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Summary

for people ages 3–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Phase IIIb, Randomized, Open-Label Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Patients in Children With HBeAg Positive Chronic Hepatitis B in the Immune-Tolerant Phase

Keywords

Hepatitis B, Chronic Interferons Interferon-alpha Lamivudine Entecavir Peginterferon alfa-2a

Eligibility

You can join if…

Open to people ages 3–17

  • 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 latest determination 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 minimal fibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal to upper limit of normal [ULN]) during the 6 months leading up to baseline (including two separate 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 hepatocellular carcinoma (HCC), advanced fibrosis/cirrhosis, or splenomegaly on liver abdominal ultrasound at screening. Screening ALT levels must be normal (</= ULN)

You CAN'T join if...

  • Participants who have received investigational drugs or licensed treatments with anti

HBV activity (Exception: Participants who have had a limited [</= 7-day] course of acyclovir for herpetic lesions more than 1 month before the study baseline visit are not excluded)

  • Participants who have participated in any other clinical trial or who have received any investigational drug within 6 months prior to baseline
  • Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudine or 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 or anti-human immunodeficiency virus (HIV) Ab
  • Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices)
  • Advanced fibrosis or cirrhosis
  • Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominal ultrasound within 6 months prior to baseline)
  • History or other evidence of a medical condition associated with chronic liver disease other than CHB including metabolic liver diseases such as hemochromatosis, Wilson's disease 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 are not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment
  • Females who are pregnant or who are breastfeeding (females of childbearing potential who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded)

