EUCTR2009-016357-17-DE
Active, not recruiting
Phase 1
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) versus Placebo in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-PositiveRevised Protocol 02 Incorporates Administrative Letters 1 and 2, and Amendment 05
ConditionsCHRONIC HEPATITIS B VIRUS,PEDIATRICMedDRA version: 14.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsBaraclude
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- CHRONIC HEPATITIS B VIRUS,PEDIATRIC
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Signed Written Informed Consent
- •a) Freely given informed consent must be obtained prior to clinical trial
- •participation, including informed consent for any screening procedures conducted
- •to establish subject eligibility for the trial. 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 Appendix 1\);
- •2\) Target Population
- •a) History of CHB infection defined as HBsAg\-positive at the Screening visit and on
- •at least one other occasion \= 24 weeks prior to screening;
- •b) Detectable HBeAg AND no detectable anti\-HBe antibodies at screening and at
Exclusion Criteria
- •1\) Sex and Reproductive Status
- •a) 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 last dose of
- •investigational product;
- •b) WOCBP using a prohibited contraceptive method. At this time there are no
- •known contraindicated contraceptives to entecavir;
- •c) Women who are pregnant or breastfeeding;
- •d) Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration;
- •e) Sexually active fertile men not using effective birth control if their partners are
Outcomes
Primary Outcomes
Not specified
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