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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B (CHB).

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: February 15, 2007
Last updated: April 2, 2016
Last verified: April 2016
This single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s.c. 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 <100 individuals.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study Evaluating Safety and the Effect of PEGASYS® on HBV DNA Levels 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 patients with HBV DNA <100,000 copies/mL [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBV DNA <400 copies/mL, HBsAg seroconversion, ALT normalization, sustained HBe seroconversion. [ Time Frame: Weeks 48 and 72 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 38
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: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks


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

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • HBeAg positive, HBsAg positive for >=6 months;
  • anti-HBs negative;
  • HBV DNA >500,000 copies/mL.

Exclusion Criteria:

  • previous antiviral or interferon-based therapy for CHB;
  • 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 (HIV).
  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 identifier: NCT00436163

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00436163     History of Changes
Other Study ID Numbers: ML20601 
Study First Received: February 15, 2007
Last Updated: April 2, 2016
Health Authority: Estonia:State Agency of Medicines of Estonia

Additional relevant MeSH terms:
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
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 28, 2016