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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02589236
Date of registration: 26/10/2015
Prospective Registration: Yes
Primary sponsor: Nivalis Therapeutics, Inc.
Public title: Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation SNO-6
Scientific title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/Ivacaftor
Date of first enrolment: November 2015
Target sample size: 138
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02589236
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Scott Donaldson, MD
Address: 
Telephone:
Email:
Affiliation:  University of North Carolina, Chapel Hill
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: Cavosonstat
Drug: Placebo
Primary Outcome(s)
Absolute change from baseline in percent predicted FEV1 (ppFEV1) [Time Frame: From baseline to 12 weeks]
Secondary Outcome(s)
Absolute change from baseline in Patient Global Impression of Change (PGIC) [Time Frame: baseline to 12 weeks]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) [Time Frame: baseline to 16 weeks]
Absolute change from baseline in body mass index (BMI) [Time Frame: baseline to 12 weeks]
Absolute change from baseline in Cystic Fibrosis Questionnaire -Revised CFQ-R (respiratory symptom scale) [Time Frame: baseline to 16 weeks]
Absolute change from baseline in sweat chloride [Time Frame: baseline to 12 weeks]
Pharmacokinetic Measurements of Area Under the Curve (AUC) for N91115, Ivacaftor and lumacaftor [Time Frame: baseline to 12 weeks]
Pharmacokinetic Measurements of Maximum Plasma Concentration [Cmax], of N91115, lumacaftor, and ivacaftor [Time Frame: baseline to 12 weeks]
Relative change from baseline in ppFEV1 [Time Frame: baseline to 12 weeks]
Secondary ID(s)
N91115-2CF-05
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Medidata Solutions
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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