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: September 22, 2014
Last verified: September 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 demon strated virological and biochemical response after treatment with interferon alf

a. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free foll ow-up, eligible patients will be randomized into the PEGASYS or the observationa l group. Those in the PEGASYS group will receive 4 therapeutic cycles of long te rm intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, f ollowed by a treatment-free period of 12 weeks) and those in the observational a rm will receive no specific antiviral treatment. The anticipated time on study t reatment 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
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: 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: September 22, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency

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 30, 2014