Trials / Completed
CompletedNCT00423891
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entecavir | Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response |
Timeline
- Start date
- 2007-06-30
- Primary completion
- 2013-08-31
- Completion
- 2017-09-04
- First posted
- 2007-01-18
- Last updated
- 2018-05-02
- Results posted
- 2014-08-07
Locations
19 sites across 8 countries: United States, Argentina, Belgium, Brazil, Canada, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00423891. Inclusion in this directory is not an endorsement.