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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
Infectious Diseases Hepatitis B Virus
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT02263079, NV25361, 2006-000977-31
Condition
Hepatitis B, Chronic
Official Title
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
Study 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 Criteria
All
≥ 3 Years & ≤ 17 Years
No
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)
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS_NV25361_final results_March2021_Chinese
(PDF, 0.6 MB)
LPS_NV25361_final results_March2021_English
(PDF, 0.6 MB)
LPS_NV25361_final results_March2021_Italian
(PDF, 0.6 MB)
LPS_NV25361_final results_March2021_Spanish_Latin America
(PDF, 0.6 MB)
LPS_NV25361_final results_July2021_Dutch
(PDF, 0.6 MB)
LPS_NV25361_final results_July2021_French_Belgium
(PDF, 0.6 MB)
LPS_NV25361_final results_March2021_Turkish
(PDF, 0.6 MB)
LPS_NV25361_final results_March2021_German
(PDF, 0.6 MB)
LPS_NV25361_final results_March2021_Romanian
(PDF, 0.5 MB)
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For the latest version of this information please go to www.forpatients.roche.com