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

This study has been terminated.
(Low recruitment rate due to treatment regimen change)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00460850
First received: April 16, 2007
Last updated: June 27, 2008
Last verified: June 2008
  Purpose

This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 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 (40KD) [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 to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Normalization of ALT, and HBV-DNA <10,000 copies/mL [ Time Frame: Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Normalization of ALT, and HBV-DNA <10,000 copies/mL [ Time Frame: Weeks 48 and 72 ] [ Designated as safety issue: No ]
  • HBsAg loss and anti-HBs seroconversion [ Time Frame: Weeks 48, 72 and 96 ] [ Designated as safety issue: No ]
  • AEs and lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Study Completion Date: June 2008
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • HBeAg negative chronic hepatitis B;
  • treated with lamivudine for >=6 months;
  • demonstrated lamivudine resistance;
  • compensated liver disease.

Exclusion Criteria:

  • severe hepatic dysfunction;
  • previous treatment with antivirals other than lamivudine;
  • immunosuppressant treatment in past 6 months;
  • co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
  • medical condition associated with chronic liver disease.
  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: NCT00460850

Locations
Turkey
Ankara, Turkey, 06620
Antalya, Turkey, 07058
Istanbul, Turkey, 34390
Izmir, Turkey, 35360
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00460850     History of Changes
Other Study ID Numbers: ML20135
Study First Received: April 16, 2007
Last Updated: June 27, 2008
Health Authority: Turkey: Ministry of Health General Management of Drugs and Pharmaceutics Ethics Committee.

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
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014