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Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Study Purpose

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participant is within the approved age range as per labeling recommendations.
  • - Participant is either on existing Epidiolex therapy for treatment of a seizure disorder or is to be started on Epidiolex for treatment of an Food and Drug Administration (FDA)-approved indication.
  • - Participant is willing to refrain from strenuous exercise 48 to 72 hours prior to all study visits with the exception of unscheduled visits.
  • - Any non-pharmacological therapies (e.g., ketogenic diet) must also be stable up to 4 weeks prior to Screening Visit and expected to be stable throughout the duration of the study.

Exclusion Criteria:

  • - Participant is currently using or within 3 months of screening has used recreational or medicinal cannabis, or synthetic cannabinoid-based medications, not including Epidiolex if currently prescribed.
  • - Participant is not planning to abstain from using recreational cannabinoids or medicinal cannabis, or synthetic cannabinoid-based medications during the study.
  • - Female participant is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for 3 months thereafter.
  • - Participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.
  • - Participant has diseases or disorders which are associated with known severe liver fibrosis with a FibroScan score of ≥ 6.5 Kilopascals.
  • - Positive serology panel (including hepatitis B surface antigen and hepatitis C virus antibody) and/or positive human immunodeficiency virus antibody/p24 antigen screens at screening.
  • - Following a physical examination, if the participant has any abnormalities that, in the opinion of the investigator, would prevent the participant from safe participation in the study.
  • - Participant has significantly impaired hepatic function at Screening Visit alanine aminotransferase or aminotransferase > 3 x upper limit of normal (ULN), and total bilirubin > 2 x ULN or international normalized ratio > 1.5.
  • - Participant is planning to have epilepsy surgery or other major surgery within five years.
  • - Participant has or plans to have any medical device implanted that is contraindicated for use with FibroScan, with the investigator consulting with the Sponsor as needed.
  • - Participation in any clinical trial involving an investigational medicinal product within 3 months prior to the Screening Visit or at any point during this study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05044819
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jazz Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
Arms & Interventions

Arms

Experimental: Cannabidiol

Cannabidiol solution 100 milligrams per milliliter (mg/mL) will be administered orally at a dose level of 5 mg/kg/day for 1 week, then increase to 10 mg/kg/day by the participant or their caregiver twice each day (morning and evening).

Interventions

Drug: - Cannabidiol

Oral Cannabidiol solution 100 mg/mL

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Trial Site, Downey, California

Status

Recruiting

Address

Clinical Trial Site

Downey, California, 90242

Clinical Trial Site, Long Beach, California

Status

Not yet recruiting

Address

Clinical Trial Site

Long Beach, California, 90806

Clinical Trial Site, Los Angeles, California

Status

Not yet recruiting

Address

Clinical Trial Site

Los Angeles, California, 90095-1752

Clinical Trial Site, Sacramento, California

Status

Recruiting

Address

Clinical Trial Site

Sacramento, California, 95817

Clinical Trial Site, Loxahatchee Groves, Florida

Status

Recruiting

Address

Clinical Trial Site

Loxahatchee Groves, Florida, 33470

Clinical Trial Site, Miami, Florida

Status

Recruiting

Address

Clinical Trial Site

Miami, Florida, 33136

Clinical Trial Site, Miami, Florida

Status

Recruiting

Address

Clinical Trial Site

Miami, Florida, 33155

Clinical Trial Site, Miami, Florida

Status

Recruiting

Address

Clinical Trial Site

Miami, Florida, 33176

Clinical Trial Site, Orlando, Florida

Status

Recruiting

Address

Clinical Trial Site

Orlando, Florida, 32806

Clinical Trial Site, Tampa, Florida

Status

Recruiting

Address

Clinical Trial Site

Tampa, Florida, 33606

Clinical Trial Site, Atlanta, Georgia

Status

Withdrawn

Address

Clinical Trial Site

Atlanta, Georgia, 30329

Clinical Trial Site, Augusta, Georgia

Status

Not yet recruiting

Address

Clinical Trial Site

Augusta, Georgia, 30912

Clinical Trial Site, Lexington, Kentucky

Status

Recruiting

Address

Clinical Trial Site

Lexington, Kentucky, 40504

Clinical Trial Site, Baltimore, Maryland

Status

Not yet recruiting

Address

Clinical Trial Site

Baltimore, Maryland, 21205

Clinical Trial Site, Boston, Massachusetts

Status

Not yet recruiting

Address

Clinical Trial Site

Boston, Massachusetts, 02114-2743

Clinical Trial Site, New Brunswick, New Jersey

Status

Recruiting

Address

Clinical Trial Site

New Brunswick, New Jersey, 08901

Clinical Trial Site, New York, New York

Status

Not yet recruiting

Address

Clinical Trial Site

New York, New York, 10016

Clinical Trial Site, Asheville, North Carolina

Status

Withdrawn

Address

Clinical Trial Site

Asheville, North Carolina, 28806

Clinical Trial Site, Charlotte, North Carolina

Status

Not yet recruiting

Address

Clinical Trial Site

Charlotte, North Carolina, 28203

Clinical Trial Site, Durham, North Carolina

Status

Recruiting

Address

Clinical Trial Site

Durham, North Carolina, 27708

Clinical Trial Site, Cincinnati, Ohio

Status

Not yet recruiting

Address

Clinical Trial Site

Cincinnati, Ohio, 45219

Clinical Trial Site, Oklahoma City, Oklahoma

Status

Recruiting

Address

Clinical Trial Site

Oklahoma City, Oklahoma, 73104

Clinical Trial Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Clinical Trial Site

Philadelphia, Pennsylvania, 19107

Clinical Trial Site, Charleston, South Carolina

Status

Recruiting

Address

Clinical Trial Site

Charleston, South Carolina, 29425

Clinical Trial Site, Austin, Texas

Status

Recruiting

Address

Clinical Trial Site

Austin, Texas, 78758

Clinical Trial Site, Dallas, Texas

Status

Recruiting

Address

Clinical Trial Site

Dallas, Texas, 75251

Clinical Trial Site, Houston, Texas

Status

Recruiting

Address

Clinical Trial Site

Houston, Texas, 77030-3000

Clinical Trial Site, Round Rock, Texas

Status

Recruiting

Address

Clinical Trial Site

Round Rock, Texas, 78681

Clinical Trial Site, Henrico, Virginia

Status

Recruiting

Address

Clinical Trial Site

Henrico, Virginia, 23226

Clinical Trial Site, Winchester, Virginia

Status

Recruiting

Address

Clinical Trial Site

Winchester, Virginia, 22601

Clinical Trial Site, Crab Orchard, West Virginia

Status

Withdrawn

Address

Clinical Trial Site

Crab Orchard, West Virginia, 25827

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