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NCT02589236 · ClinicalTrials.gov registry record · Phase 2
Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
A Phase 2 study of Cystic Fibrosis, sponsored by Nivalis Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT02589236: Completed Phase 2 study of Cystic Fibrosis, sponsored by Nivalis Therapeutics.
NCT02589236 is a Phase 2 study of Cystic Fibrosis that has completed, run by Nivalis Therapeutics. The registered enrollment target is 138 participants, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02589236, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Nivalis Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study Summary
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™).
Primary Outcome
Forced Expiratory Volume in one second (FEV1) from before study (Baseline) to after 12 weeks of N91115 treatment
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cavosonstat
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Stanford University - Palo Alto
- UC Davis Medical Center - Sacramento
Colorado
- Children's Hospital Colorado - Aurora
- National Jewish Health - Denver
Illinois
- Northwestern University - Chicago
- Saint Francis Medical Center - Peoria
Massachusetts
- Boston Children's Hospital - Boston
- University of Massachusetts Medical School - Worcester
Alabama
- University of Alabama - Birmingham
Arizona
- Banner University of Arizona Medical Center - Tucson
Connecticut
- Yale University - New Haven
Florida
- Tampa General Hospital - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT02589236 record still lists
NCT02589236 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02589236 names 20 study sites across 15 states, led by California, Colorado, Illinois.
Frequently Asked Questions
What is clinical trial NCT02589236 about?
NCT02589236 is a clinical study titled "Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation". 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 (Orkam...
What is the current status of trial NCT02589236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2015-11. Estimated completion is 2016-12.
What conditions does trial NCT02589236 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02589236?
The interventions under investigation include: Placebo (DRUG), Cavosonstat (DRUG).
Who is sponsoring clinical trial NCT02589236?
This trial is sponsored by Nivalis Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02589236 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02589236's enrollment target sits among peer trials
138 47th of 169 higher than 123 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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