EUCTR2021-001003-32-BE进行中（未招募）1 期
Controlled Interruption of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Infections - COIN-B
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •Stop group:
- •= 18 year old and = 75 year old
- •Chronic hepatitis B, defined as HBsAg positive or HBV DNA positive =6 months
- •Start of treatment HBeAg negative
- •Under continuous NA treatment (Lamivudin, Adefovir, Tenofovir or Entecavir)
- •HBV DNA below the local limit of quantification for at least 36 months at cessation or =2log IU/mL for at least 48 months at cessation
- •ALT =2x Upper Limit Normal (ULN) on 2 sequential measurements at least 6 months apart (one of which is at screening)
- •Control Group:
- •= 18 year old and = 75 year old
- •Chronic hepatitis B, defined as HBsAg positive or HBV DNA positive =6 months
- •Start of treatment HBeAg negative
- •Under continuous NA treatment (Lamivudin, Adefovir, Tenofovir or Entecavir) for at least 1 year
- •HBV DNA below the local limit of quantification for at least 6 months at inclusion
- •ALT =2xULN on 2 sequential measurements at least 6 months apart (one of which is at screening)
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Stop group:
- •INR >1.3xULN (unless caused by anticoagulation therapy or vitamin K deficiency) at any point prior to or at the time of screening
- •Total bilirubin >1.2xULN (unless there is documentation of a benign cause such as Gilbert’s disease) at any point prior to or at the time of screening
- •Fibrosis =F3 at pre-treatment start biopsy and/or ever a Fibroscan result >9 kPa and/or ever a ShearWave elastography (SWE) > 8.15 kPa (unless a recent (<6 months old) liver biopsy shows Metavir fibrosis =F2).
- •Active confection: hepatitis C virus (HCV) RNA positive, hepatitis delta virus (HDV) RNA positive, human immunodeficiency virus (HIV) antigen (Ag)-Antibody (Ab) positive
- •Immunocompromised individuals, defined as (in line with the National Health Service (NHS) criteria)
- •oPatients undergoing any radiotherapy or chemotherapy <1 year before study start
- •oSolid organ transplant recipients
- •oBone marrow or stem cell transplant recipients
- •oPatients having multiple myeloma or genetic disorders affecting the immune system
- •oIndividuals receiving immunosuppressive or immunomodulating biological therapy <6 months before study start
- •oPatients receiving protein kinase inhibitors or poly(ADP-ribose) polymerase (PARP) inhibitors
- •oIndividuals treated with steroid sparing agents such as cyclophosphamide and mycophenolate mofetil
- •oIndividuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20 mg or more per day for adults
- •oPatients with a history of haematological malignancy, including leukaemia, lymphoma, and myeloma
- •oPatients with systemic Lupus erythematosus, rheumatoid arthritis, or psoriasis who may require long term immunosuppressive treatments
- •Patients that have either an antecedent of or ongoing HCC
- •Patients with a family history of HCC despite compliance to standard of care follow-up
- •Pregnancy or lactation
- •Planned or recent (<6 months before inclusion) participation in other therapeutic interventional trials
- •Ever participation in HBV small interfering RNA (siRNA) studies
- •Control group:
- •INR >1.3xULN (unless caused by anticoagulation therapy or vitamin K deficiency) at any point prior to or at the time of screening
- •Total bilirubin >1.2xULN (unless there is documentation of a benign cause such as Gilbert’s disease) at any point prior to or at the time of screening
- •Fibrosis =F4 at pre-treatment start biopsy and/or ever a Fibroscan result =11.4 kPa and/or ever a SWE =11.5 kPa (unless a recent (<6 months old) liver biopsy shows Metavir fibrosis •Active confection: HCV RNA positive, HDV RNA positive, HIV Ag-Ab positive
- •Immunocompromised individuals, defined as (in line with the NHS criteria)
- •oPatients undergoing any radiotherapy or chemotherapy <1 year before study start
- •oSolid organ transplant recipients
- •oBone marrow or stem cell transplant recipients
- •oPatients having multiple myeloma or genetic disorders affecting the immune system
- •oIndividuals receiving immunosuppressive or immunomodulating biological therapy <6 months before study start
- •oPatients receiving protein kinase or PARP
- •oIndividuals treated with steroid sparing agents such as cyclophosphamide and mycophenolate mofetil
- •oIndividuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20 mg or more per day for adults
- •oPatients with a history of haematological malignancy, including leukaemia, lymphom
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