A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
NCT ID: NCT01519960
Last Updated: 2022-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2012-07-11
2021-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A Pegasys
peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
B Untreated Control
No interventions assigned to this group
C Fibrosis non-randomized
peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
Switch
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
Interventions
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peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
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
Eligibility Criteria
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Inclusion Criteria
* Positive HBsAg for more than 6 months
* Positive HBeAg and detectable HBV DNA 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
Exclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition
San Francisco, California, United States
Johns Hopkins Hospital - Pediatric Gastroenterology
Baltimore, Maryland, United States
Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology
Boston, Massachusetts, United States
St. Louis University - Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Womens and Childrens Hospital; Department of Gastroenterology
North Adelaide, South Australia, Australia
Royal Children's Hospital; Department of Gastroenterology
Melbourne, Victoria, Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology
Sofia, , Bulgaria
University Hospital "St. Marine"; Dept. of Pediatrics
Varna, , Bulgaria
Beijing 302 Hospital; No. 2 Infectious Disease Section
Beijing, , China
Beijing You An Hospital; Digestive Dept
Beijing, , China
the First Hospital of Jilin University
Changchun, , China
Southwest Hospital , Third Military Medical University
Chongqing, , China
The Eighth People's Hospital of Guangzhou
Guangzhou, , China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, , China
The First Affilliated Hospital of Kunming Medical College
Kunming, , China
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
Urumqi (乌鲁木齐), , China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke
Wuppertal, , Germany
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Western Galilee Hospital - Nahariya
Nahariya, , Israel
Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive
Bologna, Emilia-Romagna, Italy
Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
Bydgoszcz, , Poland
Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci
Krakow, , Poland
Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci
Lodz, , Poland
SFI Sceintific Research institute of nutrition of RAMS
Moscow, , Russia
SI Sceintific children health center RAMS
Moscow, , Russia
FSI Scientific research Institute of children's infections
Saint Petersburg, , Russia
MC Gepatolog
Samara, , Russia
Kyiv Children's Clinical Infectious Diseases Hospital
Kyiv, , Ukraine
SI Institute of the pediatrics, obstetrics and gynecology
Kyiv, , Ukraine
Birmingham Children'S Hopsital; Liver Unit
Birmingham, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare Trust
London, , United Kingdom
Countries
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References
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Wirth S, Zhang H, Hardikar W, Schwarz KB, Sokal E, Yang W, Fan H, Morozov V, Mao Q, Deng H, Huang Y, Yang L, Frey N, Nasmyth-Miller C, Pavlovic V, Wat C. Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study. Hepatology. 2018 Nov;68(5):1681-1694. doi: 10.1002/hep.30050. Epub 2018 Oct 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-002732-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
YV25718
Identifier Type: -
Identifier Source: org_study_id
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