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

NCT04129489 | Terminated Phase 2

• 1 other identifier: ST-AH-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with biochemical and histological remission

  biochemical and histological data will be collected during the study

  12 month

• Number of patients who experience Cannabidiol relates adverse events

  Adverse events will be recorded during the study

  12 month

• Proportion of patients with flare up of hepatitis

  record of disease flare will be collected during the study

  12 month

Study Arms (1)

Sintetic Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol

Interventions

Cannabidiol DRUG

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

Sintetic Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stero Biotechs Ltd.: lead

Study Sites (1)

Belinson Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: October 16, 2019
• Study Start: February 7, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

IL (1)