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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT02263079•Hoffmann-La Roche

View on ClinicalTrials.gov

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. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED

Eligibility

Age

3 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)

Exclusion Criteria

•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
+1 more criteria

Locations (25)

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

Key Dates

Start Date

June 16, 2014

Primary Completion Date

January 29, 2020

Completion Date

January 29, 2020

Last Updated

August 24, 2020

Enrollment

ACTUAL participants

Conditions

Pediatric Immuno-Tolerant Chronic Hepatitis B

Interventions

Entecavir

DRUG

Lamivudine

DRUG

Pegylated Interferon Alfa-2A

DRUG