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NCT01140451 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Ataluren (PTC124) in Cystic Fibrosis
A Phase 3 study, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 191
- Enrollment target
NCT01140451 is a Phase 3 study that has completed, run by PTC Therapeutics. The registered enrollment target is 191 participants.
The verdict
NCT01140451, a Phase 3 study, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 191 participants
- Enrollment target
Study Summary
Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.
Interventions
- DRUG Ataluren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2010-08-12 |
| Est. Completion | 2013-12-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01140451
The ClinicalTrials.gov registry entry for NCT01140451 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 191 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ataluren is the first listed.
NCT01140451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01140451 about?
NCT01140451 is a clinical study titled "Extension Study of Ataluren (PTC124) in Cystic Fibrosis". Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the di...
What is the current status of trial NCT01140451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 191 participants. The study started on 2010-08-12. Estimated completion is 2013-12-02.
What interventions are being tested in trial NCT01140451?
The interventions under investigation include: Ataluren (DRUG).
Who is sponsoring clinical trial NCT01140451?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
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