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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: November 13, 2014
Last verified: November 2014

July 11, 2012
November 13, 2014
November 2012
February 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01641926 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of PEG-Intron™ Versus PEGASYS™ in Participants With Chronic Hepatitis B (P08450)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Biological: PEG-Intron™
    PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks
    Other Names:
    • SCH 054031
    • Pegylated interferon alfa-2b
  • 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
    Intervention: Biological: PEG-Intron™
  • Active Comparator: Arm B HBeAg(+) PEGASYS
    Intervention: Biological: PEGASYS™
  • Experimental: Arm A HBeAg(-) PEG-Intron
    Intervention: Biological: PEG-Intron™
  • Active Comparator: Arm B HBeAG(-) PEGASYS
    Intervention: Biological: PEGASYS™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1400
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01641926
P08450, MK-4031-376
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP