A study of Entecavir in Pediatric Patients with Chronic Hepatitis B Virus (HBV) Infectio
- Conditions
- Chronic 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]
- Registration Number
- EUCTR2005-005816-26-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 64
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)
- Creatinine Clearance (CrCl) = 90 mL/min.
i) For subjects = 17 years of age: To estimate CrCl from a serum creatinine, use
the patient's height (cm), and a proportionality constant using the Schwartz
method:
CrCl = (k * Ht) / Cr
*For boys 2 to < 13 years of age: k = 0.55; For boys > = 13 to = 17 years of
age: k = 0.70; for all girls = 17 years of age: k = 0.55
ii) For subjects 18 years of age, estimated CrCl is calculated using the
Cockcroft-Gault equation as follows:
In men:
Creatinine clearance = (140 - age) x weight in kg
(72 x serum creatinine)
In women:
Creatinine clearance = (140 - age) x weight in kg x 0.85
(72 x serum creatinine)
7) HBV DNA = 100 000 copies/mL at screening and evidence of the presence of Hepatitis B DNA at least once = 4 weeks prior to screening;
8) ALT 2 - 10 × the ULN at screening and at least twice during the 24 weeks prior to
screening, with no value falling within the normal reference range in the intervening
period;
9) Males and females, ages = 2 - = 18 years of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 64
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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);
7) Liver transplant recipients;
8) Recent history of pancreatitis (within 24 weeks prior to the first dose of study
medication);
9) Currently, abusing illegal drugs or alcohol sufficient in the Investigator’s opinion, to
prevent adequate compliance with study therapy or to increase the risk of
hepatotoxicity or pancreatitis;
10) The presence of current malignancy, including HCC, is to be excluded by screening and evaluation practices standard in the country of enrollment;
11) Other serious medical conditions that might preclude completion of this study;
12) Hemoglobin < 10.0 g/dL;
13) Platelet count < 70,000/mm³;
14) Absolute neutrophil count < 1500 cells/mm³;
15) Serum alpha fetoprotein level > 100 ng/mL. If the alpha fetoprotein level is between 21 and 100 ng/mL, it must be repeated. If the repeat alpha fetoprotein level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma, the subject may be dosed in the study;
16) Known history of allergy to nucleoside analogues;
17) Prior exposure to Emtricitabine (FTC);
18) Concomitant medications which may cause immunosuppression, nephrotoxicity or hepatotoxicity or affect renal excretion or hepatic metabolism are not permitted in this study. (See
Protocol Section 5.5.1 for examples);
19) During the ETV treatment phase of the study, a subject may not be co-enrolled in
another clinical trial where an investigational drug is administered;
20) Children that are currently breastfeeding, or those who were breastfed while their mother received LVD; maternal LVD treatment during pregnancy;
21) Unable to tolerate oral medication;
22) Poor peripheral venous access;
23) Prisoners or subjects who are compulsorily detained.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method