Clinical trials: Pancreatic Insufficiency
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
PR-018: An Open-Label, Safety Extension of Study PR-011
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to…
- Trial name
- NCT01131507
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 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.
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
Shwachman-Diamond Syndrome
Diabetes/ Endocrine Surveillance in SDS
Shwachman-Diamond syndrome(SDS) is a rare autosomal recessive disorder involving primarily the Shwachman-Bodian-Diamond syndrome gene located on chromosome 7q11.
- Trial name
- NCT04275479
- Testing
- Oral Glucose Tolerance Test, Modified Oral Glucose Tolerance Test, Modified Mixed Meal Tolerance Test
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Cystic Fibrosis, Liver Disease or Abnormalities
Diagnosis and Treatment of Patients With Cystic Fibrosis
This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural…
- Conditions
- Cystic Fibrosis, Liver Disease or Abnormalities, Diabetes, Pancreatic Insufficiency (Exocrine and Endocrine)
- Trial name
- NCT00001223
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cystic Fibrosis, Pancreatic Insufficiency
Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
The specific aims for this study are: 1. To determine if sonographic findings predict the risk of progression of liver disease to cirrhosis by comparing cystic fibrosis subjects with heterogeneous echogenicity pattern on…
- Trial name
- PUSH (NCT01144507)
- Testing
- Abdominal Ultrasound, Sample collection procedures
- Where
- 11 sites in United States, Canada
- Volunteers
- 774 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and…
- Trial name
- NCT00297167
- Testing
- EUR-1008 (APT-1008)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Forest Laboratories
Pancreatic Exocrine Insufficiency
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
- Trial name
- NCT01747330
- Testing
- Pancreatin
- Where
- 9 sites in Russia
- Volunteers
- 40 people
- Sponsor
- Abbott Products
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
EASY: Extended Access to Sollpura Over Years
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration…
- Trial name
- NCT02823964
- Testing
- Liprotamase
- Where
- 15 sites in United States, Czechia and 4 more
- Volunteers
- 25 people
- Sponsor
- Anthera Pharmaceuticals
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
Sickle Cell Disease, Chronic Kidney Diseases
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions
The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood…
- Conditions
- Sickle Cell Disease, Chronic Kidney Diseases, Systemic Lupus Erythematosus, Childhood Cancer
- Trial name
- PiCASO (NCT03938324)
- Testing
- PiCASO Intervention Group
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Duke University