Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis.
Key facts
- Where
- Parma, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Azienda Ospedaliero Universitaria ParmaParma, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sciclone Pharmaceuticals International (SG) Pte. Ltd.
- Trial code
- EU 2024-518102-41-00
- Record updated
- 2025. február 18.
- Original description
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.Read full original descriptionShow less
A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients
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.
Inclusion: 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.
Exclusion: Ongoing or prior participation in an investigational drug study within 30 days of screening; Intravenous antibiotic use in the last 4 weeks before screening; Treatment with oxygen; History or presence of alcoholism or drug abuse within 2 years prior to the 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; History of organ or hematological transplantation; Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days prior to the screening); History of allergy, hypersensitivity, intolerance to Thymosin alpha1 and to its excipients (Mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate); Kidney (creatinine 2-fold of the normal upper limit) or hepatic alterations (Child Pugh score equal to B or C); 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; In the judgment of the PI, clinically significant hemoptysis (>30 ml per episode) within the last 180 days; Patients with “F508del homozygous mutation” treated successfully with corrector potentiators, according to physicians’ judgment.