Locations

  • Children's Mercy Hosp Clinics in progress, not accepting new patients
    Kansas City, Missouri, 64108, United States
  • Texas Children's Hospital - Baylor College of Medicine not yet accepting patients
    Houston, Texas, 77030, United States
  • Clinica Privada Dr. Carlos Mejia Villatoro terminated
    Ciudad de Guatemala, 01001, Guatemala
  • The Children's Hospital of Philadelphia accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Columbia University accepting new patients
    New York, New York, 10032, United States
  • Hospital Infantil Dr. Robert Reid Cabral withdrawn
    Santo Domingo, 10101, Dominican Republic
  • Arkhangelsk regional clinical hospital;Infections diseases withdrawn
    Arkhangelsk, 163045, Russian Federation
  • SFI Sceintific Research institute of nutrition of RAMS accepting new patients
    Moscow, 115446, Russian Federation
  • Russian Scientific Center of Roentgenoradiology withdrawn
    Moscow, 117997, Russian Federation
  • SI Sceintific children health center RAMS terminated
    Moscow, 119991, Russian Federation
  • FSI Scientific research Institute of children's infections in progress, not accepting new patients
    Saint Petersburg, 197022, Russian Federation
  • MC Gepatolog accepting new patients
    Samara, 443100, Russian Federation
  • Birmingham Children'S Hopsital; Liver Unit in progress, not accepting new patients
    Birmingham, B4 6NH, United Kingdom
  • Leeds Teaching Hospitals NHS Trust accepting new patients
    Leeds, LS9 7AU, United Kingdom
  • The Royal London Hospital; The Childrens Department terminated
    London, E11BB, United Kingdom
  • Kings College Hospital NHS Foundation Trust accepting new patients
    London, SE5 9RS, United Kingdom
  • North Manchester General Hospital accepting new patients
    Manchester, M8 5RB, United Kingdom
  • Hospital das Clinicas - FMUSP; Instituto da Crianca withdrawn
    Sao Paulo, SP, 05403-000, Brazil
  • Cliniques Universitaires St-Luc accepting new patients
    Bruxelles, 1200, Belgium
  • UZ Gent accepting new patients
    Gent, 9000, Belgium
  • Severance Hospital, Yonsei University Health System accepting new patients
    Seoul, 03722, Korea, Republic of
  • Asan Medical Center accepting new patients
    Seoul, 05505, Korea, Republic of
  • Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II accepting new patients
    Essen, 45122, Germany
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin accepting new patients
    Mainz, 55131, Germany
  • Dr. von Haunerschen Kinderspital, Kinderchirurgische Klinik und Poliklinik accepting new patients
    München, 80337, Germany
  • Klinikum Starnberg, Klinik für Kinder- und Jugendmedizin withdrawn
    Starnberg, 82319, Germany
  • HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke accepting new patients
    Wuppertal, 42283, Germany
  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive in progress, not accepting new patients
    Bologna, Emilia-Romagna, 40138, Italy
  • ASST PAPA GIOVANNI XXIII; Epatologia e gastroenterologia pediatrica e dei trapianti accepting new patients
    Bergamo, Lombardia, 24127, Italy
  • A.O. Universitaria di Padova; Dip. Salute della Donna e Bambino-S.S.Malattie Infettive Pediatriche terminated
    Padova, Veneto, 35128, Italy
  • Dnipropetrovsk Medical Academy; Infections diseases terminated
    Dnipropetrovsk, 49006, Ukraine
  • Kyiv Children's Clinical Infectious Diseases Hospital withdrawn
    Kyiv, 01119, Ukraine
  • SI Institute of the pediatrics, obstetrics and gynecology accepting new patients
    Kyiv, 04050, Ukraine
  • Vinnytsia National Medical University; Infections diseases accepting new patients
    Vinnytsia, 21021, Ukraine
  • Grigore Alexandrescu Emergency Clinical Hospital for Children accepting new patients
    Bucharest, 011743, Romania
  • Matei Bals Infectios Disease Institute terminated
    Bucharest, 021105, Romania
  • Emergency Clinical Hospital for Children Cluj-Napoca terminated
    Cluj-Napoca, 400177, Romania
  • St. Maria Emergency Clinical Hospital for Children terminated
    Iasi, 700309, Romania
  • Louis Turcanu Emergency Clinical Hospital for Children; First Pediatric Clinic terminated
    Timisoara, 300011, Romania
  • National Taiwan University Hospital; Department of Paediatrics accepting new patients
    Taipei, 100, Taiwan
  • Chang-Gung Memorial Hospital-Linkou; Division of Pediatric Gastroenterology, Dept. Pediatrics in progress, not accepting new patients
    Taoyuan County, 333, Taiwan
  • Cukurova University Medical School Department of Pediatrics; Pediatric Infectious Diseases in progress, not accepting new patients
    Adana, 01330, Turkey
  • Ankara University School of Medicine, Pediatrics Department; Pediatric Gastroenterology in progress, not accepting new patients
    Ankara, 06100, Turkey
  • Hacettepe Uni , School of Medicine; Gastroenterology accepting new patients
    Ankara, 06100, Turkey
  • Gazi Universitesi Tip Fakultesi Pediyatri Anabilim Dalı; Pediyatrik Gastroenteroloji accepting new patients
    Ankara, 06500, Turkey
  • Gaziantep University School of Medicine, Pediatrics Department; Pediatric Gastroenterology withdrawn
    Gaziantep, 27310, Turkey
  • Soroka Medical Center accepting new patients
    Beer Sheva, 8410101, Israel
  • Rambam Medical Center accepting new patients
    Haifa, 31096, Israel
  • Shaare Zedek Medical Center accepting new patients
    Jerusalem, 91031, Israel
  • Assaf Harofeh; Gastroenterology accepting new patients
    Zerifin, 6093000, Israel
  • Ain Shams University Faculty of Medicine, El-Demerdash Hospital; Pediatrics withdrawn
    Cairo, 11566, Egypt
  • National Hepatology and Tropical Medicine Research Institute; Pediatrics withdrawn
    Cairo, Egypt
  • Menoufiya University-National Liver Institute-Puplic Health withdrawn
    Menoufiya, 32511, Egypt
  • Chulalongkorn university Faculty of Medicine;Department of Pediatrics accepting new patients
    Bangkok, 10310, Thailand
  • RAMATHIBODI HOSPITAL; Faculty of Medicine ;DEPT OF PEDIATRICS accepting new patients
    Bangkok, Thailand
  • Womens and Childrens Hospital; Department of Gastroenterology accepting new patients
    North Adelaide, South Australia, 5006, Australia
  • Royal Children's Hospital; Department of Gastroenterology accepting new patients
    Melbourne, Victoria, 3053, Australia
  • University Malaya Medical Center; Department of Paediatrics accepting new patients
    Kuala Lumpur, 59100, Malaysia
  • Osmania General Hospital; Department fo Gastroenterology withdrawn
    Hyderabad, Andhra Pradesh, 500012, India
  • St.Jhon Medical College and Hospital; Dept. of Gastroenterology withdrawn
    Bangalore, Karnataka, 560034, India
  • KEM Hospital accepting new patients
    Pune, Maharashtra, 411011, India
  • Sparsh Hospital not yet accepting patients
    Bhubaneshwar, Odisha, 751007, India
  • Institute of Child Health; Pediatrics not yet accepting patients
    Kolkata, West Bengal, 700017, India
  • King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College not yet accepting patients
    Maharashtra, 400012, India
  • National University Hospital, University Children's Medical Institute; Department of Paediatrics accepting new patients
    Singapore, 119228, Singapore

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02263079
Phase
Phase 3
Study Type
Interventional
Last Updated
September 1, 2017
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