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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: February 15, 2007
Last updated: October 1, 2015
Last verified: October 2015
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


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

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
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: NCT00442572

Sofia, Bulgaria, 1612
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT00442572     History of Changes
Other Study ID Numbers: ML20020 
Study First Received: February 15, 2007
Last Updated: October 1, 2015
Health Authority: Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 08, 2016