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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: Completed Phase 2 study of Systemic Sclerosis, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
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 |
What the finished NCT01933334 record still lists
NCT01933334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 277-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (77% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis
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 NCT01933334's enrollment target sits among peer trials
63 11th of 26 higher than 16 of 26 other Systemic Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis 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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