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ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor

NCT02807415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2020-07-30

No results posted yet for this study

Summary

The academic investigator - initiated trial will evaluate in a postapproval setting whether, and if yes, to what extent and variability, the treatment with lumacaftor in combination with ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del homozygous subjects with cystic fibrosis under real life conditions.

Conditions

Interventions

DRUG

Lumacaftor plus Ivacaftor

Oral treatment with lumacaftor/ivacaftor tablets according to the prescribing information

Sponsors & Collaborators

  • Heidelberg University

    collaborator OTHER

  • University of Giessen

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Burkhard Tümmler, MD PhD · Hannover Medical School

  • Marcus Mall, MD · Heidelberg University

  • Lutz Nährlich, MD · University of Giessen

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2019-12-31
Completion
2020-02-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02807415 on ClinicalTrials.gov