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NCT03000348 · ClinicalTrials.gov registry record · Phase 2
A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations
A Phase 2 study of Cystic Fibrosis, sponsored by NovaBiotics.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 17
- Study locations
NCT03000348: Completed Phase 2 study of Cystic Fibrosis, sponsored by NovaBiotics.
NCT03000348 is a Phase 2 study of Cystic Fibrosis that has completed, run by NovaBiotics. The registered enrollment target is 91 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (49% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03000348, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by NovaBiotics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.
Primary Outcome
Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load
Conditions Studied
Interventions
- DRUG Cysteamine
- DRUG Placebo Oral Capsule
Study Locations (17)
Other
- Ospedale Padiatrico Bambino Gesu Centro Fibrosi Cistica - Roma
- Azienda Ospedaliera Universitaria Integrato di Verona Borgo Trento Centro Fibrosi Cistica - Verona
- Ninewells Hospital Scottish Adult Cystic Fibrosis Service - Dundee
- Western General Hospital Edinburgh, CF Adults / CF Unit - Edinburgh
- NHS GGC - Glasgow
- Raigmore Hospital - Inverness
- St. James University Hospital - Leeds
- Royal Victoria Infirmary Adult CF Centre - Newcastle upon Tyne
Florida
- University of Florida - Gainesville
- Central Florida Pulmonary - Orlando
Arizona
- Banner University of Arizona Medical Center - Tucson
California
- San Francisco Critical Care Medical Group California Pacific Medical Center - San Francisco
New York
- Albany Medical College - Albany
Ohio
- Nationwide Children's Hospital - Columbus
West Virginia
- West Virginia University - Morgantown
Wisconsin
- The Medical College of Wisconsin/Froedtert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2016-12 |
| Est. Completion | 2018-04 |
| Phase | Phase 2 |
What the finished NCT03000348 record still lists
NCT03000348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Cysteamine is the first listed.
NCT03000348 lists 17 locations in 9 states (Other, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT03000348 about?
NCT03000348 is a clinical study titled "A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations". This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.
What is the current status of trial NCT03000348?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2016-12. Estimated completion is 2018-04.
What conditions does trial NCT03000348 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03000348?
The interventions under investigation include: Cysteamine (DRUG), Placebo Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03000348?
This trial is sponsored by NovaBiotics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03000348 being conducted?
This trial has 17 study locations across Arizona, California, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic 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 NCT03000348's enrollment target sits among peer trials
91 66th of 169 higher than 104 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic 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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