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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04129489 |
Recruitment Status :
Terminated
(low recruitment)
First Posted : October 16, 2019
Last Update Posted : June 16, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autoimmune Hepatitis | Drug: Cannabidiol | Phase 2 |
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The patient will be withdrawn from the study but will continue follow up until returning to stable inactive disease as define as normalization of liver enzymes and immunoglobulin level in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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | February 7, 2019 |
Actual Primary Completion Date : | March 1, 2020 |
Actual Study Completion Date : | March 1, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Sintetic Cannabidiol
Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally twice a day
|
Drug: Cannabidiol
Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally |
- Proportion of patients with biochemical and histological remission [ Time Frame: 12 month ]biochemical and histological data will be collected during the study
- Number of patients who experience Cannabidiol relates adverse events [ Time Frame: 12 month ]Adverse events will be recorded during the study
- Proportion of patients with flare up of hepatitis [ Time Frame: 12 month ]record of disease flare will be collected during the study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129489
Israel | |
Belinson Medical Center | |
Petach Tikva, Israel |
Responsible Party: | Stero Biotechs Ltd. |
ClinicalTrials.gov Identifier: | NCT04129489 |
Other Study ID Numbers: |
ST-AH-01 |
First Posted: | October 16, 2019 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis A Hepatitis Hepatitis, Autoimmune Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepatitis, Chronic Autoimmune Diseases Immune System Diseases Epidiolex Anticonvulsants |