Trial · NCT02724527
Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor
NCT02724527, Phase 2, Unknown, Nivalis Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor. Trials, record NCT02724527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02724527
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor
- NCT number
- NCT02724527
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Conditions
- Cystic Fibrosis
- Interventions
- Cavosonstat, Placebo
- First posted
- 2016-03-31
- Last updated
- 2016-11-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The absolute change in ppFEV1 in the N91115 treated group | Baseline, week 4 and 8 assessments | Forced Expiratory Volume (FEV) absolute measurements comparing baseline to after 4 and 8 weeks of N91115 treatment. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) is calculated using the Hankinson method. |
| Secondary | The relative change from study baseline within the active treatment group in ppFEV1 values | Baseline, week 4 and 8 assessments | Forced Expiratory Volume relative measurements comparing baseline to after 4 and 8 weeks of N91115 treatment. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) is calculated using the Hankinson method. |
| Secondary | Absolute change from study baseline within the active treatment group in sweat chloride | Baseline, week 4 and 8 assessments | Sweat chloride concentration measured by pilocarpine iontophoresis, a standard clinical laboratory technique. Sweat collection accomplished with the Wescor Macroduct System. |
| Secondary | Changes in the respiratory domain of the Cystic Fibrosis Questionnaire - Revised, (CFQ-R) | Baseline, week 4 and 8 assessments | Patient questionnaires will compare baseline scores on their respiratory symptoms to weeks 4 and 8 |
| Secondary | Absolute change from baseline within the active treatment group in Patient Global Impression of Change | Baseline, week 4 and 8 assessments | Patient questionnaires will compare baseline global impression of changes in health from baseline to weeks 4 and 8 |
| Secondary | Safety as determined by adverse events assessment | Baseline to 8 weeks treatment with a 28-day follow up period | Assessments of clinical laboratory values, electrocardiogram (ECG), pulmonary exacerbations, and vital signs |
| Secondary | Pharmacokinetic Assessment of Maximum Plasma Concentration [Cmax] for N91115 & ivacaftor | Weeks 1, 4 and 8 | Plasma collection for assessment of N91115 and ivacaftor Cmax |
| Secondary | Pharmacokinetic Assessment of area under the plasma concentration verse time curve [AUC] for N91115 & ivacaftor | Weeks 1, 4 and 8 | Plasma collection for assessment of N91115 and ivacaftor AUC |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02724527
GET https://conductscience.org/api/trials/v1/NCT02724527/registered