Trial · NCT02589236
Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
NCT02589236, Phase 2, Completed, Nivalis Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation. Trials, record NCT02589236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02589236
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
- NCT number
- NCT02589236
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 138 participants, actual
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Conditions
- Cystic Fibrosis
- Interventions
- Cavosonstat, Placebo
- First posted
- 2015-10-28
- Last updated
- 2017-01-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute change from baseline in percent predicted FEV1 (ppFEV1) | From baseline to 12 weeks | Forced Expiratory Volume in one second (FEV1) from before study (Baseline) to after 12 weeks of N91115 treatment |
| Secondary | Relative change from baseline in ppFEV1 | baseline to 12 weeks | Forced Expiratory Volume in one second (FEV1) from before study (Baseline) to after 12 weeks of N91115 treatment |
| Secondary | Absolute change from baseline in sweat chloride | baseline to 12 weeks | A sweat chloride measurement on the skin at study start and after 12 weeks of N91115 |
| Secondary | Absolute change from baseline in Cystic Fibrosis Questionnaire -Revised CFQ-R (respiratory symptom scale) | baseline to 16 weeks | Comparison of the Questionnaire from study start to 16 weeks |
| Secondary | Absolute change from baseline in body mass index (BMI) | baseline to 12 weeks | Assessment of change in body mass index from study start to after 12 weeks of N91115 |
| Secondary | Absolute change from baseline in Patient Global Impression of Change (PGIC) | baseline to 12 weeks | Patient reported outcome journal |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) | baseline to 16 weeks | Any adverse events assessment including clinical laboratory values, electrocardiogram (ECG), pulmonary exacerbations, or vital sign changes |
| Secondary | Pharmacokinetic Measurements of Maximum Plasma Concentration [Cmax], of N91115, lumacaftor, and ivacaftor | baseline to 12 weeks | Maximum Plasma Concentration \[Cmax\] measurements of N91115, lumacaftor and ivacaftor |
| Secondary | Pharmacokinetic Measurements of Area Under the Curve (AUC) for N91115, Ivacaftor and lumacaftor | baseline to 12 weeks | AUC measurements of N91115, lumacaftor and ivacaftor |
| Other | Number of pulmonary exacerbations | baseline to 12 weeks | Assessment of number of pulmonary exacerbations at baseline compared through 12 weeks |
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/NCT02589236
GET https://conductscience.org/api/trials/v1/NCT02589236/registered