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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

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ClinicalTrials.gov Identifier: NCT04129489
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Stero Biotechs Ltd.

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

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: Cannabidiol Phase 2

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The patient will be withdrawn from the study but will continue follow up until returning to stable inactive disease as define as normalization of liver enzymes and immunoglobulin level in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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of patients with biochemical and histological remission [ Time Frame: 12 month ]
    biochemical and histological data will be collected during the study

  2. Number of patients who experience Cannabidiol relates adverse events [ Time Frame: 12 month ]
    Adverse events will be recorded during the study

  3. Proportion of patients with flare up of hepatitis [ Time Frame: 12 month ]
    record of disease flare will be collected during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sari Sagiv 972528594444 ext 972528594444 sari@mor-research.com

Locations
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Israel
Belinson Medical Center Recruiting
Petach Tikva, Israel
Contact: Assaf Issachar, Dr.       assaf@clalit.org.il   
Sponsors and Collaborators
Stero Biotechs Ltd.

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Responsible Party: Stero Biotechs Ltd.
ClinicalTrials.gov Identifier: NCT04129489     History of Changes
Other Study ID Numbers: ST-AH-01
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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