EUCTR2005-005816-26-BE进行中（未招募）1 期
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).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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:
- •Creatinine clearance = (140 - age) x weight in kg
- •(72 x serum creatinine)
- •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
- •9) Males and females, ages = 2 - = 18 years of age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
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: 100000004848EUCTR2005-005816-26-GBBristol-Myers Squibb International Corporation64
进行中（未招募）
不适用
A study of Entecavir in Pediatric Patients with Chronic Hepatitis B Virus (HBV) InfectioEUCTR2005-005816-26-Outside-EU/EEABristol-Myers Squibb International Corporation64
进行中（未招募）
1 期
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
进行中（未招募）
1 期
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 disordersEUCTR2020-003372-41-ESSynAgile Corporation24
已完成
不适用
Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance after Multiple Oral Dosing of LY2623091 in Healthy VolunteersKidney failure10038430chronic kidney diseaseNL-OMON36630Eli Lilly32