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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00487747
First received: June 18, 2007
Last updated: February 15, 2010
Last verified: February 2010
  Purpose

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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 of the Effect of PEGASYS on Treatment Response in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HBV DNA <100,000 copies/mL (HBeAg positive patients) [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • HBV DNA <20,000 copies/mL (HBeAg negative patients) [ Time Frame: Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBV DNA <400 copies/mL, HbsAg seroconversion, ALT normalization, sustained HBe seroconversion in HBeAg positive patients. [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 19
Study Completion Date: October 2009
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;
  • chronic hepatitis B;
  • HBV DNA >100,000 copies/mL.

Exclusion Criteria:

  • previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
  • evidence of decompensated liver disease;
  • history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
  • coinfection with hepatitis A, C or D, or HIV.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487747

Locations
Russian Federation
Chelyabinsk, Russian Federation, 454052
Ekaterinburg, Russian Federation, 620020
Ekaterinburg, Russian Federation, 620102
Irkutsk, Russian Federation, 664047
Kazan, Russian Federation, 420097
Krasnoyarsk, Russian Federation, 660049
Moscow, Russian Federation, 123367
Moscow, Russian Federation
Moscow, Russian Federation, 115516
Moscow, Russian Federation, 111020
Moscow, Russian Federation, 121293
Nizhny Novgorod, Russian Federation, 603022
Novokuznetsk, Russian Federation, 654063
Novosibirsk, Russian Federation, 630016
Rostov-na-donu, Russian Federation, 344010
Samara, Russian Federation, 443021
St Petersburg, Russian Federation, 190103
Stavropol, Russian Federation, 355017
Tomsk, Russian Federation, 634050
Tumen, Russian Federation, 625002
Ufa, Russian Federation, 450000
Volgograd, Russian Federation, 400138
Yakutsk, Russian Federation, 677000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00487747     History of Changes
Other Study ID Numbers: ML20003
Study First Received: June 18, 2007
Last Updated: February 15, 2010
Health Authority: Russia: Federal Agency of drug quality control

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 April 20, 2014