Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients

This study is investigating a drug called Thymosin alpha 1, also known as ZADAXIN®, to see how well it works and if it's safe for people with cystic fibrosis. Cystic fibrosis can cause a lot of inflammation, particularly in the lungs. Researchers want to find out if this treatment can help reduce this inflammation. They will measure specific markers of inflammation in lung fluid (sputum) to see if these levels change. The study will also carefully monitor any side effects and check various health signs like blood tests, physical exams, and heart readings to make sure the treatment is well-tolerated. Participants' lung function, quality of life, and other health markers will also be assessed to understand the drug's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sciclone Pharmaceuticals International (SG) Pte. Ltd.

Enrolment target

Start

04 Nov 2024

Cystic Fibrosis

What is this study about?

This study is exploring a new treatment option for people living with cystic fibrosis. Cystic fibrosis is a genetic condition that mainly affects the lungs, making them prone to infections and inflammation. This inflammation can cause damage over time and make breathing difficult.

The drug being tested is called Thymosin alpha 1, which you might also hear referred to by its brand name, ZADAXIN®. Researchers believe this drug might help by calming down the immune system and reducing the inflammation that is so common in cystic fibrosis. The main goal is to see if it can effectively lower the levels of inflammatory substances found in the lung fluid, which are key indicators of inflammation.

Beyond just looking at inflammation, the study will also carefully check for side effects to make sure the treatment is safe and well-tolerated by patients. They will also look at how it might affect other important aspects of health, such as lung function (how well a person can breathe), overall quality of life, and other health markers like sweat chloride levels. This will help doctors understand how beneficial this treatment could be for people with cystic fibrosis.

Key takeaways

This study is testing a new drug called ZADAXIN® (Thymosin alpha 1) for cystic fibrosis.
The main goal is to see if it can reduce inflammation in the lungs.
Researchers will also carefully check for side effects and how it affects overall health.
You must be an adult (18 or older) to take part, and both men and women are welcome.
Participation involves regular check-ups, tests, and taking the study medication.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or over. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to join the study.

The research team will have a more detailed list of specific health requirements. These might include certain details about your cystic fibrosis, other health conditions you might have, or medications you are currently taking. These checks are important to make sure the study is right for you and that the results will be clear.

Quick self-check

Are you 18 years old or older?
Are you able to provide sputum samples?
Are you a man or a woman?
Are you willing to attend regular study appointments and follow instructions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study medication, ZADAXIN®. The full details of how often you would take it and for how long would be explained by the study team. You would also have regular check-ups, which include physical examinations, blood tests, and heart tests (ECGs). Researchers will collect sputum samples to measure inflammation markers. Your lung function will be tested, and you'll fill out questionnaires about your quality of life. The study will carefully watch for any side effects throughout. The exact number of visits and the total length of your participation would be fully explained by the study team before you consent.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving a new treatment that might help reduce inflammation associated with your cystic fibrosis and potentially improve your health. However, as with any new medication, there's a chance of side effects, which could be mild or more serious – these will be carefully monitored. You'll be fully informed about all known risks before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is ZADAXIN®?

ZADAXIN® is the brand name for the drug Thymosin alpha 1, which this study is testing to see if it can help reduce inflammation in cystic fibrosis.

What is 'sputum' and why is it important?

Sputum is the mucus coughed up from your lungs. In this study, doctors will test it to measure substances related to inflammation in your airways.

Will this study cure my cystic fibrosis?

No, this study is not designed to cure cystic fibrosis. It aims to see if a new treatment can help manage some of the symptoms, specifically inflammation.

What does a 'Phase II' trial mean?

A Phase II trial means that researchers are trying to see if a treatment is effective and safe in a larger group of people after initial safety tests. It's a key step in developing new medicines.

Will I have to pay to be in the study?

No, you will not have to pay for the study medication or tests related to the research. These costs are covered by the study.