RecruitingPHASE2INTERVENTIONAL

A-TANGO Phase 2 Study

This research study, called A-TANGO, is looking into new treatments for a serious liver condition called Acute-on-Chronic Liver Failure (ACLF), often linked to severe alcoholic hepatitis. ACLF is when someone with existing liver disease suddenly gets much sicker, with their liver and possibly other organs struggling to work. The study is testing two new medicines, TAK-242 and G-CSF, alongside standard care. TAK-242 aims to calm down the body's over-reaction (immune system), while G-CSF might help liver cells to grow. Researchers want to find out if this combination is safe and more effective than standard treatment alone for improving liver function and overall health in these patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Yaqrit Ltd

Enrolment target

Start

29 Jun 2026

Estimated completion

31 Dec 2028

Acute-On-Chronic Liver Failure Alcoholic Hepatitis Liver Cirrhosis, Alcoholic

What is this study about?

This study is for people who have a serious liver condition called Acute-on-Chronic Liver Failure (ACLF). This happens when someone already has a long-term liver problem, like scarring (cirrhosis), and then suddenly their liver gets much worse. It's often linked to severe inflammation of the liver caused by alcohol. When the liver suddenly stops working well, it's called 'hepatic decompensation'. This can lead to serious issues like yellow skin (jaundice), fluid build-up in the tummy (ascites), and brain problems (encephalopathy).

When you have ACLF, your body's defence system (immune system) can sometimes over-react, which makes things worse for your liver and other organs. This study is testing two new medicines. One, called TAK-242, aims to calm down this over-reaction. The other, G-CSF (also known as Filgrastim), is thought to help liver cells to repair and grow. Doctors want to see if using these two medicines together with current treatments can help people with ACLF get better and recover more effectively.

The main goals are to check if this new treatment combination is safe for patients and if it can reduce how severe the liver problems are. By calming the immune system and encouraging liver repair, the researchers hope to improve the chances of recovery for people with this very serious condition.

Key takeaways

The study tests new medicines (TAK-242 and G-CSF) for severe liver failure.
It aims to calm immune over-reaction and help liver cells grow.
You'll receive either standard care, TAK-242, or TAK-242 plus G-CSF.
Participation involves hospital treatment and follow-up visits over about 3 months.
The study is double-blind, meaning you won't know which treatment group you're in.

Who may be eligible?

This study is looking for men and women aged between 18 and 75 years old. To take part, you must have a diagnosis of severe alcoholic hepatitis that hasn't responded to steroid treatment, or you can't have steroids for other health reasons. You also need to have a specific level of ACLF (Grade 1-3) and meet certain scores related to your liver and overall health.

There are also reasons why you might not be able to join. For example, if you've recently had an organ transplant, or if you have certain other serious health issues like some types of cancer, or if you have specific infections that haven't been treated yet. You also can't join if you're pregnant or breastfeeding, or if you're allergic to eggs.

It's important to remember that these are just some of the main rules. Your study doctor will carefully check all your health details to see if this study is suitable and safe for you. You must also be willing to follow contraception guidelines if you are able to become pregnant or get someone else pregnant.

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.

Are you between 18 and 75 years old?
Have you been diagnosed with severe alcoholic hepatitis that hasn't responded to steroids or where steroids can't be used?
Do you have a specific grade of Acute-on-Chronic Liver Failure (ACLF)?
Are you able to use acceptable methods of contraception?
Have you *not* had an organ transplant in the past?
Do you *not* have certain other serious health conditions, such as some cancers or untreated infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be placed into one of three groups by chance, like flipping a coin. You won't know which group you're in, and neither will your doctors (this is called 'double-blind').

* **Group 1:** You'll receive the standard treatment for your liver condition, plus two 'placebos'. A placebo looks exactly like the study medicines but doesn't contain any active drug. This helps us know if any improvements are due to the study drugs or something else. * **Group 2:** You'll receive the standard treatment, plus TAK-242 given directly into your vein (intravenous drip) for 10 days. You'll also get a placebo instead of G-CSF. * **Group 3:** You'll receive the standard treatment, plus TAK-242 as an intravenous drip for 10 days, and daily injections of G-CSF under your skin for 5 days, plus one more on Day 8 (6 injections in total).

All treatments will be given while you are in hospital. After your treatment period, you'll have follow-up visits on day 14, day 28, and day 84. The whole study, including screening and follow-up, will last about 86 days for each patient.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You would receive close monitoring from medical staff and access to potentially new treatments that might improve your liver condition if they prove effective. However, there's no guarantee that you will personally benefit. Like all medicines, TAK-242 and G-CSF can have side effects, and some might be serious. Because these are new treatments, not all possible risks are fully known. Your health will be carefully watched throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Acute-on-Chronic Liver Failure (ACLF)?

It's a serious condition where someone with long-term liver disease suddenly gets much sicker, and their liver or other organs stop working properly.

What are TAK-242 and G-CSF?

TAK-242 is a new medicine designed to calm the body's over-reaction, and G-CSF is a medicine that might help liver cells to grow.

Why is a 'placebo' used in the study?

A placebo is a dummy treatment. It helps doctors work out if any changes in patients are really due to the new medicines or just other factors.

How long will I be involved in the study?

If you join, your involvement, including screening and follow-up visits, will last for about 86 days.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your usual medical care.

How to find out more

Monica Razdan

monica.razdan@klinera.com +917045561443 Official trial record

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