Cannabidiol for Chronic Liver Injury Prevention

Not currently recruiting at 27 trial locations

Overseen By Medical Enquiries

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: GW Research Ltd

Must be taking: Epidiolex

Must not be taking: Cannabis, Synthetic cannabinoids

Disqualifiers: Pregnancy, Liver fibrosis, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week initial, then ongoing

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cannabidiol, a compound from cannabis, can prevent chronic liver injury and liver fibrosis (scarring of the liver) in people using it for seizure disorders. Participants will take a cannabidiol oral solution and have their liver health monitored. This study might suit individuals already using Epidiolex (a cannabidiol product) for seizures, who can avoid intense exercise before study visits and are not using other cannabis products. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not use recreational or medicinal cannabis, or synthetic cannabinoid-based medications other than Epidiolex. Any non-drug therapies, like a ketogenic diet, should be stable before and during the study.

What is the safety track record for Cannabidiol?

Research shows that cannabidiol (CBD) might affect the liver in some cases. Studies have produced mixed results about liver enzyme levels, which indicate liver health. Some reports suggest that CBD could raise liver enzyme levels, but the data is inconsistent, especially at the lower doses used in this trial.

For instance, one review mentioned possible liver harm with CBD use but also noted varying results. On the positive side, some research suggests that CBD might protect the liver from certain toxins, indicating both risks and benefits for liver health.

Since this study is in a later phase, CBD has already undergone extensive safety testing. It is generally considered safe to use, although researchers continue to investigate specific effects like those on the liver.

Before joining a trial, discussing any concerns with a healthcare provider is advisable. They can offer advice based on personal health needs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for chronic liver injury, which often involve lifestyle changes, medications to manage symptoms, or even surgery, cannabidiol (CBD) offers a novel approach. Researchers are excited about CBD because it utilizes a natural compound derived from cannabis, known for its anti-inflammatory and antioxidant properties, which could directly protect liver cells from damage. Additionally, CBD's potential to modulate the immune response makes it a promising candidate for not only preventing further liver injury but potentially improving overall liver function. This unique mechanism of action sets it apart as a potential game-changer in liver health management.

What evidence suggests that cannabidiol might be an effective treatment for chronic liver injury?

Research suggests that cannabidiol (CBD), which participants in this trial will receive, might help protect the liver. One study found that CBD improved liver health in mice by reducing stress-related liver damage. Another study showed that using cannabis, which contains CBD, was linked to a lower risk of liver disease. Additionally, CBD has prevented the activation of cells that cause liver scarring. These findings suggest that CBD could help prevent liver damage and reduce liver scarring. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Lennox Gastaut Syndrome, Dravet Syndrome, or Tuberous Sclerosis who are already taking or starting Epidiolex (cannabidiol) therapy. They must avoid heavy exercise before visits and maintain stable non-drug therapies. Exclusions include recent cannabis use, planned major surgery within five years, pregnancy, significant health risks as determined by the investigator, participation in other drug trials within three months prior to screening, certain liver conditions or diseases that cause liver fibrosis.

Inclusion Criteria

I have been on a stable non-drug therapy, like a special diet, for at least 4 weeks.

I am currently taking or will start taking Epidiolex for seizures.

Participant is willing to refrain from strenuous exercise 48 to 72 hours prior to all study visits with the exception of unscheduled visits.

Exclusion Criteria

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.

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.

I plan to undergo epilepsy or major surgery within the next five years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cannabidiol oral solution starting at 5 mg/kg/day for 1 week, then increasing to 10 mg/kg/day

1 week initial, then ongoing

Monitoring

Participants are monitored for potential chronic liver injury and liver fibrosis

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The study is monitoring participants treated with cannabidiol oral solution for chronic liver injury and liver fibrosis. Cannabidiol is being tested for its long-term safety on the liver among those using it to manage seizures related to specific syndromes.

How Is the Trial Designed?

Group I: Cannabidiol Experimental Treatment 1 Intervention

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).

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

GW Research Ltd

Lead Sponsor

Trials

36

Recruited

3,200+

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Jazz Pharmaceuticals Research UK Limited

Industry Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

A study involving 30 subjects with varying degrees of hepatic impairment showed that a single 200-mg dose of cannabidiol (CBD) was rapidly absorbed, with the time to maximum plasma concentration ranging from 2 to 2.8 hours across all groups.

Significantly increased exposure to CBD was observed in subjects with moderate (2.45 times) and severe (5.15 times) hepatic impairment compared to those with normal liver function, indicating that dose adjustments are necessary for these patients, while CBD was well tolerated with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment. Taylor, L., Crockett, J., Tayo, B., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10888697/

The Role of Cannabidiol in Liver Disease: A Systemic Review All these data indicate that CBD is a promising agent for the treatment of liver disease. More and more evidence shows that cannabinoid ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2836267

Cannabidiol and Liver Enzyme Level Elevations in Healthy ... The most common adverse events in the CBD group were hepatic enzyme increase (11%), eosinophilia (9%), somnolence (8%), and diarrhea (8%) while ...

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1567210/full

The protective role of cannabidiol in stress-induced liver ... Results: CBD exhibited significant protective effects against stress-induced liver injury in mice. Decreases in liver function indicators (including Aspartate ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jgh.16730

Clinical guidance for cannabidiol‐associated ... Another study found that the consumption of cannabis was associated with reduced incidence of liver disease and improvement in liver disease ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0278691524000838

Cannabidiol regulates the activation of hepatic stellate ... The results showed that CBD effectively inhibited the proliferation and activation of HSC-T6 and LX-2 cells, and reduced the production of profibrotic factors ...

6. fda.gov fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trial

CDER Investigators Address the Safety of CBD in a ... Liver safety data are limited for lower CBD doses and inconsistent regarding the occurrence and severity of liver enzyme elevations at 200-400 ...

7. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Potential risks and harms associated with CBD use include adverse drug interactions, liver toxicity, and reproductive and developmental effects. ○ Delta-9 THC ...