A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase

PHASE3CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

June 16, 2014

Primary Completion Date

January 29, 2020

Study Completion Date

January 29, 2020

Conditions
Pediatric Immuno-Tolerant Chronic Hepatitis B
Interventions
DRUG

Entecavir

Participants will receive entecavir, either as a film-coated tablet or oral solution, once daily at a dose of 0.015 milligrams per kilogram (mg/kg) (maximum daily dose of 0.5 mg).

DRUG

Lamivudine

Participants will receive lamivudine, either as a film-coated tablet or oral solution, once daily at a dose of 3 mg/kg (maximum daily dose of 100 mg).

DRUG

Pegylated Interferon Alfa-2A

Participants will receive pegylated interferon-alfa-2A at a body surface area (BSA) based dose of 180 micrograms per 1.73 square meter (mcg/1.73m\^2) BSA.

Trial Locations (25)

333

Chang-Gung Memorial Hospital-Linkou; Division of Pediatric Gastroenterology, Dept Pediatrics, Taoyuan

1200

Cliniques Universitaires St-Luc, Brussels

5006

Womens and Childrens Hospital; Department of Gastroenterology, North Adelaide

9000

UZ Gent, Ghent

19104

The Children's Hospital of Philadelphia, Philadelphia

40138

Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive, Bologna

42283

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

45122

Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II, Essen

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Mainz

59100

University Malaya Medical Center; Department of Paediatrics, Kuala Lumpur

64108

Children's Mercy Hosp Clinics, Kansas City

80337

Dr. von Haunerschen Kinderspital, Kinderchirurgische Klinik und Poliklinik, München

197022

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

443100

MC Gepatolog, Samara

10032-3725

Columbia University, New York

011743

Grigore Alexandrescu Emergency Clinical Hospital for Children, Bucharest

01330

Cukurova University Medical School Department of Pediatrics; Pediatric Infectious Diseases, Adana

06100

Ankara University School of Medicine, Pediatrics Department; Pediatric Gastroenterology, Ankara

Hacettepe Uni , School of Medicine; Gastroenterology, Ankara

06500

Gazi Universitesi Tip Fakultesi Pediyatri Anabilim Dalı; Pediyatrik Gastroenteroloji, Ankara

04050

SI Institute of the pediatrics, obstetrics and gynecology, Kyiv

B4 6NH

Birmingham Children'S Hopsital; Liver Unit, Birmingham

LS9 7AU

Leeds Teaching Hospitals NHS Trust, Leeds

SE5 9RS

Kings College Hospital NHS Foundation Trust, London

M8 5RB

North Manchester General Hospital, Manchester

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02263079 - A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase | Biotech Hunter | Biotech Hunter