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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Hoffmann-La Roche

909 total trials

What the finished NCT02598193 record still lists

NCT02598193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (88% lower).

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 names 20 study sites across 17 states, led by 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.

Learn More About Clinical Trials

Similar trials for Idiopathic Pulmonary Fibrosis

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 NCT02598193's enrollment target sits among peer trials

89 22nd of 51 higher than 30 of 51 other Idiopathic Pulmonary Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Idiopathic Pulmonary 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02598193, the US trial registry maintained by the National Library of Medicine. NCT02598193 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.