Trial record 17 of 367 for:    "Hepatitis B, Chronic"

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.
Verified March 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: March 14, 2014
Last verified: March 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
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: March 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hepatitis B, Chronic
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, 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 April 15, 2014