NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
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 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
CompletedPhase 3
Sponsor: Hoffmann-La Roche
Conditions: Pediatric Immuno-Tolerant Chronic Hepatitis B
Interventions: Entecavir, Lamivudine, Pegylated Interferon Alfa-2A
Countries: United States, Australia, Belgium, Germany, Italy, Malaysia, Romania, Russia
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 overview
Sex: ALL
Age: 3 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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 * 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)
Locations (25)
- Kansas City, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- North Adelaide, South Australia, Australia
- Brussels, Belgium
- Ghent, Belgium
- Essen, Germany
- Mainz, Germany
- München, Germany
- Wuppertal, Germany
- Bologna, Emilia-Romagna, Italy
- Kuala Lumpur, Malaysia
- Bucharest, Romania
- Saint Petersburg, Russia
- Samara, Russia
- Taoyuan County, Taiwan
- Adana, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
- Kyiv, Ukraine
- Birmingham, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom