Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.

Key facts

Study ID

NCT02532764

Run by

ProQR Therapeutics

People needed

70

Starts

2015-06-01

Expected to finish

2017-09-14

Last updated by the study team

2019-02-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of CF as defined by iontophoretic pilocarpine sweat chloride test (sweat chloride) of > 60 mmol/L
• Confirmation of CFTR gene mutations homozygous for the ΔF508 mutation
• Body mass index (BMI) ≥ 17 kg/m2
• Non-smoking for a minimum of two years
• FEV1 ≥70% of predicted normal for age, gender, and height, at Screening
• Stable lung function
• Adequate hepatic and renal function

You may not qualify if…

• Breast-feeding or pregnant
• Use of lumacaftor or ivacaftor
• Use of any investigational drug or device
• History of lung transplantation
• Hemoptysis

Where it is running

• University of Southern California USC - Keck School of Medicine — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• University of Leuven — Leuven, Belgium
• University of Calgary (Health Sciences Centre) — Calgary, Alberta, Canada
• Motol University Hospital — Prague, Czechia
• Cystic Fibrosis Center Rigshospitalet — Copenhagen, Denmark
• HGRL Chu Nantes — Nantes, France
• Hopital Necker- Enfants Malades — Paris, France
• Charité Universitätsmedizin Berlin — Berlin, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Munich U. Hospital, Cystic Fibrosis Center for Adults — Munich, Germany
• Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Italy
• Hospital Vall D'Hebron — Barcelona, Spain
• Celerion — Belfast, Northern Ireland, United Kingdom

Full record on ClinicalTrials.gov

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