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

Completed · Phase 3

Conditions studied: Pediatric Immuno-Tolerant Chronic Hepatitis B

In brief

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

Key facts

Study ID: NCT02263079
Run by: Hoffmann-La Roche
People needed: 62
Starts: 2014-06-16
Expected to finish: 2020-01-29
Last updated by the study team: 2020-08-24

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 may not qualify 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)

Where it is running

Children's Mercy Hosp Clinics — Kansas City, Missouri, United States
Columbia University — New York, New York, United States
The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Womens and Childrens Hospital; Department of Gastroenterology — North Adelaide, South Australia, Australia
Cliniques Universitaires St-Luc — Brussels, Belgium
UZ Gent — Ghent, Belgium
Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II — Essen, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin — Mainz, Germany
Dr. von Haunerschen Kinderspital, Kinderchirurgische Klinik und Poliklinik — München, Germany
HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke — Wuppertal, Germany
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive — Bologna, Emilia-Romagna, Italy
University Malaya Medical Center; Department of Paediatrics — Kuala Lumpur, Malaysia
Grigore Alexandrescu Emergency Clinical Hospital for Children — Bucharest, Romania
FSI Scientific research Institute of children's infections — Saint Petersburg, Russia
MC Gepatolog — Samara, Russia
Chang-Gung Memorial Hospital-Linkou; Division of Pediatric Gastroenterology, Dept Pediatrics — Taoyuan County, Taiwan
Cukurova University Medical School Department of Pediatrics; Pediatric Infectious Diseases — Adana, Turkey (Türkiye)
Ankara University School of Medicine, Pediatrics Department; Pediatric Gastroenterology — Ankara, Turkey (Türkiye)
Hacettepe Uni , School of Medicine; Gastroenterology — Ankara, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi Pediyatri Anabilim Dalı; Pediyatrik Gastroenteroloji — Ankara, Turkey (Türkiye)
SI Institute of the pediatrics, obstetrics and gynecology — Kyiv, Ukraine
Birmingham Children'S Hopsital; Liver Unit — Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom
Kings College Hospital NHS Foundation Trust — London, United Kingdom
North Manchester General Hospital — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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