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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01641926
First received: July 11, 2012
Last updated: August 13, 2014
Last verified: August 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: February 2016
Estimated Primary Completion Date: February 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.

No Contacts or Locations Provided
  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: August 13, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on October 21, 2014