Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation

NCT02589236 · View on ClinicalTrials.gov ↗

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

3 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02589236

The ClinicalTrials.gov registry entry for NCT02589236 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nivalis Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02589236 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Colorado, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02589236?

The interventions under investigation include: Placebo (DRUG), Cavosonstat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02589236?

This trial is sponsored by Nivalis Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial