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

Last updated: August 21, 2020
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02263079
NV25361
2006-000977-31
  • Ages 3-17
  • All Genders

Study Summary

This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Positive for HBsAg and HBeAg for more than 6 months prior to baseline

  • Detectable HBV-DNA (>20,000 IU/mL) as measured by polymerization chain reaction (PCR)or hybridization on at least 2 occasions at least one month apart with the latestdetermination obtained less than or equal to (</=) 42 days prior to baseline

  • Compensated liver disease (Child-Pugh Class A clinical classification)

  • Either Liver biopsy performed within 2 years prior to baseline showing no or minimalfibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal toupper limit of normal [ULN]) during the 6 months leading up to baseline (including twoseparate occasions at least 1 month apart over the 6 months prior to baseline).Screening ALT levels must be normal (</= ULN) OR Stable normal ALT levels (</= ULN),during the 1 year leading up to baseline (including three separate occasions at least 1 month apart over the 1 year prior to baseline) and no signs of hepatocellularcarcinoma (HCC), advanced fibrosis/cirrhosis, or splenomegaly on liver abdominalultrasound at screening. Screening ALT levels must be normal (</= ULN)

Exclusion

Exclusion Criteria:

  • Participants who have received investigational drugs or licensed treatments with antiHBV activity (Exception: Participants who have had a limited [</= 7-day] course ofacyclovir for herpetic lesions more than 1 month before the study baseline visit arenot excluded)

  • Participants who have participated in any other clinical trial or who have receivedany investigational drug within 6 months prior to baseline

  • Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudineor entecavir

  • Positive test results at screening for hepatitis A virus Immunoglobulin M (IgM)antibody (Ab), anti-hepatitis C virus (HCV) Ab, anti- hepatitis D (HDV) Ab oranti-human immunodeficiency virus (HIV) Ab

  • Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification orclinical evidence such as ascites or varices)

  • Advanced fibrosis or cirrhosis

  • Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominalultrasound within 6 months prior to baseline)

  • History or other evidence of a medical condition associated with chronic liver diseaseother than CHB including metabolic liver diseases such as hemochromatosis, Wilson'sdisease or alpha-1 anti-trypsin deficiency

  • Active substance abuse within 6 months prior to screening

  • Sexually active females of childbearing potential and sexually active males who arenot willing to utilize reliable contraception during treatment and for 90 daysfollowing the end of treatment

  • Females who are pregnant or who are breastfeeding (females of childbearing potentialwho have a positive urine or serum pregnancy test result within 24 hours of baselineare excluded)

Study Design

Total Participants: 62
Study Start date:
June 16, 2014
Estimated Completion Date:
January 29, 2020

Connect with a study center

  • Womens and Childrens Hospital; Department of Gastroenterology

    North Adelaide, South Australia 5006
    Australia

    Site Not Available

  • Royal Children's Hospital; Department of Gastroenterology

    Melbourne, Victoria 3053
    Australia

    Site Not Available

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Hospital das Clinicas - FMUSP; Instituto da Crianca

