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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 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.

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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™).

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

FieldValue
Enrollment Target 138 participants
Start Date 2015-11
Est. Completion 2016-12
Phase Phase 2

Sponsor

Nivalis Therapeutics

10 total trials

What the Registry Record Tells You About NCT02589236

The ClinicalTrials.gov registry entry for NCT02589236 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (22% lower). The listed sponsor is Nivalis Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.