Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with lumacaftor/ivacaftor (Orkambi™).

Key facts

Study ID

NCT02589236

Run by

Nivalis Therapeutics, Inc.

People needed

138

Starts

2015-11-01

Expected to finish

2016-12-01

Last updated by the study team

2017-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have been treated with lumacaftor/ivacaftor for at least 8 weeks prior to Day 1 (start of dosing)
• A history of Sweat Chloride (SC) ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) (either before or after starting lumacaftor/ivacaftor treatment)
• Body weight ≥ 40 kg
• ppFEV1 40 - 85 % predicted (inclusive) at screening
• Oxygen saturation ≥ 90% breathing ambient air at screening

You may not qualify if…

• Any acute infection that requires treatment or hospitalization within 2 weeks of Study Day 1
• Colonization with organisms associated with more rapid decline in pulmonary status, such as Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus
• Any change in the regimen for chronic therapies for CF lung disease (e.g., Pulmozyme®, hypertonic saline, Azithromycin, TOBI®, Cayston®) within 4 weeks of Study Day 1
• Are pregnant, planning a pregnancy, or breast-feeding at screening
• Blood hemoglobin < 10 g/dL at screening
• Serum albumin < 2.5 g/dL at screening
• Abnormal liver function defined as ≥ 3 x upper limit of normal (ULN)
• History of abnormal renal function within 3 months of screening
• History of ventricular tachycardia or other clinically significant ventricular arrhythmias
• History, including the screening assessment, of prolonged QT and/or QTcF (Fridericia's correction) interval
• History of solid organ or hematological transplantation
• History of alcohol abuse or drug abuse
• Ongoing participation in another therapeutic clinical trial
• Use of continuous (24 hr/day) or nocturnal supplemental oxygen

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Banner University of Arizona Medical Center — Tucson, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Luke's CF Center of Idaho — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Saint Francis Medical Center — Peoria, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Via Christi Research — Wichita, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Wayne State University-Harper — Detroit, Michigan, United States
• Spectrum Health Butterworth Hospital — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.