A Phase 2a Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proportion of patients with biochemical and histological remission
研究概览
简要总结
Subjects with stable autoimmune hepatitis disease currently being administered corticosteroids with or without azathioprine (AZA) treatment will be be treated with Cannabidiol instead of standard of care treatment with corticosteroids
详细描述
Patients will be included if they are in stable remission with a prednisone at the lower stable dose to maintain remission with or without azathioprine , Budesonide with or without azathioprine or azathioprine alone for at least 24 months.
Patient will be switch from standard of care to treatment with Cannabidiol for 12 months. They will receive increasing doses of Cannabidiol over a period of one month. Dosage will start at 25 mg Cannabidiol twice a day and will be increased every seven days, if no side effects are observed, to 50 mg, 100 mg and finally to 150 mg Cannabidiol twice a day respectively, as detailed below.
At the end of this month, if the 150 mg twice a day dose level is deemed safe for one week, the standard of care will be stopped at once and patients will continue receiving only Cannabidiol 150 mg twice a day for an additional period of 11 months.
The patient will be offered to undergo liver biopsy in the screening period to prove histological remission along with the biochemical remission (not mandatory for inclusion).
After 12 months of treatment with Cannabidiol all patient will undergo liver biopsy for confirmation of histological remission and then the treatment will be stopped as for physician decision and guidelines of treatment of autoimmune hepatitis disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed chronic hepatitis
- •Age ≥18 years
- •Subject able to provide written informed consent
- •Stable disease for 24 months
- •Currently being administered prednisone (with or without azathioprine) therapy at the lower stable dose to maintain remission or Budesonide (with or without azathioprine) therapy at the lower stable dose to maintain remission or azathioprine alone.
- •ALT ≤ 30 U/L in men and ≤19 U/L in women
- •IgG < 1450 mg/dL
- •Non-pregnant women (via negative pregnancy test) and women with no intention to become pregnant during the term of the trial or three months after cessation of CBD treatment
排除标准
- •Viral Hepatitis (HAV, HBV, HCV)
- •Serious psychiatric or psychological disorders
- •Active consumption of illicit drugs including cannabis or derivatives (at least 1 month before study start)
- •Overlap disease with Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
- •IgG4 related Autoimmune Hepatitis
- •Transplant patients
- •Patients with significant cardiac, respiratory or active malignance disease comorbidities.
- •Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)
- •Patients treated with corticoids for other indication except Autoimmune Hepatitis
- •Patient that are taking immunomodulatory medications for other indication
研究组 & 干预措施
Sintetic Cannabidiol
Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally twice a day
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Proportion of patients with biochemical and histological remission
时间窗: 12 month
biochemical and histological data will be collected during the study
Number of patients who experience Cannabidiol relates adverse events
时间窗: 12 month
Adverse events will be recorded during the study
Proportion of patients with flare up of hepatitis
时间窗: 12 month
record of disease flare will be collected during the study
次要结局
未报告次要终点