Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
NCT ID: NCT00907894
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Stratum 1
LDT600 (Telbivudine)
LDT600 (Telbivudine)
Stratum 2
LDT600 (Telbivudine)
LDT600 (Telbivudine)
Stratum 3
LDT600 (Telbivudine)
LDT600 (Telbivudine)
Interventions
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LDT600 (Telbivudine)
LDT600 (Telbivudine)
Eligibility Criteria
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Inclusion Criteria
* HBsAg seropositive
Exclusion Criteria
* Prior anti-HBV therapy within 30 days of study drug dosing.
2 Years
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Brussels, , Belgium
Novartis Investigator Site
Frankfurt, , Germany
Novartis Investigator Site
Starnberg, , Germany
Novartis Investigator Site
Wuppertal, , Germany
Novartis Investigator Site
Manila, , Philippines
Novartis Investigator Site
Quezon City, , Philippines
Novartis Investigator Site
Birmingham, , United Kingdom
Countries
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References
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Stein DS, Ke J, Uy G, Bosheva M, Qi Y, Praestgaard J; LDT600A2104 Study Team. Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of telbivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother. 2013 Sep;57(9):4128-33. doi: 10.1128/AAC.00117-13. Epub 2013 Jun 17.
Related Links
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Results for CLDT600A2104 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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EudraCT 2007-006218-40
Identifier Type: -
Identifier Source: secondary_id
CLDT600A2104
Identifier Type: -
Identifier Source: org_study_id