A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response - STOP-NUC

niversität Leipzig0 个研究点目标入组 166 人开始时间: 2014年11月13日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. HBeAg negative chronic hepatitis B (HBsAg positive)
•2. Age = 18 years, male or female
•3. Continuous nucleoside or nucleotide analogue therapy with either mono or combination therapy with adefovir dipivoxil (ADV), lamivudine (LMV), telbivudine (LdT), entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 4 years prior to screening.
•Of note, as in previous observation the rates of HBsAg loss in HBeAg negative patients were comparable during treatment with all the mentioned drugs (Figure 3) we anticipate that the different drug regimes do not represent a factor influencing the response rates after treatment cessation in this trial. However, randomisation will be stratified with respect to the kind of previous therapy (see 8.1.1)
•4. Documented undetectable HBV DNA level during treatment for at least 4 years prior to screening (documented by quantification of HBV DNA at least every 6 months). Please note: In terms of this trial, we define undetectable” as below 1000 copies/mL (172 IU/mL). This comparatively high upper limit of HBV DNA levels was chosen for the definition of response to take into account that assays for HBV DNA quantification with different sensitivity are used in the participating centres.
•5. Undetectable HBV DNA level at screening (analysed by central laboratory, Limbach and partners, Heidelberg)
•6. Normal serum ALT levels < ULN (upper limit of normal) according to the local laboratory
•7. Written informed consent

•1. Compensated or decompensated liver cirrhosis
•2. History of decompensated liver disease
•3. Advanced fibrosis - defined either histologically by Scheuer score = stage 3 (within last year before screening) and/or liver stiffness = 10 kPa by elastography (Fibroscan®) or = 1.5 m/s by Acoustic Radiation Force Impulse (ARFI) (each within 6 months before screening)
•4. Evidence of hepatocellular carcinoma (HCC)
•5. HIV, HDV or HCV co-infection
•6. Iatrogenic or disease-related immunosuppression (e.g. treatment with systemic glucocorticoids, TNFa-antibodies and other immunosuppressive drugs as well as chemotherapy or malignant disorders)
•7. HBV associated extra hepatic manifestations (e.g. glomerulonephritis, panarteriitis nodosa, HBV-associated dermatosis)
•8. Significant alcohol consumption (> 30 g/day for women and > 50 g/day for men)
•9. Pregnant or nursing women
•10. Participation in any other interventional trial
•11. Suspected lack of compliance
•12. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects from the trial medication on contraception)
•13. Patient is incapable to give informed consent

发起方

niversität Leipzig