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

• Status: Terminated
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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 care treatment with corticosteroids

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stero Biotechs Ltd.
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

1. Patients with histologically confirmed chronic hepatitis

2. Age ≥18 years

3. Subject able to provide written informed consent

4. Stable disease for 24 months

5. 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.

6. ALT ≤ 30 U/L in men and ≤19 U/L in women

7. IgG < 1450 mg/dL

8. 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 Criteria:

1. Viral Hepatitis (HAV, HBV, HCV)

2. HIV

3. Serious psychiatric or psychological disorders

4. Active consumption of illicit drugs including cannabis or derivatives (at least 1 month before study start)

5. Overlap disease with Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

6. IgG4 related Autoimmune Hepatitis

7. Transplant patients

8. Patients with significant cardiac, respiratory or active malignance disease comorbidities.

9. Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)

10. Cirrhosis

11. Patients treated with corticoids for other indication except Autoimmune Hepatitis

12. Patient that are taking immunomodulatory medications for other indication