NCT02807415 (OrkambiFacts) is a clinical trial of Lumacaftor plus Ivacaftor in Cystic Fibrosis, sponsored by Hannover Medical School.

Who is sponsoring NCT02807415?

NCT02807415 is sponsored by Hannover Medical School.

What drugs are being tested in NCT02807415?

Interventions in NCT02807415: Lumacaftor plus Ivacaftor.

What condition does NCT02807415 study?

NCT02807415 studies Cystic Fibrosis.

Is NCT02807415 still recruiting?

NCT02807415 is currently completed. Last updated 30 July 2020.

Last reviewed 2020-07-30 · How we verify

NCT02807415: OrkambiFacts

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 30 July 2020

What this trial tests

trial testing Lumacaftor plus Ivacaftor in Cystic Fibrosis in 104 participants. Completed in 10 February 2020.

Timeline

1 June 2016

Primary endpoint
31 December 2019

10 February 2020

Quick facts

Lead sponsor	Hannover Medical School
Status	Completed
Study type	OBSERVATIONAL
Enrollment	104
Start date	1 June 2016
Primary completion	31 December 2019
Estimated completion	10 February 2020
Sites	3 locations across Germany

Drugs / interventions tested

Lumacaftor plus Ivacaftor — full drug profile →

Conditions studied

Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Hannover Medical School

Who can join

6 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

CFTR Modulators: The Changing Face of Cystic Fibrosis in the Era of Precision Medicine.
Lopes-Pacheco M. · · 2019 · cited 349× · PMID 32153386 · DOI 10.3389/fphar.2019.01662
Effects of Lumacaftor-Ivacaftor Therapy on Cystic Fibrosis Transmembrane Conductance Regulator Function in Phe508del Homozygous Patients with Cystic Fibrosis.
Graeber SY, Dopfer C, Naehrlich L, Gyulumyan L, et al · · 2018 · cited 89× · PMID 29327948 · DOI 10.1164/rccm.201710-1983oc
Effects of Lumacaftor-Ivacaftor on Lung Clearance Index, Magnetic Resonance Imaging, and Airway Microbiome in Phe508del Homozygous Patients with Cystic Fibrosis.
Graeber SY, Boutin S, Wielpütz MO, Joachim C, et al · · 2021 · cited 80× · PMID 33600745 · DOI 10.1513/annalsats.202008-1054oc
Association of CFTR activity in sweat test, NPD, and ICM with ivacaftor and lumacaftor serum levels in Phe508del homozygous patients with cystic fibrosis
Dopfer C, Trittler R, Graeber SY, Casado JM, et al · · 2022 · DOI 10.22541/au.166171143.33189125/v1

Verify or expand the search:

Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting

Other Hannover Medical School trials

Trials by the same sponsor.

NCT07384039 — Exercise Training in Patients With Myeloproliferative Neoplasms · NA · not yet recruiting
NCT06740747 — Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia · NA · recruiting
NCT06795516 — Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation · terminated
NCT06603311 — Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of · NA · active not recruiting
NCT06493006 — Promoting Sustainable and Active Mobility Among Employees and Students · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02807415 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hannover Medical School
Last refreshed: 30 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02807415.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing