Clinical trials: Pancreatic Fibrosis
Cystic Fibrosis
Comparison of Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis
Non-invasive methods of the quantification of fibrosis may help to assess the development of fibrosis at a specific moment of the evolution of the disease, in the order to decide the initiation of treatment with ursodeoxycholic…
- Trial name
- MUCO-FIBRO (NCT02342964)
- Testing
- Measure of hepatic elasticity
- Where
- France
- Volunteers
- 56 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cystic Fibrosis
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF…
- Trial name
- NCT03525444
- Testing
- VX-445/TEZ/IVA, IVA
- Where
- 115 sites in United States, Australia and 11 more
- Volunteers
- 405 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis (CF), Pancreatic Insufficiency
Safety of Stopping Pancreatic Enzyme Replacement Therapy in Children With Improved Pancreatic Function After Highly Effective Modulator Therapy
The goal of this clinical trial is to evaluate the safety of stopping pancreatic enzyme replacement therapy (PERT) in children with cystic fibrosis (CF) receiving CFTR modulator therapy (CFTRm) who have regained pancreatic…
- Conditions
- Cystic Fibrosis (CF), Pancreatic Insufficiency, Pancreas Disease, Exocrine Pancreatic Insufficiency
- Trial name
- NCT07632768
- Testing
- Discontinuation of Pancreatic Enzyme Replacement Therapy
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indiana University
Cystic Fibrosis, Cystic Fibrosis Liver Disease
Utility of Point Shear-wave Elastography to Assess for Hepatic & Pancreatic Fibrosis in Pediatric CF Patients
Diagnosis of hepatic fibrosis is challenging as specific tests for detection of fibrosis in pediatric Cystic Fibrosis associated liver disease (CFALD) have not been developed and existing investigations do not correlate well with…
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Liver Disease, Pancreatic Insufficiency Due to Cystic Fibrosis of Pancreas
- Trial name
- CFALD (NCT03264950)
- Testing
- Elastography
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- University of Manitoba
Cystic Fibrosis
A Safety and Tolerability Study OF PUR118 In Subjects With Cystic Fibrosis
The purpose of this study is to determine whether PUR118 is safe and tolerable in a population of subjects with Cystic Fibrosis.
- Trial name
- NCT01543191
- Testing
- PUR118
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Pulmatrix Inc.
Cystic Fibrosis
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine…
- Trial name
- NCT03924947
- Testing
- Pancrelipase
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- AbbVie
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
- Trial name
- NCT02269189
- Testing
- BIIL 284 BS, high dose, BIIL 284 BS, low dose
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation
The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician…
- Trial name
- NCT04702360
- Testing
- ELX/TEZ/IVA, IVA
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.
- Trial name
- NCT02722122
- Testing
- AIR DNase™
- Where
- 5 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Protalix
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
Cystic Fibrosis
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
- Trial name
- REACH-1 (NCT01181622)
- Testing
- denufosol tetrasodium Inhalation Solution, 0.9% w/v sodium chloride solution
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis, CFTR Gene Dysfunction
CFTR Related Pancreatitis Study
The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis.
- Trial name
- NCT04274413
- Testing
- Beta Adrenergic Sweat Test
- Sponsor
- The Hospital for Sick Children
Cystic Fibrosis
A Study of Ataluren in Pediatric Participants With Cystic Fibrosis
In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00458341
- Testing
- Ataluren
- Where
- 3 sites in Belgium, France
- Volunteers
- 30 people
- Sponsor
- PTC Therapeutics
Cystic Fibrosis
Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis
This is an open-label, single center, prospective study of patients with a diagnosis of cystic fibrosis (CF) and a history of methicillin-resistant Staphylococcus aureus (MRSA), also known as oxacillin-resistant Staphylococcus…
- Trial name
- NCT03771313
- Testing
- Ceftaroline
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Cystic Fibrosis, Mucoviscidosis
Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.
- Trial name
- STIMUCO (NCT00391703)
- Testing
- Electrostimulation programme: using a cycloergometer, Usual sport activity
- Where
- 2 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Grenoble
Cystic Fibrosis
Costs of Care and Adherence to Treatment for Cystic Fibrosis
Evolution of medical care for patients with cystic fibrosis appeared in recent years: prolongation of life expectancy with consequently increased comorbidities and the use of lung transplantation, systematic neonatal screening of…
- Trial name
- COMURA MUCOBS (NCT02832479)
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Hospices Civils de Lyon
Cystic Fibrosis
Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients
Staphylococcus aureus is not only one of the first pathogens infecting the airways of cystic fibrosis (CF) patients, but also a highly prevalent microorganism (>60% of all CF patients; European and American CF registries; (4,25)…
- Trial name
- StaphCI (NCT00669760)
- Testing
- non-interventional study
- Where
- 17 sites in Austria, Germany
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- University Hospital Muenster
Cystic Fibrosis
Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients
The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients. The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the…
- Trial name
- SPutOM-CF (NCT04735679)
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Montpellier
Cystic Fibrosis
I Change Adherence & Raise Expectations
The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement.
- Trial name
- iCARE (NCT01232478)
- Testing
- Comprehensive Adherence Program (CAP)
- Where
- 18 sites in United States
- Volunteers
- 641 people
- Sponsor
- Johns Hopkins University
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
- Trial name
- NCT02465450
- Testing
- JBT-101 (lenabasum)
- Where
- 27 sites in United States, Belgium and 5 more
- Volunteers
- 85 people
- Sponsor
- Corbus Pharmaceuticals Inc.
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