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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01784419
Date of registration:	03/02/2013
Prospective Registration:	Yes
Primary sponsor:	University of California, San Francisco
Public title:	Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients
Scientific title:	Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients
Date of first enrolment:	October 2013
Target sample size:	10
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01784419
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Screening. Masking: Triple (Participant, Care Provider, Investigator).
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Dennis W Nielson, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University of California, San Francisco

Key inclusion & exclusion criteria

Inclusion Criteria:

- Two mutations known to cause cystic fibrosis and a sweat chloride concentration
greater than or equal to 55 mmol

- Greater than or equal to 6 years of age

Exclusion Criteria:

- Homozygous F508del with a sweat chloride greater than 85 mmol

- Taking medication known to interact with ivacaftor and chooses not to discontinue that
medication

- Is pregnant or planning to become pregnant during the study period

- Less than 6 years of age

Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: ivacaftor

Drug: Placebo

Primary Outcome(s)

Sweat Chloride Concentration [Time Frame: 14 +/- 2 days]

Secondary Outcome(s)

Spirometry [Time Frame: 14 +/- 2 days]

Multibreath Washout Testing [Time Frame: 14 +/- 2 days]

Secondary ID(s)

FS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	29/09/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01784419

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