A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

PHASE3CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

July 11, 2012

Primary Completion Date

July 9, 2015

Study Completion Date

October 18, 2021

Conditions
Hepatitis B, Chronic
Interventions
DRUG

peginterferon alfa-2a [Pegasys]

Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48

DRUG

peginterferon alfa-2a [Pegasys]

Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion

Trial Locations (39)

1200

Cliniques Universitaires St-Luc, Brussels

1612

Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology, Sofia

3053

Royal Children's Hospital; Department of Gastroenterology, Melbourne

5006

Womens and Childrens Hospital; Department of Gastroenterology, North Adelaide

9000

UZ Gent, Ghent

"University Hospital St. Marine; Dept. of Pediatrics", Varna

22100

Western Galilee Hospital - Nahariya, Nahariya

40138

Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive, Bologna

42283

HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke, Wuppertal

63104

St. Louis University - Cardinal Glennon Children's Medical Center, St Louis

77030

Texas Children's Hospital, Houston

94143

Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition, San Francisco

98105

Seattle Children's Hospital, Seattle

100039

Beijing 302 Hospital; No. 2 Infectious Disease Section, Beijing

100069

Beijing You An Hospital; Digestive Dept, Beijing

115446

SFI Sceintific Research institute of nutrition of RAMS, Moscow

119991

SI Sceintific children health center RAMS, Moscow

130021

the First Hospital of Jilin University, Changchun

197022

FSI Scientific research Institute of children's infections, Saint Petersburg

400038

Southwest Hospital , Third Military Medical University, Chongqing

430030

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech, Wuhan

443100

MC Gepatolog, Samara

510060

The Eighth People's Hospital of Guangzhou, Guangzhou

510630

The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou

650032

The First Affilliated Hospital of Kunming Medical College, Kunming

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

830000

Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine, Urumqi (乌鲁木齐)

3109601

Rambam Medical Center, Haifa

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

21287-5554

Johns Hopkins Hospital - Pediatric Gastroenterology, Baltimore

02115

Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology, Boston

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii, Bydgoszcz

31-202

Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci, Krakow

91-347

Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci, Lodz

01119

Kyiv Children's Clinical Infectious Diseases Hospital, Kyiv

04050

SI Institute of the pediatrics, obstetrics and gynecology, Kyiv

B4 6NH

Birmingham Children'S Hopsital; Liver Unit, Birmingham

SE5 9RS

Kings College Hospital NHS Foundation Trust, London

W2 1PG

Imperial College Healthcare Trust, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01519960 - A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B | Biotech Hunter | Biotech Hunter