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NCT01933334 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
A Phase 2 study of Systemic Sclerosis, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT01933334 is a Phase 2 study of Systemic Sclerosis that has completed, run by Genentech. The registered enrollment target is 63 participants, below the 277-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT01933334, a Phase 2 study of Systemic Sclerosis, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
Conditions Studied
Interventions
- DRUG Pirfenidone
Study Locations (20)
California
- University of California, Los Angeles - Los Angeles
- Stanford University School of Medicine - Redwood City
- University of California, San Francisco - San Francisco
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinic Foundation - Cleveland
- University of Toledo - Toledo
New York
- Hospital for Special Surgery - New York
- Columbia University - New York
Ontario
- St. Joseph's Healthcare - Hamilton
- Toronto General Hospital - Toronto
Arizona
- Mayo Clinic, Scottsdale - Scottsdale
Colorado
- National Jewish Medical and Research Center - Denver
District of Columbia
- Georgetown University Hospital - Washington D.C.
Illinois
- Northwestern University, Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01933334
The ClinicalTrials.gov registry entry for NCT01933334 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (77% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Pirfenidone is the first listed.
NCT01933334 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Ohio, New York.
Frequently Asked Questions
What is clinical trial NCT01933334 about?
NCT01933334 is a clinical study titled "Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)". PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
What is the current status of trial NCT01933334?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2013-10. Estimated completion is 2014-09.
What conditions does trial NCT01933334 study?
This clinical trial studies the following conditions: Systemic Sclerosis.
What interventions are being tested in trial NCT01933334?
The interventions under investigation include: Pirfenidone (DRUG).
Who is sponsoring clinical trial NCT01933334?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01933334 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.