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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04129489
• Date of registration: 18/03/2019
• Prospective Registration: No
• Primary sponsor: Stero Biotechs Ltd.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: February 7, 2019
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04129489
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Israel

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Hepatitis

Intervention(s)

Drug: Cannabidiol

Primary Outcome(s)

Number of patients who experience Cannabidiol relates adverse events [Time Frame: 12 month]

Proportion of patients with biochemical and histological remission [Time Frame: 12 month]

Proportion of patients with flare up of hepatitis [Time Frame: 12 month]

Secondary ID(s)

ST-AH-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors