EUCTR2008-000733-21-FR进行中（未招募）不适用
A randomized, double blind, multicenter study evaluating efficacy and safety of Clevudine monotherapy versus Tenofovir monotherapy versus combination therapy of Clevudine and Tenofovir for 96 weeks in HBeAg negative patients with chronic hepatitis B, naïve to anti-VHB therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ANRS
- 入组人数
- 150
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
- •Inclusion Criteria
- •1. Male and female patients ? 18 years of age
- •2. Chronic hepatitis B, HBs Ag-positive for ? 6 months, anti HBs negative
- •3. Patients with HBeAg- negative chronic hepatitis B (CHB) and anti HBe positive at screen
- •4. Patients naïve to anti-HBV nucleoside or nucleotide therapy and any other experimental nucleoside/nucleotide analog for HBV
- •5. Serum HBV-DNA quantifiable at ? 2000 IU/mL at screening
- •6. ALT = 1.25 ULN and = 10 ULN
- •7. Liver biopsy (baseline or within prior 6 months) with evidence of chronic hepatic inflammatory injury (Metavir Activity score = 1, Knodell necroinflammatory score = 3, Ishak score = 1)
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Cirrhosis or bridging fibrosis on liver fibrosis
- •2. Subjects who have received any form of alpha interferon in the past 6 months prior to the first administration of randomized treatment
- •3. Any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids and radiation) ? 6 months prior to the first dose of randomized treatment and during the study (except for ? 10 days of acyclovir for herpetic lesions, or prednisone = 10 mg/days for = 10 days more than 1 month)
- •4. Women with ongoing pregnancy or breast feeding
- •5. Positive test at screening for anti-HAV IgM Ab, anti-HIV Ab, anti-HCV Ab, HCV RNA, anti-HDV Ab
- •6. History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease including Wilson’s disease and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, toxic thalassemia, NASH)
- •7. History or other evidence of bleeding from oesophageal varices or other clinical conditions consistent with decompensated liver disease (defined by one of the following criteria being met : serum albumin < 3.5 g/L, prothrombin time > 4 seconds prolonged, serum bilirubin > 34 µmol/L, history of encephalopathy, history of ascites)
- •8. Neutrophil count < 1200 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
- •9. Serum creatinine level > 130µmol/l or calculated creatinine clearance < 70 ml/min (Cockcroft-Gault)
- •10. Evidence or history of tubular nephropathy , Fanconi syndrom or hypophosphoremia
- •11. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- •12. History of a severe seizure disorder or current anticonvulsant use
- •13. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
- •14. History of major organ transplantation with an existing functional graft
- •15. History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •16. Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is ? 20 % within 2 years.
- •17. Patients with a value of alpha-fetoprotein > 100 ng/mL are excluded, unless stability (less than 10 % increase) has been documented over at least the previous 3 months
- •18. Patients included in another trial within 8 weeks prior to screening
- •19. Inability or unwillingness to provide informed consent or abide by the requirements of the study
研究者
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