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Gastrointestinal Study at Orkambi Therapy in CF Patients

NCT03859531 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-03-04

No results posted yet for this study

Summary

Ivacaftor caused a significance increase in weight in patients carrying the G551D mutation and the etiology of this has largely remained unknown but may be due to improved function of the gastrointestinal tract. The combination therapy of Orkambi has been recently approved for subjects with Cystic Fibrosis homozygous for F508del mutation. This provides an opportunity to examine if there are any improvements in gastrointestinal function. The investigators aim to investigate various aspects of gastrointestinal and pancreatic function before and 6 months after the commencement of Orkambi therapy.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Isabelle de Monestrol, MD PhD · Stockholm CF Center

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03859531 on ClinicalTrials.gov