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A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00436163
First received: February 15, 2007
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: Peginterferon alfa-2a
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.

  • Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.


Secondary Outcome Measures:
  • Number of Participants With HBV-DNA < 400 Copies/mL [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.

  • Percentage of Anti-HBs Positive Participants [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.

  • Mean Alanine Aminotransferase (ALT) Concentrations [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
  • Percentage of HBeAg Negative Participants [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.

  • Percentage of Anti-HBe Positive Participants [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.


Enrollment: 39
Study Start Date: March 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginterferon Alfa-2a
Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Drug: Peginterferon alfa-2a
180 mcg subcutaneously once per week for 48 weeks.
Other Name: Pegasys®

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants, 18-70 years of age;
  • HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
  • anti-HBs negative;
  • Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.

Exclusion Criteria:

  • Previous antiviral or interferon-based therapy for chronic hepatitis B;
  • Evidence of decompensated liver disease;
  • Chronic liver disease other than viral hepatitis;
  • Co-infection with active hepatitis A, C or D virus;
  • Co-infection with human immunodeficiency virus.
  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: NCT00436163

Locations
Estonia
Tallinn, Estonia, 10138
Tallinn, Estonia, 10617
Tartu, Estonia, 51014
Latvia
Riga, Latvia, 1006
Lithuania
Kaunas, Lithuania, 47144
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 92288
Vilnius, Lithuania, 08117
Vilnius, Lithuania, 08661
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00436163     History of Changes
Other Study ID Numbers: ML20601 
Study First Received: February 15, 2007
Results First Received: August 31, 2016
Last Updated: August 31, 2016
Health Authority: Estonia: State Agency of Medicines of the Republic of Estonia
Latvia: State Agency of Medicines of the Republic of Latvia
Lithuania: State Medicines Control Agency of Lithuania

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016