NCT00071201已完成3 期
A Multi-Center Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B and Varying Degrees of Renal Impairment
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of renal impairment.
详细描述
Approximately 48 patients with chronic hepatitis B will be enrolled into four groups representing varying degrees of renal function. Grouping will be achieved through estimation of creatinine clearance (CLcr) using the Cockcroft-Gault method of calculation at the time of screening:
Group 1: Mild (Clcr = greater than or equal to 50 to less than 80 mL/min)
Group 2: Moderate (Clcr = greater than or equal to 20 to less than 50 mL/min)
Group 3: Severe (Clcr = greater than or equal to 10 to less than 20 mL/min)
Group 4A-B: End stage renal disease (ESRD) including hemodialysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18 through 65 years
- •Able to give written informed consent and comply with the requirements of the study
- •Females of childbearing potential must have a negative serum pregnancy test at screening and must use effective methods of contraception throughout the study.
- •Positive serum HBV DNA equal to or greater than 100,000 copies/mL
- •Patients with abnormal renal function, defined as a calculated creatinine clearance less than 80 mL/min, or end stage renal disease undergoing hemodialysis
- •For non-hemodialysis patients, renal function must be "stable"
- •ALT value equal to or greater than 1.2 to equal to or less than 15 times the upper limit of normal on at least two occasions, or histological evidence of necroinflammation and/or fibrosis
- •Compensated liver disease with the following:
- •Prothrombin time equal to or less than to 1 second above normal range
- •Total bilirubin equal to or less than to 2.5 mg/dL or normal direct bilirubin
- •No history of variceal bleeding or encephalopathy
- •HIV, HCV, and HDV seronegative
- •Adequate hematological function defined as:
- •Absolute neutrophil count equal to or greater than 750/mm3
- •Platelets equal to or greater than 50,000/mm3
- •Hemoglobin equal to or greater than 7.5 g/dL
排除标准
- •Inability to comply with study requirements
- •Lactating or pregnant females
- •History or current manifestations of clinically significant cardiac, respiratory, endocrine (including diabetes mellitus), metabolic, gastrointestinal, dermatological, infectious, malignant, hematological, neurological, rheumatologic or psychiatric disorder, which is not related to the patient's renal insufficiency or deemed by the investigator to preclude suitability for pharmacokinetic assessment or interfere with patient treatment, assessment, or compliance with the protocol
- •Received interferon within 6 months prior to study screening
- •Bone marrow transplant recipients
- •Renal transplant less than 6 months prior to study entry, or clinical evidence of rejection
- •Patients expected to receive organ transplantation within 48 weeks
- •Evidence of active liver disease due to other causes
- •Patients taking chemotherapeutic agents within 2 months or expected to receive these agents during the study
- •Previous participation in an investigational trial involving any investigational compound within 2 months, or within 5 half-lives of the study drug if sooner
- •History of alcohol or drug abuse sufficient to hinder compliance with protocol
- •Child-Pugh-Turcotte score over 9
- •Evidence of hepatic mass suggestive of hepatocellular carcinoma
- •History of malignancy other than basal cell carcinoma or treated cervical carcinoma in situ or cervical dysplasia
- •The use of systemic drugs with potential activity against HBV for a period of more than 12 weeks in duration at any time
- •The use of adefovir dipivoxil for a period of more than 12 weeks in duration at any time. Hemodialysis patients may be enrolled regardless of prior treatment duration with adefovir dipivoxil if treatment completed greater than or equal to 16 weeks before study.
- •Hypersensitivity to nucleoside and/or nucleotide analogs
- •Received hepatotoxic drugs within 2 months or plan to receive them
- •Received nephrotoxic drugs or competitors of renal excretion within 2 months or plan to receive them, except for transplant patients
- •Current use of other pivalic acid containing medications
- •Patients undergoing continuous ambulatory peritoneal dialysis (CAPD)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal UlcerReflux EsophagitisGastric UlcerDuodenal UlcerNCT03553563AstraZeneca50
招募中
3 期
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.MelanomaUnresectable MelanomaMetastatic MelanomaNCT05727904Iovance Biotherapeutics, Inc.670
已完成
3 期
Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAsLeukemia, Myelomonocytic, ChronicMyelodysplastic SyndromesNCT02907359Astex Pharmaceuticals, Inc.417
终止
3 期
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the BladderNon-muscle Invasive Bladder CancerCarcinoma in SituTransitional Cell CarcinomaNCT01310803Endo Pharmaceuticals1
进行中（未招募）
3 期
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)Chronic Myeloid Leukemia, Chronic PhaseNCT03722420Il-Yang Pharm. Co., Ltd.238