SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00442572
First received: February 15, 2007
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 'A Randomized, Open-label Study to Investigate the Effect on Sustained Virologic Response, and the Safety, of Intermittent Long Term Treatment With PEGASYS in Patients With HBeAg Negative Chronic Hepatitis B Who Have Responded to Previous Treatment With Interferon Alfa.' (SOFIA-LTT Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Duration of treatment response (Serum HBV DNA <100,000 copies/mL) [ Time Frame: After each treatment, and after 24 weeks of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of treatment response [ Time Frame: Every 12 weeks, and after follow-up. ] [ Designated as safety issue: No ]
  • Loss of HbsAg and seroconversion, and HBV DNA BLQ. [ Time Frame: At end of follow up ] [ Designated as safety issue: No ]
  • Changes in liver fibrosis, AEs, lab parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: July 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
4 cycles of 135 micrograms sc weekly for 12 weeks followed by no treatment for 12 weeks.
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • liver disease consistent with CHB;
  • evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
  • patients who have responded to previous 48 weeks treatment with interferon alfa.

Exclusion Criteria:

  • coinfection with HCV, HDV or HIV;
  • decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
  • any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442572

Locations
Bulgaria
Sofia, Bulgaria, 1612
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: NCT00442572     History of Changes
Other Study ID Numbers: ML20020
Study First Received: February 15, 2007
Last Updated: April 7, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency

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 17, 2014