Gastrointestinal Study at Orkambi Therapy in CF Patients
Launched by KAROLINSKA UNIVERSITY HOSPITAL · Feb 27, 2019
Trial Information
Current as of May 15, 2025
Unknown status
Keywords
ClinConnect Summary
To examine the entire intestinal mucosa via capsule endoscopy before and 6 months after Orkambi therapy to ascertain if the inflammatory changes in the intestine have improved. A marker of intestinal inflammation measured in the stool, Calprotectin, will be examined before and 6 months after Orkambi treatment. The investigators hypothesize that the result will be reduced on therapy.
A marker of pancreatic exocrine function, pancreatic elastase, will be examined before and 6 months after therapy to examine if the result has increased indicating improvement of exocrine pancreatic function
S...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • CF patients F508del homozygote
- • \>12 years of age
- • eligible for Orkambi therapy.
- Exclusion Criteria:
- • Patients who the patency capsule does not pass within 48 hrs
- • FEV1\<30%
- • Pregnancy and breastfeeding women
- • Liver function blood tests (AST, ALT, Gamma-GT, ALP) \>3 xULN
- • Bilirubin \>2 xULN
- • AST or ALT alone \>5 xULN
- • Previous lung transplant
About Karolinska University Hospital
Karolinska University Hospital is a leading academic medical center in Sweden, renowned for its commitment to advanced healthcare research and innovative clinical practices. As a key sponsor of clinical trials, the hospital leverages its extensive expertise in medical research and collaboration with Karolinska Institutet, one of the world's foremost medical universities. The institution is dedicated to enhancing patient care through rigorous scientific investigation, focusing on a wide range of therapeutic areas. With a multidisciplinary approach and a strong emphasis on translational medicine, Karolinska University Hospital aims to bridge the gap between laboratory findings and clinical application, ultimately striving to improve health outcomes and advance medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
Patients applied
Trial Officials
Isabelle de Monestrol, MD PhD
Principal Investigator
Stockholm CF Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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