Clinical trials: Fibrosis
Cystic Fibrosis
Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)
The purpose of the study is to evaluate the natural history of exocrine pancreatic function by assessing Fecal elastase-1 (FE-1) in infants with CF during their first year of life.
- Trial name
- NCT06506773
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 79 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Renal Insufficiency
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not…
- Trial name
- NCT00773409
- Where
- United States
- Volunteers
- 405 people
- Sponsor
- Bracco Diagnostics, Inc
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after…
- Trial name
- NCT02172534
- Testing
- Tiotropium bromide low, Tiotropium bromide medium, Tiotropium bromide high
- Volunteers
- 113 people
- Sponsor
- Boehringer Ingelheim
Burns
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.
- Trial name
- NCT01067729
- Testing
- AWBAT Wound Dressing, AWBAT™, Biobrane®
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aubrey Inc.
Cystic Fibrosis
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for…
- Trial name
- NCT04105972
- Testing
- ELX/TEZ/IVA, TEZ/IVA, IVA
- Where
- 35 sites in Australia, Belgium and 2 more
- Volunteers
- 176 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation
- Trial name
- NCT02742519
- Testing
- ivacaftor
- Where
- 6 sites in Australia, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional…
- Trial name
- NCT04966897
- Testing
- Standard Nutritional Supplement + PERT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- GlycosBio, Inc.
Staphylococcus Aureus
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed…
- Trial name
- NCT00198289
- Testing
- Aurexis® (tefibazumab)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis
Extension Study of Ataluren (PTC124) in Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein.
- Trial name
- NCT01140451
- Testing
- Ataluren
- Where
- 31 sites in United States, Belgium and 9 more
- Volunteers
- 191 people
- Sponsor
- PTC Therapeutics
Long-term Safety of TIP
Ext. Long-term Safety Study in CF Patients: Single Arm TIP
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401.
- Trial name
- NCT01775137
- Testing
- TBM100
- Where
- 21 sites in United States, Argentina and 7 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del…
- Trial name
- NCT03525574
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 110 sites in United States, Australia and 11 more
- Volunteers
- 507 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the…
- Trial name
- NCT03447262
- Testing
- VX-659/TEZ/IVA, IVA
- Where
- 100 sites in United States, Australia and 9 more
- Volunteers
- 484 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years…
- Trial name
- NCT01863238
- Testing
- Ophthalmologic examinations, Ivacaftor Exposed
- Where
- 38 sites in United States
- Volunteers
- 95 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate…
- Trial name
- NCT00043342
- Testing
- interferon gamma-1b
- Volunteers
- 51 people
- Sponsor
- InterMune
Cystic Fibrosis
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for…
- Trial name
- NCT03559062
- Testing
- TEZ/IVA, IVA
- Where
- 27 sites in Australia, Belgium and 7 more
- Volunteers
- 67 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
Cystic Fibrosis
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis.
- Trial name
- NCT00446680
- Testing
- Mannitol
- Where
- 29 sites in Australia, Ireland and 1 more
- Volunteers
- 340 people
- Sponsor
- Syntara
Cystic Fibrosis
Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients
Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction…
- Trial name
- NCT00499837
- Testing
- Aerosolized, human, plasma-derived Alpha-1 Antitrypsin
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Kamada, Ltd.