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NCT02648048 · ClinicalTrials.gov registry record · Phase 1

A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

A Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
15
Study locations

NCT02648048: Completed Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Hoffmann-La Roche.

NCT02648048 is a Phase 1 study of Idiopathic Pulmonary Fibrosis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 21 participants, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02648048, a Phase 1 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
15
Study locations

Study Summary

This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.

Primary Outcome

An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. A serious adverse event is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Interventions

  • DRUG Vismodegib
  • DRUG Pirfenidone

Study Locations (15)

North Carolina

  • Pulmonix LLC - Greensboro
  • PMG Research of Wilmington - Wilmington

Washington

  • Western Washington Medical Group - Everett
  • Swedish Medical Center - Seattle

California

  • Scripps Clinic - La Jolla

Florida

  • Central Florida Pulmonary Group, PA - Orlando

Illinois

  • Suburban Lung Associates - Elk Grove

Indiana

  • Medical Consultants, PC ; Pulmonary - Muncie

Kentucky

  • University of Louisville - Louisville

Louisiana

  • Tulane University Medical School - New Orleans

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2016-01-15
Est. Completion 2016-11-30
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT02648048 record still lists

NCT02648048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (97% lower).

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

NCT02648048 lists 15 locations in 13 states (North Carolina, Washington, California).

Frequently Asked Questions

What is clinical trial NCT02648048 about?

NCT02648048 is a clinical study titled "A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis". This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.

What is the current status of trial NCT02648048?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2016-01-15. Estimated completion is 2016-11-30.

What conditions does trial NCT02648048 study?

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

What interventions are being tested in trial NCT02648048?

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

Who is sponsoring clinical trial NCT02648048?

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

Where is trial NCT02648048 being conducted?

This trial has 15 study locations across California, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT02648048's enrollment target sits among peer trials

21 43rd of 51 higher than 9 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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Source: ClinicalTrials.gov NCT02648048, the US trial registry maintained by the National Library of Medicine. NCT02648048 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.