BridgeMD
Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis.
EU CTIS ID: 2024-518102-41-00
What this study is testing
The evaluation of the activity of Thymosin alpha 1 in patients with cystic fibrosis (CF) by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, from 18 years of age (inclusive) at the time of screening.
- Blood pressure: DBP values between 60 and 89 mmHg, and SBP values between 90 and 139 mmHg. ECG normal or wave changes not considered clinically significant.
- Pulse betweem 50 and 120 bpm unless deemed clinically. insignificant by the PI.
- Signed Informed Consent.
- Confirmed diagnosis of CF, based on the following: two sweat chloride tests with a result = 60 mEq/L or two CFTR mutations on genetic test.
- CF diagnosis independently of genetic mutations.
You likely can't join if
- Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days prior to the screening).
- In the judgment of the PI, clinically significant hemoptysis (>30 ml per episode) within the last 180 days.
- History of allergy, hypersensitivity, intolerance to Thymosin alpha1 and to its excipients (Mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate)
- Ongoing or prior participation in an investigational drug study within 30 days of screening.
- Any malignancy or chronic organ failure or disease that depart from the patient's usual baseline level of health as a patient with CF.
- Patients with “F508del homozygous mutation” treated successfully with corrector potentiators, according to physicians’ judgment.
See the full eligibility criteria
- Male or female, from 18 years of age (inclusive) at the time of screening.
- Blood pressure: DBP values between 60 and 89 mmHg, and SBP values between 90 and 139 mmHg. ECG normal or wave changes not considered clinically significant.
- Pulse betweem 50 and 120 bpm unless deemed clinically. insignificant by the PI.
- Signed Informed Consent.
- Confirmed diagnosis of CF, based on the following: two sweat chloride tests with a result = 60 mEq/L or two CFTR mutations on genetic test.
- CF diagnosis independently of genetic mutations.
- Clinical stability with no change in symptoms and/or medication within 4 weeks prior to screening.
- Body mass index (BMI) = 15.0 (kg/m2).
- Non-tobacco/nicotine-containing product user for a minimum of 6 months prior to screening.
- Percent Predicted Forced Expiratory Volume (ppFEV1) > 40%, predicted at screening.
- Female with pregnancy test negative and using an acceptable contraception method, except if postmenopausal for more than 2 years or sterilized for more than 3 months.
- Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days prior to the screening).
- In the judgment of the PI, clinically significant hemoptysis (>30 ml per episode) within the last 180 days.
- History of allergy, hypersensitivity, intolerance to Thymosin alpha1 and to its excipients (Mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate)
- Ongoing or prior participation in an investigational drug study within 30 days of screening.
- Any malignancy or chronic organ failure or disease that depart from the patient's usual baseline level of health as a patient with CF.
- Patients with “F508del homozygous mutation” treated successfully with corrector potentiators, according to physicians’ judgment.
- Intravenous antibiotic use in the last 4 weeks before screening.
- Treatment with oxygen.
- History of organ or hematological transplantation.
- Kidney (creatinine 2-fold of the normal upper limit) or hepatic alterations (Child Pugh score equal to B or C).
- History or presence of alcoholism or drug abuse within 2 years prior to the screening.
- Personal or family history of prolonged QT syndrome; or a QTc interval >430 msec (males) or > 450 msec (females) using Bazett's formula (QTcB) or deemed clinically significant by the PI.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.