DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
299	嚢胞性線維症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00457821 (ClinicalTrials.gov)	May 2007	5/4/2007	Safety Study of Ivacaftor in Subjects With Cystic Fibrosis	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D	Cystic Fibrosis	Drug: Ivacaftor 25 mg/75 mg;Drug: Ivacaftor 75 mg/150 mg;Drug: Ivacaftor 150 mg or 250 mg;Drug: Placebo	Vertex Pharmaceuticals Incorporated	Cystic Fibrosis Foundation Therapeutics	Completed	18 Years	N/A	All	39	Phase 2	United States;Canada;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00457821
(ClinicalTrials.gov)

May 2007

5/4/2007

Safety Study of Ivacaftor in Subjects With Cystic Fibrosis

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D

Cystic Fibrosis

Drug: Ivacaftor 25 mg/75 mg;Drug: Ivacaftor 75 mg/150 mg;Drug: Ivacaftor 150 mg or 250 mg;Drug: Placebo

Vertex Pharmaceuticals Incorporated

Cystic Fibrosis Foundation Therapeutics

Completed

18 Years

N/A

All

Phase 2

United States;Canada;Germany