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NCT00865904 · ClinicalTrials.gov registry record · Phase 2

Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation

A Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 2
Development phase
93
Enrollment target
20
Study locations

NCT00865904 is a Phase 2 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 93 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00865904, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 2
Development phase
93 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Conditions Studied

Cystic Fibrosis

Interventions

  • DRUG Placebo
  • DRUG VX-809

Study Locations (20)

Ohio

  • - Cincinnati
  • - Cleveland
  • - Columbus

California

  • - Palo Alto
  • - San Diego

Pennsylvania

  • - Philadelphia
  • - Pittsburgh

Other

  • - Brussels
  • - Leuven

Alabama

  • - Birmingham

Colorado

  • - Aurora

Georgia

  • - Atlanta

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2009-03
Est. Completion 2009-12
Phase Phase 2

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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What the Registry Record Tells You About NCT00865904

The ClinicalTrials.gov registry entry for NCT00865904 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (48% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 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.

NCT00865904 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Ohio, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00865904 about?

NCT00865904 is a clinical study titled "Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation". The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

What is the current status of trial NCT00865904?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2009-03. Estimated completion is 2009-12.

What conditions does trial NCT00865904 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT00865904?

The interventions under investigation include: Placebo (DRUG), VX-809 (DRUG).

Who is sponsoring clinical trial NCT00865904?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00865904 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Georgia, Illinois. 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 Editorial

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.