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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
Sponsor:
Information provided by (Responsible Party):
Stero Biotechs Ltd.

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE October 16, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE February 7, 2019
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Hepatitis
Intervention  ICMJE Drug: Cannabidiol
Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally
Study Arms  ICMJE Experimental: Sintetic Cannabidiol
Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally twice a day
Intervention: Drug: Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 14, 2020)
2
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2019)
15
Actual Study Completion Date  ICMJE March 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04129489
Other Study ID Numbers  ICMJE ST-AH-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stero Biotechs Ltd.
Study Sponsor  ICMJE Stero Biotechs Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stero Biotechs Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP