Clinical trial NCT00048945: Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-11-14
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hepatitis B
* Not pregnant

Exclusion Criteria:

* Treatment for hepatitis B in past 6 months
* Other hepatitis infections
* Severe liver disease
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Downey
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Lincoln
country: United States
state: Nebraska
city: Chapel Hill
country: United States
state: North Carolina
city: Cedar Creek
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Concord
country: Australia
city: Herston
country: Australia
city: Campinas
country: Brazil
city: Porto Alegre
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hong Kong
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Clichy
country: France
city: Lyon
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Duesseldorf
country: Germany
city: Hannover
country: Germany
city: Koeln
country: Germany
city: Muenchen
country: Germany
city: Haifa
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Otahuhu
country: New Zealand
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Warszawa
country: Poland
city: Santurce
country: Puerto Rico
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Basel
country: Switzerland
city: Kaohsiung
country: Taiwan
city: Kwei Shan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Songkla
country: Thailand
city: Nottingham
country: United Kingdom
Study officials:
References: