Clinical trials: Cystic Fibrosis
Cystic Fibrosis
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in…
- Trial name
- NCT06154447
- Testing
- VX-828, Itraconazole, Midazolam
- Where
- 12 sites in United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the…
- Trial name
- NCT02412111
- Testing
- Ivacaftor, Tezacaftor/Ivacaftor
- Where
- 68 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6…
- Trial name
- NCT02953314
- Testing
- TEZ, TEZ/IVA, IVA
- Where
- 33 sites in United States, Canada
- Volunteers
- 83 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study of Sweat Testing Using a Quantitative Patch
The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing.
- Trial name
- NCT01345617
- Where
- 3 sites in United States
- Volunteers
- 170 people
- Sponsor
- Polychrome Medical, Inc.
Non-Cystic Fibrosis Bronchiectasis
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.
- Trial name
- NCT05344508
- Testing
- Brensocatib
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients
A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.
- Trial name
- NCT02532764
- Testing
- QR-010
- Where
- 27 sites in United States, Belgium and 8 more
- Volunteers
- 70 people
- Sponsor
- ProQR Therapeutics
Cystic Fibrosis
SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects
This is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P.
- Trial name
- NCT03669614
- Testing
- Inhaled AR-501
- Where
- 25 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Aridis Pharmaceuticals, Inc.
Cystic Fibrosis
A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)
The purpose of this study is to evaluate the safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or older.
- Trial name
- NCT05111145
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 24 sites in Australia, Belgium and 3 more
- Volunteers
- 86 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
The purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially…
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic Fibrosis
- Trial name
- NCT00744250
- Testing
- Pancrelipase
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Digestive Care, Inc.
Cytomegalovirus Infections
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis.
- Trial name
- NCT00377741
- Testing
- valganciclovir [Valcyte]
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients
The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.
- Trial name
- DPM-PK-102 (NCT00792714)
- Testing
- Mannitol
- Where
- 4 sites in Australia, United Kingdom
- Volunteers
- 18 people
- Sponsor
- Syntara
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes.
- Trial name
- NCT03051490
- Testing
- Liprotamase, porcine PERT
- Where
- 50 sites in United States, Hungary and 5 more
- Volunteers
- 140 people
- Sponsor
- Anthera Pharmaceuticals
Breast Cancer, Benign Breast Condition
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system.
- Conditions
- Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms
- Trial name
- AUDIBLE (NCT07505797)
- Testing
- ATUSA 3D Automated Breast Ultrasound System
- Where
- 2 sites in United States
- Volunteers
- 800 people
- Sponsor
- iSono Health, Inc.
Cystic Fibrosis
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa.
- Trial name
- NCT01316276
- Testing
- Liposomal amikacin for inhalation
- Where
- 50 sites in Austria, Belgium and 15 more
- Volunteers
- 206 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis, Cystic Fibrosis Gastrointestinal Disease
Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs
This is a Phase 2 study sponsored by AzurRx SAS and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF).
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Gastrointestinal Disease, Cystic Fibrosis of Pancreas
- Trial name
- NCT04302662
- Testing
- MS1819-SD
- Where
- 10 sites in Hungary, Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- AzurRx SAS
Cystic Fibrosis
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
- Trial name
- KONTINUE (NCT01707290)
- Testing
- Ivacaftor
- Where
- 38 sites in United States, Belgium and 2 more
- Volunteers
- 125 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare…
- Trial name
- CT03 Core (NCT00885365)
- Testing
- tobramycin / Bramitob, tobramycin / TOBI
- Where
- 44 sites in Czechia, France and 6 more
- Volunteers
- 324 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Cystic Fibrosis
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).
- Trial name
- NCT02976519
- Testing
- BI 443651
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pseudomonas Aeruginosa, Cystic Fibrosis
Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas…
- Trial name
- NCT00982930
- Testing
- Tobramycin inhalation powder
- Where
- 2 sites in Estonia, Russia
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals