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

  • Hepatitis B Virus
Trial Status:

Completed

This trial runs in
Cities
  • Adana
  • Ankara
  • Arkhangelsk
  • Bangalore
  • Bangkok
  • Beer Sheva
  • Bergamo
  • Bhubaneshwar
  • Birmingham
  • Bologna
  • Bruxelles
  • București
  • Cairo Governorate
  • Ciudad de Guatemala
  • Cluj-Napoca
  • Dnipropetrovsk
  • Essen
  • Gaziantep
  • Gent
  • Haifa
  • Houston
  • Hyderabad
  • Iasi
  • Jerusalem
  • Kansas City
  • Kolkata
  • Kuala Lumpur
  • Kyiv
  • Leeds
  • London
  • Maharashtra
  • Mainz
  • Manchester
  • Melbourne
  • Menoufiya
  • Moscow
  • München
  • New York
  • North Adelaide
  • Padova
  • Philadelphia
  • Pune
  • Saint-Petersburg
  • Samara
  • San Francisco
  • Santo Domingo
  • Seoul
  • Singapore
  • Starnberg
  • São Paulo
  • Taipei City
  • Taoyuan County
  • Timisoara
  • Vinnytsia
  • Wuppertal
  • Zerifin
Trial Identifier:

NCT02263079 2006-000977-31 NV25361

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02263079 , NV25361 , 2006-000977-31 Trial Identifier
      Entecavir, Lamivudine, Pegylated Interferon Alfa-2A Treatments
      Hepatitis B, Chronic Condition
      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

      Eligibility Criteria

      All Gender
      ≥ 3 Years & ≤ 17 Years Age
      No 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
      • 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)

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