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Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
This study is ongoing, but not recruiting participants.
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00095121
  Purpose

The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18) compared to placebo following 48 weeks of treatment.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Adefovir Dipivoxil,
Phase III

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines Adefovir dipivoxil Adefovir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • To investigate the efficacy of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 < 18) compared to placebo following 48 weeks of treatment. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 < 18) compared to placebo following 48 weeks of treatment. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 173
Study Start Date: June 2004
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adefovir Dipivoxil,
    10 mg tablet or oral suspension, 2 mg/mL
Detailed Description:

To investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18) compared to placebo following 48 weeks of treatment. To evaluate the proportion of children and adolescents who experience HBeAg and HBsAg seroconversion following 48 weeks of adefovir dipivoxil or placebo. To evaluate the development of conserved-site mutations associated with resistance to adefovir dipivoxil. To evaluate the long-term safety and efficacy in children and adolescents over an additional 4-year follow-up period including assessment of growth and renal function.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

The criteria listed below are only the main inclusion or exclusion criteria (due to limited posting capacity), a complete list will be provided by the study officials.

Key Inclusion Criteria:

  • Positive HBsAg equal to or greater than 6 months prior to screening and positive HBeAg at screening.
  • Serum HBV DNA greater than or equal to 1 x 100,000 copies/mL (PCR assay) at initial or confirmatory screening visit.
  • Serum ALT levels greater than or equal to 1.5 x ULN at both initial and confirmatory screening visits.
  • Compensated liver disease with anticipated survival greater than 12 months and with the following laboratory and clinical parameters within 4 weeks of baseline: *Prothrombin time less than or equal to 1 second above normal range. *Total bilirubin less than 1.3 mg/dL or normal direct bilirubin. *Serum albumin greater than 3 g/dL (greater than 30 g/L). *No clinical history of ascites, variceal bleeding, encephalopathy or splenomegaly. *Adequate renal function defined as creatinine clearance greater than or equal to 80 mL/min.

Key Exclusion Criteria:

  • Received immunoglobulin, interferon or lamivudine therapy within 6 months prior to initial screening visit.
  • Participated in any investigational trial with any investigational compound within 2 months prior to initial screening.
  • Organ or bone marrow transplant recipients.
  • Clinical evidence of decompensated liver disease.
  • A Child-Pugh-Turcotte score greater than 6.
  • Inability to comply with study requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095121

Locations
United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Elsa Mondou, MD Gilead Sciences
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Study Results  This link exits the ClinicalTrials.gov site

Publications:
Sokal, E, Kelly, D, et al. The Pharmacokinetics (PK) and Safety of a Single Dose of Adefovir Dipivoxil (ADV) in Children and Adolescents (Aged 2-17) with Chronic Hepatitis B. JHepatol,Vol 40(Suppl 1), P. 132, 2004.

Responsible Party: Harvard University ( Maureen Jonas )
Study ID Numbers: GS-US-103-0518
Study First Received: October 29, 2004
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00095121  
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis B
Children
Pediatric
Adefovir Dipivoxil

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis B
Hepatitis, Viral, Human
Adefovir dipivoxil
DNA Virus Infections
Adefovir

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009