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

NCT ID: NCT04129489

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-07
• Study Completion Date: 2020-03-01

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 care treatment with corticosteroids

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 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.

In any case of flare defined as elevation in liver enzymes and immunoglobulins in consecutive blood test the patient will reintroduced for standard of care treatment at a dosage as of investigator decision and the Cannabidiol will be discontinued.

The patient will be withdrawn from the study but will continue follow up until returning to stable inactive disease as define as normalization of liver enzymes and immunoglobulin level in consecutive blood tests.

Conditions

Autoimmune Hepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintetic Cannabidiol

Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally twice a day

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally

Interventions

Cannabidiol

Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stero Biotechs Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Belinson Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

ST-AH-01

Identifier Type: -

Identifier Source: org_study_id