- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129489
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
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
Study Overview
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The patient will be withdrawn from the study but will continue follow up until returning to stable inactive disease as define as normalization of liver enzymes and immunoglobulin level in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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Petach Tikva, Israel
- Belinson Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with biochemical and histological remission
Time Frame: 12 month
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biochemical and histological data will be collected during the study
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12 month
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Number of patients who experience Cannabidiol relates adverse events
Time Frame: 12 month
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Adverse events will be recorded during the study
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12 month
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Proportion of patients with flare up of hepatitis
Time Frame: 12 month
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record of disease flare will be collected during the study
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12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-AH-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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