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). - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00442572

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 (40KD) [PEGASYS]	Phase II

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Peginterferon Alfa-2a Hepatitis B Vaccines Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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)

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 ]

Estimated Enrollment:	100
Study Start Date:	July 2006
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 4 cycles of 135 micrograms sc weekly for 12 weeks followed by no treatment for 12 weeks.
2: No Intervention

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

Contacts

Contact: Please reference Study ID Number: ML20020	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Bulgaria
	Recruiting
SOFIA, Bulgaria

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20020
Study First Received:	February 15, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00442572
Health Authority:	Bulgaria: Bulgarian Drug Agency

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases

Digestive System Diseases
Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2a
DNA Virus Infections
Interferon Alfa-2a

Additional relevant MeSH terms:

Anti-Infective Agents
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors

Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009