Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00645294
First received: March 21, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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Purpose
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: Adefovir dipivoxil Drug: Adefovir Dipivoxil |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Phase 1-2 Open-Label Study of the Pharmacokinetics and Safety of a Single Dose of Adefovir Dipivoxil in Children and Adolescents (Aged 2-17) With Chronic Hepatitis B |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | February 2003 |
| Study Completion Date: | August 2003 |
| Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment Group A
ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group
|
Drug: Adefovir dipivoxil
0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8
|
|
Treatment Group B
ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group
|
Drug: Adefovir Dipivoxil
0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8
|
|
Treatment Group C
ADV 10 mg single dose on Day 1 in 12-17 year old age group
|
Drug: Adefovir Dipivoxil
ADV 10 mg on Day 1
|
Detailed Description:
Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following:
- HBsAg positive for a minimum of 6 months
- HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening
- Children and adolescents with compensated liver disease
- ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645294
Locations
| Belgium | |
| Cliniques Universitaries | |
| Bruxelles, Belgium, 1200 | |
| Germany | |
| J.W. Goethe-Universitat | |
| Frankfurt, Germany, D-60590 | |
| Mid. Hochschule Hannover Kinderklinik | |
| Hannover, Germany, D-30625 | |
| Kinderklinik der Gutenberg Universitat | |
| Mainz, Germany, 55101 | |
| Standort Lindwurmstrasse | |
| Munchen, Germany, D-80337 | |
| Zentrum fur Kinder und Jugendmedizin der Klinikum | |
| Wuppertal, Germany, D-42282 | |
| Poland | |
| Oddzial Chorob Infekcyjnych Dzieci | |
| Krakow, Poland, 31-202 | |
| Klinika Gastroenterologii | |
| Warszawa, Poland, 04-730 | |
| United Kingdom | |
| King's College Hospital | |
| London, England, United Kingdom, SE5 9RY | |
| University of Birmingham | |
| Birmingham, United Kingdom, B4 6NH | |
Sponsors and Collaborators
Gilead Sciences
More Information
No publications provided
| Responsible Party: | Elsa Mondou, MD, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00645294 History of Changes |
| Other Study ID Numbers: | GS-02-517 |
| Study First Received: | March 21, 2008 |
| Last Updated: | March 21, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Hepatitis B Adefovir dipivoxil Children Adolescents Pharmacokinetics |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
Hepatitis, Chronic Adefovir Adefovir dipivoxil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on May 19, 2013