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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 parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

Official Title

A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Keywords

Hepatitis B, Chronic Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Peginterferon alfa-2a Interferon-alpha

Eligibility

You can join if…

Open to people ages 3–17

  • Male or female patients, 3 years to <18 years of age at baseline
  • Positive HBsAg for more than 6 months
  • Positive HBeAg and detectable HBV DNA at screening
  • Negative anti-HBs and anti-HBe at screening
  • A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis
  • Compensated liver disease (Child-Pugh Class A)
  • Elevated serum alanine transferase (ALT)
  • Normal thyroid gland function at screening

You CAN'T join if...

  • Subjects with cirrhosis
  • Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded
  • Known hypersensitivity to peginterferon
  • Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection
  • History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B
  • History or evidence of bleeding from esophageal varices
  • Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)
  • History of immunologically mediated disease
  • Pregnant or lactating females

Locations

  • Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition
    San Francisco, California, 94143, United States
  • Seattle Children's Hospital
    Seattle, Washington, 98105, United States
  • Texas Children's Hospital
    Houston, Texas, 77030, United States
  • St. Louis University - Cardinal Glennon Children's Medical Center
    Saint Louis, Missouri, 63104, United States
  • Johns Hopkins Hospital - Pediatric Gastroenterology
    Baltimore, Maryland, 21287-5554, United States
  • Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology
    Boston, Massachusetts, 02115, United States
  • Arkhangelsk regional clinical hospital;Infections diseases
    Arkhangelsk, 163045, Russian Federation
  • SFI Sceintific Research institute of nutrition of RAMS
    Moscow, 115446, Russian Federation
  • SI Sceintific children health center RAMS
    Moscow, 119991, Russian Federation
  • FSI Scientific research Institute of children's infections
    Saint Petersburg, 197022, Russian Federation
  • MC Gepatolog
    Samara, 443100, Russian Federation
  • Birmingham Children'S Hopsital; Liver Unit
    Birmingham, B4 6NH, United Kingdom
  • Kings College Hospital NHS Foundation Trust
    London, SE5 9RS, United Kingdom
  • Imperial College Healthcare Trust
    London, W2 1PG, United Kingdom
  • Cliniques Universitaires St-Luc
    Bruxelles, 1200, Belgium
  • UZ Gent
    Gent, 9000, Belgium
  • HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke
    Wuppertal, 42283, Germany
  • Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
    Bydgoszcz, 85-030, Poland
  • Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci
    Krakow, 31-202, Poland
  • Med.-Polonia Sp. z o.o. NSZOZ
    Poznan, 60-693, Poland
  • Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci
    Łodz, 91-347, Poland
  • Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive
    Bologna, Emilia-Romagna, 40138, Italy
  • Ospedale Infantile Regina Margherita; Gastroenterologia
    Torino, Piemonte, 10126, Italy
  • Kyiv Children's Clinical Infectious Diseases Hospital
    Kyiv, 01119, Ukraine
  • SI Institute of the pediatrics, obstetrics and gynecology
    Kyiv, 04050, Ukraine
  • Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology
    Sofia, 1612, Bulgaria
  • University Hospital "St. Marine"; Dept. of Pediatrics
    Varna, 9000, Bulgaria
  • Beijing 302 Hospital; No. 2 Infectious Disease Section
    Beijing, 100039, China
  • Beijing You An Hospital; Digestive Dept
    Beijing, 100069, China
  • the First Hospital of Jilin University
    Changchun, 130021, China
  • Southwest Hospital , Third Military Medical University
    Chongqing, 400038, China
  • The Eighth People's Hospital of Guangzhou
    Guangzhou, 510060, China
  • The Third Affiliated Hospital of Sun Yat-Sen University
    Guangzhou, 510630, China
  • The First Affilliated Hospital of Kunming Medical College
    Kunming, 650032, China
  • The 85th Hospital of P.L.A.
    Shanghai, 200235, China
  • Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
    Urumqi (乌鲁木齐), 830000, China
  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
    Wuhan, 430030, China
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    Xi'an, 710061, China
  • Rambam Medical Center
    Haifa, 31096, Israel
  • Hadassah University Hospital - Ein Kerem
    Jerusalem, 9112001, Israel
  • Western Galilee Hospital - Nahariya
    Nahariya, 22100, Israel
  • The Children's Hospital Westmead; Department of Gastroenterology
    Sydney, New South Wales, 2145, Australia
  • Womens and Childrens Hospital; Department of Gastroenterology
    North Adelaide, South Australia, 5006, Australia
  • Royal Children's Hospital; Department of Gastroenterology
    Melbourne, Victoria, 3053, Australia

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT01519960
Phase
Phase 3
Study Type
Interventional
Last Updated
November 8, 2017