Study on Thymalfasin for Adults with Cystic Fibrosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Thymosin alpha 1 in patients with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder that affects the lungs and other organs, leading to severe respiratory and digestive problems. The medication being tested, Thymosin alpha 1, is administered as a solution for injection under the skin. It is known to be a type of protein that can help modulate the immune system.

The purpose of this study is to evaluate how Thymosin alpha 1 affects certain inflammatory substances in the body, which are often elevated in people with Cystic Fibrosis. These substances, known as cytokines, include IL-1ß, IL-8, IL-17A, IL-6, and TNF-alpha. The study will monitor changes in these cytokines to understand the medication’s activity. Participants will receive the medication over a period of time, and their health will be closely monitored through various tests and assessments to ensure safety and tolerability.

Throughout the study, researchers will also evaluate the medication’s impact on lung function and quality of life. This will involve checking changes in lung capacity and using a questionnaire designed for people with Cystic Fibrosis. The study aims to provide valuable insights into the potential benefits of Thymosin alpha 1 for managing Cystic Fibrosis symptoms and improving patients’ overall well-being.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests.

Eligibility criteria include being 18 years or older, having a confirmed diagnosis of cystic fibrosis, and meeting specific health parameters such as blood pressure and body mass index.

2 baseline measurements

Baseline measurements are taken to establish a starting point for the study. These include tests for inflammatory markers in sputum, blood tests, and lung function tests.

A questionnaire is completed to assess quality of life related to cystic fibrosis.

3 medication administration

The medication ZADAXIN® (Thymosin alpha 1) is administered as a subcutaneous injection. The dosage is 1.6 mg/ml.

The frequency and duration of administration are determined by the study protocol and are explained during the initial assessment.

4 regular monitoring

Regular monitoring is conducted throughout the study to evaluate the activity and tolerability of the medication.

This includes physical examinations, vital signs checks, ECGs, and laboratory tests to monitor inflammatory markers and other health indicators.

5 follow-up assessments

Follow-up assessments are performed at specified intervals to track changes in health status and medication effects.

These assessments include repeated tests for inflammatory markers, lung function tests, and quality of life questionnaires.

6 final evaluation

At the end of the study, a final evaluation is conducted to assess the overall impact of the medication on cystic fibrosis symptoms and quality of life.

The results of this evaluation contribute to the study’s findings on the efficacy and safety of Thymosin alpha 1.

Who Can Join the Study?

Must be a male or female who is 18 years or older at the time of screening.
Blood pressure should be within these ranges: diastolic (lower number) between 60 and 89 mmHg, and systolic (upper number) between 90 and 139 mmHg. The heart’s electrical activity (ECG) should be normal or have changes that are not considered important for health.
Heart rate (pulse) should be between 50 and 120 beats per minute, unless the study doctor thinks it’s not important for health.
Must have signed a form agreeing to participate in the study, known as an Informed Consent.
Must have a confirmed diagnosis of Cystic Fibrosis (CF), which can be shown by two sweat tests with a result of 60 mEq/L or higher, or by having two CFTR gene mutations in a genetic test.
CF diagnosis is valid regardless of the specific genetic mutations.
Must be clinically stable, meaning no changes in symptoms or medication for at least 4 weeks before screening.
Body mass index (BMI) should be 15.0 or higher. BMI is a measure of body fat based on height and weight.
Must not have used tobacco or nicotine products for at least 6 months before screening.
Percent Predicted Forced Expiratory Volume (ppFEV1) should be more than 40% at screening. This is a measure of lung function.
If female, must have a negative pregnancy test and use an acceptable method of birth control, unless she has been postmenopausal for more than 2 years or has been sterilized for more than 3 months.

Who Cannot Join the Study?

Patients who do not have cystic fibrosis cannot participate. Cystic fibrosis is a genetic condition that affects the lungs and digestive system.
Patients who are not within the specified age range cannot participate. The age range for this study is from 4 to 18 years old.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their interests.

Where you can join this trial?

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Site Name	City	Country	Status
Axmzdcl Oiqvvtesizu Unydbdjbmqmgl Pcryb	Parma	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	14.12.2021

Trial locations

Investigated drugs:

Thymalfasin

Thymosin alpha 1 is a medication being studied for its potential benefits in patients with cystic fibrosis. It is being evaluated for its ability to influence the levels of certain inflammatory substances in the body, which are often elevated in cystic fibrosis. The goal is to see if this medication can help reduce inflammation and improve the health of patients with this condition.

Investigated diseases:

Cystic fibrosis

Cystic Fibrosis – Cystic fibrosis is a genetic disorder that affects the respiratory and digestive systems. It is caused by mutations in the CFTR gene, leading to the production of thick and sticky mucus. This mucus can clog the airways, causing breathing difficulties and frequent lung infections. Over time, the buildup of mucus can also affect the pancreas, hindering the digestion and absorption of nutrients. The disease progresses with persistent coughing, wheezing, and lung damage. It often requires ongoing management to address respiratory and digestive symptoms.

Trial ID:

2024-518102-41-00

Protocol code:

SC-Ta1-CF-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Thymalfasin for Adults with Cystic Fibrosis

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