Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis
NCT ID: NCT00004428
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
1997-09-30
1999-10-31
Brief Summary
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II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.
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Detailed Description
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There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation.
All patients return for a follow up evaluation 1 week after dosing.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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CPX
Eligibility Criteria
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Inclusion Criteria
* Mild cystic fibrosis
* Not pregnant or nursing Negative pregnancy test
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
FDA Office of Orphan Products Development
FED
Principal Investigators
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Eduardo Martins
Role: STUDY_CHAIR
SciClone Pharmaceuticals
References
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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.
Other Identifiers
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SCICLONE-FDA-OP-97-1
Identifier Type: -
Identifier Source: secondary_id
199/13364
Identifier Type: -
Identifier Source: org_study_id
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