    Sao Paulo, SP 05403-000
    Brazil

    Site Not Available

  • Hospital Infantil Dr. Robert Reid Cabral

    Santo Domingo, 10101
    Dominican Republic

    Site Not Available

  • Ain Shams University Faculty of Medicine, El-Demerdash Hospital; Pediatrics

    Cairo, 11566
    Egypt

    Site Not Available

  • Menoufiya University-National Liver Institute-Puplic Health

    Menoufiya, 32511
    Egypt

    Site Not Available

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

    Essen, 45122
    Germany

    Site Not Available

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

    Mainz, 55131
    Germany

    Site Not Available

  • Dr. von Haunerschen Kinderspital, Kinderchirurgische Klinik und Poliklinik

    München, 80337
    Germany

    Site Not Available

  • Klinikum Starnberg, Klinik für Kinder- und Jugendmedizin

    Starnberg, 82319
    Germany

    Site Not Available

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

    Wuppertal, 42283
    Germany

    Site Not Available

  • Clinica Privada Dr. Carlos Mejia Villatoro

    Ciudad de Guatemala, 01001
    Guatemala

    Site Not Available

  • Osmania General Hospital; Department fo Gastroenterology

    Hyderabad, Andhra Pradesh 500012
    India

    Site Not Available

  • St.Jhon Medical College and Hospital; Dept. of Gastroenterology

    Bangalore, Karnataka 560034
    India

    Site Not Available

  • KEM Hospital

    Pune, Maharashtra 411011
    India

    Site Not Available

  • Sparsh Hospital

    Bhubaneshwar, Odisha 751007
    India

    Site Not Available

  • Institute of Child Health; Pediatrics

    Kolkata, West Bengal 700017
    India

    Site Not Available

  • empty

    Hyderabad 12,
    India

    Site Not Available

  • King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College

    Maharashtra, 400012
    India

    Site Not Available

  • empty

    New Delhi, 110060
    India

    Site Not Available

  • Soroka Medical Center

    Beer Sheva, 8410101
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Rambam Medical Center

    Halfa, 31096
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 91031
    Israel

    Site Not Available

  • Assaf Harofeh; Gastroenterology

    Zerifin, 6093000
    Israel

    Site Not Available

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

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • ASST PAPA GIOVANNI XXIII; Epatologia e gastroenterologia pediatrica e dei trapianti

    Bergamo, Lombardia 24127
    Italy

    Site Not Available

  • A.O. Universitaria di Padova; Dip. Salute della Donna e Bambino-S.S.Malattie Infettive Pediatriche

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - Oncology

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • University Malaya Medical Center; Department of Paediatrics

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Grigore Alexandrescu Emergency Clinical Hospital for Children

    Bucharest, 011743
    Romania

    Site Not Available

  • Emergency Clinical Hospital for Children Cluj-Napoca

    Cluj-Napoca, 400177
    Romania

    Site Not Available

  • St. Maria Emergency Clinical Hospital for Children

    Iasi, 700309
    Romania

    Site Not Available

  • Louis Turcanu Emergency Clinical Hospital for Children; First Pediatric Clinic

    Timisoara, 300011
    Romania

    Site Not Available

  • Arkhangelsk regional clinical hospital;Infections diseases

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997
    Russian Federation

    Site Not Available

  • FSI Scientific research Institute of children's infections

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • MC Gepatolog

    Samara, 443100
    Russian Federation

    Site Not Available

  • empty

    St Petersburg,
    Russian Federation

    Site Not Available

  • National University Hospital, University Children's Medical Institute; Department of Paediatrics

    Singapore, 119228
    Singapore

    Site Not Available

  • National Taiwan University Hospital; Department of Paediatrics

    Taipei, 100
    Taiwan

    Site Not Available

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

    Taoyuan County, 333
    Taiwan

    Site Not Available

  • RAMATHIBODI HOSPITAL; Faculty of Medicine ;DEPT OF PEDIATRICS

    Bangkok,
    Thailand

    Site Not Available

  • Cukurova University Medical School Department of Pediatrics; Pediatric Infectious Diseases

    Adana, 01330
    Turkey

    Site Not Available

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

    Ankara, 06100
    Turkey

    Site Not Available

  • Gazi Universitesi Tip Fakultesi Pediyatri Anabilim Dalı; Pediyatrik Gastroenteroloji

    Ankara, 06500
    Turkey

    Site Not Available

  • Hacettepe Uni , School of Medicine; Gastroenterology

    Ankara, 06100
    Turkey

    Site Not Available

  • Gaziantep University School of Medicine, Pediatrics Department; Pediatric Gastroenterology

    Gaziantep, 27310
    Turkey

    Site Not Available

  • Dnipropetrovsk Medical Academy; Infections diseases

    Dnipropetrovsk, 49006
    Ukraine

    Site Not Available

  • SI Institute of the pediatrics, obstetrics and gynecology

    Kyiv, 04050
    Ukraine

    Site Not Available

  • Vinnytsia National Medical University; Infections diseases

    Vinnytsia, 21021
    Ukraine

    Site Not Available

  • Birmingham Children'S Hopsital; Liver Unit

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7AU
    United Kingdom

    Site Not Available

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • North Manchester General Hospital

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • University of California San Francisco; Department of Pediatrics

    San Francisco, California 94158
    United States

    Site Not Available

  • Children's Mercy Hosp Clinics

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032-3725
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Texas Children's Hospital - Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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