A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

NCT01519960 | Completed Phase 3 Results

• 2 other identifiers: YV257182011-002732-70
• Study Type: interventional
• Target: 165
• Locations: 12 countries
• Sites: 39

Brief 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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B

  HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

  FU Week 24 (up to 72 weeks overall)

Secondary Outcomes (72)

• Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B

  FU Week 24 (up to 72 weeks overall)

• Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B

  FU Week 24 (up to 72 weeks overall)

• Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B

  FU Week 24 (up to 72 weeks overall)

• Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B

  FU Week 24 (up to 72 weeks overall)

• Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

  FU Week 24 (up to 72 weeks overall)

Study Arms (4)

A Pegasys

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]

B Untreated Control

NO INTERVENTION

C Fibrosis non-randomized

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]

Switch

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa-2a [Pegasys] DRUG

Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48

A Pegasys; C Fibrosis non-randomized

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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 may not qualify 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (39)

Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition

San Francisco, California, 94143, United States

Location

Johns Hopkins Hospital - Pediatric Gastroenterology

Baltimore, Maryland, 21287-5554, United States

Location

Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology

Boston, Massachusetts, 02115, United States

Location

St. Louis University - Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Womens and Childrens Hospital; Department of Gastroenterology

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital; Department of Gastroenterology

Melbourne, Victoria, 3053, Australia

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology

Sofia, 1612, Bulgaria

Location

University Hospital "St. Marine"; Dept. of Pediatrics

Varna, 9000, Bulgaria

Location

Beijing 302 Hospital; No. 2 Infectious Disease Section

Beijing, 100039, China

Location

Beijing You An Hospital; Digestive Dept

Beijing, 100069, China

Location

the First Hospital of Jilin University

Changchun, 130021, China

Location

Southwest Hospital , Third Military Medical University

Chongqing, 400038, China

Location

The Eighth People's Hospital of Guangzhou

Guangzhou, 510060, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

Location

The First Affilliated Hospital of Kunming Medical College

Kunming, 650032, China

Location

Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

Urumqi (乌鲁木齐), 830000, China

Location

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

Wuhan, 430030, China

Location

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, 710061, China

Location

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

Wuppertal, 42283, Germany

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Western Galilee Hospital - Nahariya

Nahariya, 22100, Israel

Location

Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive

Bologna, Emilia-Romagna, 40138, Italy

Location

Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii

Bydgoszcz, 85-030, Poland

Location

Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci

Krakow, 31-202, Poland

Location

Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci

Lodz, 91-347, Poland

Location

SFI Sceintific Research institute of nutrition of RAMS

Moscow, 115446, Russia

Location

SI Sceintific children health center RAMS

Moscow, 119991, Russia

Location

FSI Scientific research Institute of children's infections

Saint Petersburg, 197022, Russia

Location

MC Gepatolog

Samara, 443100, Russia

Location

Kyiv Children's Clinical Infectious Diseases Hospital

Kyiv, 01119, Ukraine

Location

SI Institute of the pediatrics, obstetrics and gynecology

Kyiv, 04050, Ukraine

Location

Birmingham Children'S Hopsital; Liver Unit

Birmingham, B4 6NH, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Imperial College Healthcare Trust

London, W2 1PG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29689122 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: January 27, 2012
• Study Start: July 11, 2012
• Primary Completion: July 9, 2015
• Study Completion: October 18, 2021
• Last Updated: November 18, 2022
• Results First Posted: August 17, 2016

Record last verified: 2022-10

Locations

GB (3); RU (4); DE (1); AU (2); IT (1); UA (2); IL (3); BE (2); CN (10); BU (2); US (6); PL (3)