Last updated: 11/07/2018 17:57:52
A Phase II, Dose Ranging Study of the Pharmacokinetics of Lamivudine in Children and Adolescents with Chronic Hepatitis B Virus Infection
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase II, Dose Ranging Study of the Pharmacokinetics of Lamivudine in Children and Adolescents with Chronic Hepatitis B Virus Infection
Trial description: A Phase II, Dose Ranging Study of the Pharmacokinetics of Lamivudine in Children and Adolescents with Chronic Hepatitis B Virus Infection
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
A dose ranging study of the pharmacokinetics, safety, and preliminary efficacy of lamivudine in children and adolescents with chronic hepatitis b. Sokal, E. M., Roberts, E. A., Mieli-Vergani, G., McPhillips, P., Johnson, M., Barber, J., Dallow, N., Boxall, E., and Kelly, D. Antimicrob Agents Chemother 2000; 44(3):590-7.
Clinical pharmacokinetics of lamivudine. Johnson, M. A., Moore, K. H., Yuen, G. J., Bye, A., and Pakes, G. E. Clin Pharmacokinet 99; 36(1):41-66
Lamivudine: in children and adolescents with chronic hepatitis b virus infection. Keam, S. J. and Scott, L. J. Paediatr Drugs 2002; 4(10):687-94; discussion 695-6, 687-94.
Medical condition
Hepatitis B, Chronic
Product
lamivudine
Collaborators
Not applicable
Study date(s)
June 1997 to January 1998
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1998-23-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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