German Acute Hepatitis B Study: a double-blind placebo-controlled randomised two-armed parallel-group phase IIb multi-centre trial

niversity of Leipzig (Germany)0 个研究点目标入组 35 人开始时间: 2007年2月22日最近更新: 2019年5月27日

适应症

试验速览

•1. Known or obvious pre-existing liver disease
•2. Ongoing interferon therapy or stop of interferon less than 3 months ago
•3. Ongoing drug abuse
•4. HIV positive
•5. Anti-HCV or HCV-RNA positive
•6. Anti-HDV positive
•7. Renal insufficiency (creatinine >1.5mg/dl or 135µmol/l)
•8. Pregnant or nursing women
•9. Women with child bearing potential (< 2 years after last menstruation) without effective contraception
•10. Use of oral contraception
•11. Patient with transplanted organs
•12. Any disease requiring immunosuppressive therapy, incl. cancer chemotherapy
•13. Any acute infectious disease requiring administration of sulphonamide/ trimethoprim
•14. Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
•15. Known hypersensitivity to any of the study drugs or its ingredients
•16. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
•17. Expected low compliance (e.g. by travel distance to trial site)

发起方

niversity of Leipzig (Germany)