Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Pediatric Immuno-Tolerant Chronic Hepatitis B
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02263079
Start Date
June 16 2014
End Date
January 29 2020
Last Update
August 24 2020
Active Locations (25)
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1
Children's Mercy Hosp Clinics
Kansas City, Missouri, United States, 64108
2
Columbia University
New York, New York, United States, 10032-3725
3
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Womens and Childrens Hospital; Department of Gastroenterology
North Adelaide, South Australia, Australia, 5006