drugset / Trial / NCT00004428
Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis
Phase 1
Completed
35 enrolled
FDA Office of Orphan Products Development
SciClone Pharmaceuticals · collab
RandomizedDouble-blindTreatment
Summary
OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis. II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.
Timeline
- Start
- 1997-09
- Primary completion
- —
- Completion
- 1999-10
Publications
- Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.
- Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPX | Unknown | — | Oral |