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NCT02598193 · ClinicalTrials.gov registry record · Phase 4

Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 4 study of Idiopathic Pulmonary Fibrosis, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
89
Enrollment target
20
Study locations

NCT02598193 is a Phase 4 study of Idiopathic Pulmonary Fibrosis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 89 participants, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT02598193, a Phase 4 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
89 participants
Enrollment target
20
Study locations

Study Summary

This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.

Conditions Studied

Idiopathic Pulmonary Fibrosis

Interventions

  • DRUG Pirfenidone
  • DRUG Nintedanib

Study Locations (20)

California

  • David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic - Los Angeles
  • Stanford University School of Medicine ; Pulmonary/Critical Care Medicine - Stanford

New York

  • Mount Sinai School of Medicine - New York
  • Columbia University Medical Center - New York

Other

  • Gentofte Hospital, Lungemedicinsk Afdeling - Hellerup
  • Hopital Avicenne; Pneumologie - Bobigny

Florida

  • Sarasota Memorial Hospital - Sarasota

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Michigan

  • University of Michigan Health System - Ann Arbor

Missouri

  • Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield

Nebraska

  • Creighton University - Omaha

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2016-01-14
Est. Completion 2017-05-16
Phase Phase 4

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02598193

The ClinicalTrials.gov registry entry for NCT02598193 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (88% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Pirfenidone is the first listed.

NCT02598193 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, New York, Other.

Frequently Asked Questions

What is clinical trial NCT02598193 about?

NCT02598193 is a clinical study titled "Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)". This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination ...

What is the current status of trial NCT02598193?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 89 participants. The study started on 2016-01-14. Estimated completion is 2017-05-16.

What conditions does trial NCT02598193 study?

This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.

What interventions are being tested in trial NCT02598193?

The interventions under investigation include: Pirfenidone (DRUG), Nintedanib (DRUG).

Who is sponsoring clinical trial NCT02598193?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02598193 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, Michigan, Missouri. 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.