With Chronic Hepatitis B (P08450)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01641926
First received: July 11, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Biological: PEG-Intron™
Biological: PEGASYS™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Proportion of HBeAg(+) participants achieving HBeAg seroconversion at 24 weeks post-treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of HBeAg(-) participants achieving hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels <2000 IU/mL at 24 weeks post-treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of HBeAg(+) participants achieving HBV DNA <2000 IU/mL at 24 weeks post-treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of HBeAg(+) participants achieving alanine aminotransferase (ALT) normalization at 24 weeks post-treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of HBeAg(+) participants achieving the combined response of HBeAg seroconversion and HBV DNA <2000 IU/mL at 24 weeks post-treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: November 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A HBeAg(+) PEG-Intron Biological: PEG-Intron™
PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks
Other Names:
  • SCH 054031
  • Pegylated interferon alfa-2b
Active Comparator: Arm B HBeAg(+) PEGASYS Biological: PEGASYS™
PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks
Other Name: Pegylated interferon alfa-2a
Experimental: Arm A HBeAg(-) PEG-Intron Biological: PEG-Intron™
PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks
Other Names:
  • SCH 054031
  • Pegylated interferon alfa-2b
Active Comparator: Arm B HBeAG(-) PEGASYS Biological: PEGASYS™
PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks
Other Name: Pegylated interferon alfa-2a

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria for All Participants:

  • 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(+)

Key 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641926

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Gary Jankelowitz    61 2 8988 8246      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Hong Kong
Merck Sharp & Dohme (Asia) Ltd. Recruiting
Hong Kong, Hong Kong
Contact: Lai Hung Jen    886 2 2730 0030      
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Cem Ozesen    90 212 3361260      
Malaysia
MSD Recruiting
Petaling Jaya, Malaysia
Contact: Boon Hock Yeoh    60 377181723      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Singapore
Merck Sharp & Dohme (I.A.) Corp Recruiting
Singapore, Singapore
Contact: Cesar Recto    632 784 9500      
Thailand
MSD (Thailand) Ltd. Recruiting
Bangkok, Thailand
Contact: Thanu Komolsai    66 2262 5746      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01641926     History of Changes
Other Study ID Numbers: P08450, MK-4031-376
Study First Received: July 11, 2012
Last Updated: April 22, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2a
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014