Clinical trials: Pancreatic Exocrine Insufficiency
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Chronic Pancreatitis
Fat Malabsorption in Chronic Pancreatitis
The objective of this study is to evaluate the malabsorption blood test (MBT), stool coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential screening or diagnostic tests for reduced exocrine…
- Trial name
- NCT02849704
- Testing
- Creon36™
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis
Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI).
- Trial name
- SPAN (NCT05719311)
- Testing
- adrulipase
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Entero Therapeutics
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase.
- Trial name
- NCT02279498
- Testing
- Liprotamase, porcine (pig) PERT
- Where
- 54 sites in United States, Canada and 5 more
- Volunteers
- 128 people
- Sponsor
- Anthera Pharmaceuticals
Exocrine Pancreatic Insufficiency
Phase 1 Study to Assess Safety and Efficacy of ANG003
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency.
- Trial name
- NCT06052293
- Testing
- ANG003
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Anagram Therapeutics, Inc.
Exocrine Pancreatic Insufficiency, Pancreatic Diseases
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and…
- Conditions
- Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Trial name
- NCT01427725
- Testing
- Lipacreon
- Where
- 189 sites in Japan
- Volunteers
- 579 people
- Sponsor
- Mylan Inc.
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01529827
- Testing
- fludarabine phosphate, melphalan, total-body irradiation
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Roswell Park Cancer Institute
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
Thalassemia, Sickle Cell Disease
Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic blood and marrow transplantation remains the only viable cure for children who suffer from many serious non-malignant hematological diseases. Transplantation, however, carries a high risk of fatal complications.
- Conditions
- Thalassemia, Sickle Cell Disease, Glanzmann Thrombasthenia, Wiskott-Aldrich Syndrome
- Trial name
- NCT01319851
- Testing
- Alefacept
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University
Pancreatic Insufficiency, Pancreatic Cancer
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
- Conditions
- Pancreatic Insufficiency, Pancreatic Cancer, Pancreatic Enzyme Abnormality
- Trial name
- NCT02985801
- Testing
- Pancrelipase
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massimo Raimondo, M.D.
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT03333486
- Testing
- Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Roswell Park Cancer Institute
Sickle Cell Disease, Thalassemia
Stem Cell Transplant for Hemoglobinopathy
This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies.
- Conditions
- Sickle Cell Disease, Thalassemia, Severe Congenital Neutropenia, Diamond-Blackfan Anemia
- Trial name
- NCT00176852
- Testing
- Busulfan, Fludarabine, ATG, TLI, Busulfan, Cyclophosphamide, ATG, GCSF, Campath, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Exocrine Pancreatic Insufficiency (EPI)
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected…
- Trial name
- NCT03859869
- Testing
- Pancrelipase
- Where
- 33 sites in United States
- Volunteers
- 1 people
- Sponsor
- AbbVie
Cystic Fibrosis, Pancreatic Insufficiency
Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop.
- Trial name
- NCT01879228
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Pennsylvania
Pancreatic Insufficiency, Cystic Fibrosis
Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency.
- Trial name
- NCT03551691
- Testing
- Omeprazole 20mg Capsule
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Children's Hospital of Philadelphia
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to…
- Trial name
- NCT04375878
- Testing
- MS1819, Porcine PERT
- Where
- 15 sites in United States, Poland
- Volunteers
- 27 people
- Sponsor
- Entero Therapeutics
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP)…
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy
- Trial name
- NCT00559364
- Testing
- Viokase® 16, Proton pump inhibitor (PPI), Omeprazole
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Forest Laboratories
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.
Chronic Pancreatitis, Pancreatectomy
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy.
- Conditions
- Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
- Trial name
- NCT00414908
- Testing
- Pancrelipase delayed release capsule
- Where
- 30 sites in United States, Bulgaria and 6 more
- Volunteers
- 52 people
- Sponsor
- Solvay Pharmaceuticals