A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B (CHB). - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00435825

Purpose

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms sc weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS]	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Peginterferon Alfa-2a Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

HBeAg seroconversion [ Time Frame: At end of initial 24 week treatment-free follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Loss of ABeAg, HBsAg seroconversion, loss of HBsAg, ALT, HBV-DNA. [ Time Frame: At end of 24 week treatment-free follow-up, and at week 72. ] [ Designated as safety issue: No ]
HBeAg seroconversion [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	528
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2010

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 90 micrograms sc weekly for 24 weeks.
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 24 weeks
3: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 90 micrograms sc weekly for 48 weeks
4: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 48 weeks

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;
positive HBsAg for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
liver disease consistent with CHB.

Exclusion Criteria:

antiviral therapy for CHB within previous 6 months;
co-infection with HAV, HCV, HDV or HIV;
evidence of decompensated liver disease;
medical condition associated with chronic liver disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435825

Show 52 Study Locations

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:	WV19432
Study First Received:	February 15, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00435825
Health Authority:	United States: Food and Drug Administration

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