Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis.

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-001441-40-IT
• Lead Sponsor: SciClone Pharmaceuticals Limited Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Male or female, from 18 years of age (inclusive) at the time of screening.
•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.
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

•Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days 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.
•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.
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified