CompletedPhase IInterventional

Testing a potential new treatment for patients with severe alcohol-associated hepatitis called SZN-043

Alcohol-related hepatitis is serious inflammation of the liver caused by drinking too much alcohol. This early-stage clinical trial is testing a new drug called SZN-043 in people with severe forms of this illness. Doctors want to find out if SZN-043 is safe and how well the body breaks it down. The study drug is given through a drip into a vein over about 30 minutes. Depending on their treatment group, participants will receive one, two, or three doses while being closely looked after in hospital and follow-up clinics. Participants will have tests to check their liver health, including blood tests, simple breath tests, and an ultrasound scan. Taking part may not directly improve a person's condition, but the findings could help researchers develop better treatments for liver disease in the future.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Surrozen

Enrolment target

Start

23 May 2024

Estimated completion

27 Dec 2024

Severe alcohol-associated hepatitis

What is this study about?

Severe alcohol-associated hepatitis is a sudden and life-threatening condition where the liver becomes heavily inflamed due to heavy alcohol use. When this happens, liver cells become damaged and can die off, preventing the liver from doing vital jobs like clearing toxins from the blood. Current treatment options are very limited, meaning new, targeted medicines are urgently needed.

This clinical trial is looking at an experimental drug called SZN-043. SZN-043 is designed to stimulate liver repair and encourage healthy cells to regrow. It has already been tested in healthy volunteers and people with long-term liver scarring. This study is the first time it is being tested specifically in people hospitalised with severe alcohol-related hepatitis.

Because this is a Phase 1 study, the main goal is safety. Researchers need to see how well patients tolerate different doses and how the drug moves through the body. The findings will help doctors understand whether SZN-043 can be developed into an effective future treatment.

Key takeaways

Tests a new medicine, SZN-043, designed to help repair liver tissue.
Open to adults aged 18 and over hospitalised with severe alcohol-related hepatitis.
The medicine is given by an intravenous drip into a vein over 30 minutes.
Involves regular safety checks, blood samples, breath tests, and scans.
Certain medications like paracetamol must be avoided while on the study.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This trial is for adults aged 18 and older who have been admitted to hospital with severe alcohol-related hepatitis. Participants must have developed jaundice (yellowing of the eyes or skin) within the past eight weeks and have a history of heavy drinking before entering the study.

People cannot take part if they have other causes of liver damage, such as chronic viral hepatitis, or if they have had recent treatments with experimental drugs or certain antibody therapies. Anyone with known liver tumours cannot join.

Women who are pregnant or breastfeeding cannot participate, as the effects of the drug on an unborn baby are unknown. Men and women who could have children must agree to use effective contraception throughout the study period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with severe alcohol-related hepatitis.
I have noticed yellowing of my skin or eyes (jaundice) in the last 8 weeks.
I am currently in hospital or due to be admitted for my liver condition.
I am not pregnant or breastfeeding.
I am willing to attend hospital appointments and complete liver monitoring tests.

Answer every question to see your result.

What does participation involve?

Taking part begins while you are being cared for in hospital. You will be placed into one of three groups to receive either one, two, or three doses of SZN-043. The medicine is given as a liquid drip into a vein in your arm, taking about 30 minutes, followed by at least four hours of close monitoring. Once discharged from the hospital ward, you will continue with follow-up outpatient visits at the hospital clinic.

During your visits, staff will collect blood and urine samples and perform an ultrasound scan of your liver. You will also take part in specialized liver tests, such as drinking a harmless flavoured test solution followed by blood checks, and breathing into collection tubes over an hour to measure liver function. You will also fill in questionnaires about how you feel. Some tests require fasting (no food or drinks except water) for a few hours beforehand.

Potential risks and benefits

There is no guarantee that taking part will improve your liver health, but your participation could help researchers create better treatments for others in the future. As SZN-043 is an experimental drug, there are potential risks and side effects. Early studies showed mild temporary increases in liver proteins and occasional mild discomfort during the drip. Serious allergic reactions are rare but possible. Because SZN-043 affects how the liver handles medicines, common painkillers like paracetamol will be restricted for safety. You will be monitored very closely by a medical team at all times, and you have the absolute right to leave the study at any time without your regular medical care being affected.

Locations (8)

Kings College Hospital
Approximate
London, England
St Georges Hospital
City only
London, England
Auckland City Hospital
Approximate
Auckland, New Zealand
Sunshine Coast University Hospital
Approximate
Queensland, Australia
Royal Prince Alfred Hospital
Approximate
New South Wales, Australia
Pusan National University Hospital
Unverified
Busan, Korea, South
Western University
Unverified
London, Canada
University of Alberta
Unverified
Alberta, Canada

Common questions

What is SZN-043?

SZN-043 is an experimental medicine created to help the liver repair itself after severe inflammation caused by alcohol.

Do I have to pay to take part in this study?

No, the study drug and all trial-related tests are provided free of charge to participants.

Can I take paracetamol during the trial?

No. Because the study drug changes how the liver processes certain medications, paracetamol is restricted. The doctors will advise you on safe pain alternatives.

Will taking part cure my liver disease?

There is no guarantee that this treatment will cure or improve your condition, as this is an early study primarily testing the drug's safety.

Can I leave the study if I change my mind?

Yes, taking part is entirely voluntary. You can withdraw at any point without giving a reason, and your regular NHS care will not be affected.

How to find out more

Joshua Koons

CL-0043-1002@surrozen.com +1 (0)650 420 7056 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.