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

Condition(s) targeted: Hepatitis B, Chronic

Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

Overall contact:
Please reference Study ID Number: PDO_WV19432, Phone: 973-235-5000

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.

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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HBeAg seroconversion

Secondary outcome:

Loss of ABeAg, HBsAg seroconversion, loss of HBsAg, ALT, HBV-DNA.

HBeAg seroconversion

AEs, laboratory parameters.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Please reference Study ID Number: PDO_WV19432, Phone: 973-235-5000

BRISBANE 4120, Australia; Recruiting

FITZROY 3065, Australia; Recruiting

RIBEIRÃO PRETO 14049-900, Brazil; Recruiting

CAMPINAS 13081-970, Brazil; Recruiting

SALVADOR 40150-130, Brazil; Recruiting

SANTO ANDRE 09060-650, Brazil; Recruiting

SAO PAULO 05403-000, Brazil; Recruiting

HONG KONG 852, China; Recruiting

HONG KONG, China; Recruiting

SHANGHAI 201508, China; Recruiting

BEIJING 100050, China; Recruiting

BEIJING 100054, China; Recruiting

GUANGZHOU 510630, China; Recruiting

SHANGHAI 200025, China; Recruiting

HUNAN 410008, China; Recruiting

CLICHY 92118, France; Recruiting

TOULOUSE 31078, France; Recruiting

VILLEJUIF 94804, France; Recruiting

MONTPELLIER 34295, France; Recruiting

STRASBOURG 67091, France; Recruiting

NICE 06202, France; Recruiting

FREIBURG 79106, Germany; Recruiting

BERLIN 13353, Germany; Recruiting

FRANKFURT AM MAIN 60590, Germany; Recruiting

KÖLN 50937, Germany; Recruiting

SEOUL 110-744, Korea, Republic of; Recruiting

SEOUL, Korea, Republic of; Recruiting

SEOUL 120-752, Korea, Republic of; Recruiting

AUCKLAND, New Zealand; Recruiting

HAMILTON, New Zealand; Recruiting

ST PETERSBURG 190103, Russian Federation; Recruiting

SMOLENSK 214006, Russian Federation; Recruiting

SAMARA 443021, Russian Federation; Recruiting

STAVROPOL 355017, Russian Federation; Recruiting

SINGAPORE 169608, Singapore; Recruiting

TAIPEI 100, Taiwan; Recruiting

KUEISHAN, Taiwan; Recruiting

KAOHSIUNG 807, Taiwan; Recruiting

SONGKHLA 90112, Thailand; Recruiting

BANGKOK 10400, Thailand; Recruiting

CHIANG MAI 50202, Thailand; Recruiting

BANGKOK 10700, Thailand; Active, not recruiting

KHON KAEN 40002, Thailand; Recruiting

PALO ALTO, California 94304-1509, United States; Recruiting

SAN DIEGO, California 92115, United States; Recruiting

SAN JOSE, California 95116, United States; Recruiting

LOS ANGELES, California 90095, United States; Recruiting

ATLANTA, Georgia 30322, United States; Recruiting

FLUSHING, New York 11355, United States; Recruiting

PORTLAND, Oregon 97227, United States; Recruiting

RICHMOND, Virginia 23249, United States; Recruiting

Starting date: March 2007
Ending date: April 2010
Last updated: October 15, 2008