EUCTR2005-005816-26-Outside-EU/EEA
Active, not recruiting
Not Applicable
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. Revised Protocol 03, incorporating Protocol Amendment 06
DrugsBaraclude
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Signed written informed consent. Minor’s parents or legally acceptable representatives must give fully informed written consent. Assent should be obtained when the minor is judged to be of an age of reason (see Protocol Appendix 1\);
- •2\) LVD\-naïve subjects (\< 1 week of prior LVD therapy, with no LVD therapy within
- •24 weeks prior to enrollment);
- •3\) LVD\-experienced subjects (defined as \> 12 weeks of prior LVD therapy);
- •4\) HBeAg\-positive and HBeAb\-negative at screening and at least once \= 4 weeks prior to screening;
- •5\) Detectable HBsAg at screening and for at least 24 weeks prior to screening;
- •6\) Subjects must have compensated liver function and normal renal function and must meet ALL of the following criteria;
- •\- International Normalization Ratio (INR) \= 1\.5
- •\- Serum albumin \= 3 g/dL (\= 30 g/L)
- •\- Serum bilirubin \= 2\.5 mg/dL (\= 42\.75 µmol/L)
Exclusion Criteria
- •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 6 weeks after the study;
- •2\) WOCBP using a prohibited contraceptive method. At this time there are no known
- •contraindicated contraceptives to entecavir1;
- •3\) Women who are pregnant or breastfeeding;
- •4\) Women with a positive pregnancy test on enrollment or prior to study drug
- •administration;
- •5\) Evidence of variceal bleeding; hepatic encephalopathy; or ascites requiring diuretics or paracentesis, or hepato\-renal syndrome;
- •6\) Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
- •hepatitis D virus (HDV);
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
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. Revised Protocol 02, incorporating Protocol Amendment 01 (v1.0, date 18-Apr-2008), and Protocol Amendment 04 (v1.0, date 05-Dec-2008).Chronic Hepatitis B Virus (HBV) InfectionMedDRA version: 8.1Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)EUCTR2005-005816-26-BEBristol-Myers Squibb International Corporation64
Active, not recruiting
Phase 1
A study of Entecavir in Pediatric Patients with Chronic Hepatitis B Virus (HBV) InfectioChronic Hepatitis B Virus (HBV) InfectionMedDRA version: 16.1 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2005-005816-26-GBBristol-Myers Squibb International Corporation64
Active, not recruiting
Phase 1
Investigating the DopaFuse® Delivery System in Parkinson's Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body.EUCTR2020-003372-41-ITSynAgile Corporation24
Active, not recruiting
Phase 1
Investigating the DopaFuse® Delivery System in Parkinson’s Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body.Motor symptoms in Parkinson’s Disease.MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2020-003372-41-ESSynAgile Corporation24
Completed
Not Applicable
Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance after Multiple Oral Dosing of LY2623091 in Healthy Volunteerschronic kidney diseaseKidney failure10038430NL-OMON36630Eli Lilly32