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NCT04598919 · ClinicalTrials.gov registry record · Phase 1

Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis

A Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF), sponsored by National Jewish Health.

Active
Registry status
Phase 1
Development phase
49
Enrollment target
4
Study locations

NCT04598919 is a Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF) that is active but no longer recruiting, run by National Jewish Health. The registered enrollment target is 49 participants, below the 491-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT04598919, a Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF), is active but no longer recruiting, sponsored by National Jewish Health.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
49 participants
Enrollment target
4
Study locations

Study Summary

Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the prescribed drug within a year because of side effects. The study includes the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial. The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii) explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib in IPF patients

Interventions

  • DRUG Placebo
  • DRUG Saracatinab

Study Locations (4)

Colorado

  • National Jewish Health - Denver

Connecticut

  • Yale University School of Medicine - New Haven

New York

  • Icahn School of Medicine at Mount Sinai - New York

Texas

  • Baylor University Medical Center (BUMC) - Dallas

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2020-11-12
Est. Completion 2025-06-30
Phase Phase 1

Sponsor

National Jewish Health

83 total trials

What the Registry Record Tells You About NCT04598919

The ClinicalTrials.gov registry entry for NCT04598919 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 491-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (90% lower). The listed sponsor is National Jewish Health, which has 83 total studies on file at ClinicalTrials.gov.

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

NCT04598919 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Connecticut, New York.

Frequently Asked Questions

What is clinical trial NCT04598919 about?

NCT04598919 is a clinical study titled "Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis". Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the ...

What is the current status of trial NCT04598919?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2020-11-12. Estimated completion is 2025-06-30.

What conditions does trial NCT04598919 study?

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

What interventions are being tested in trial NCT04598919?

The interventions under investigation include: Placebo (DRUG), Saracatinab (DRUG).

Who is sponsoring clinical trial NCT04598919?

This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04598919 being conducted?

This trial has 4 study locations across Colorado, Connecticut, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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