Status:
TERMINATED
A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis
Lead Sponsor:
Stero Biotechs Ltd.
Conditions:
Autoimmune Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
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 aza...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Viral Hepatitis (HAV, HBV, HCV)
- HIV
- 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)
- Cirrhosis
- Patients treated with corticoids for other indication except Autoimmune Hepatitis
- Patient that are taking immunomodulatory medications for other indication
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04129489
Start Date
February 7 2019
End Date
March 1 2020
Last Update
June 16 2020
Active Locations (1)
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1
Belinson Medical Center
Petah Tikva, Israel