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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00436163
First received: February 15, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436163

Locations
Estonia
Tallinn, Estonia, 10617
Tallinn, Estonia, 10138
Tartu, Estonia, 51014
Latvia
Riga, Latvia, 1006
Lithuania
Kaunas, Lithuania, 50009
Kaunas, Lithuania, 47144
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00436163     History of Changes
Other Study ID Numbers: ML20601
Study First Received: February 15, 2007
Last Updated: May 23, 2013
Health Authority: Estonia:State Agency of Medicines of Estonia

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013