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	3

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	NCT01621867 (ClinicalTrials.gov)	May 2012	14/6/2012	Repeated Application of Gene Therapy in CF Patients	A Randomised, Double-blind, Placebo-controlled Phase 2B Clinical Trial of Repeated Application of Gene Therapy in Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: pGM169/GL67A;Drug: Placebo	Imperial College London	University of Edinburgh;University of Oxford;Royal Brompton & Harefield NHS Foundation Trust	Completed	12 Years	N/A	Both	130	Phase 2	United Kingdom
2	NCT00789867 (ClinicalTrials.gov)	November 2008	11/11/2008	Single Dose of pGM169/GL67A in CF Patients	Evaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic Fibrosis	Cystic Fibrosis	Drug: pGM169/GL67A	Imperial College London	Royal Brompton & Harefield NHS Foundation Trust;University of Oxford;University of Edinburgh;Cystic Fibrosis Trust;University of Pennsylvania	Completed	16 Years	70 Years	All	35	Phase 1;Phase 2	United Kingdom
3	EUCTR2007-004050-85-GB (EUCTR)	15/09/2008	13/10/2008	Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients	Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: pGM169/GL67A Product Code: pGM169/GL67A	Imperial College	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom

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

NCT01621867
(ClinicalTrials.gov)

May 2012

14/6/2012

Repeated Application of Gene Therapy in CF Patients

A Randomised, Double-blind, Placebo-controlled Phase 2B Clinical Trial of Repeated Application of Gene Therapy in Patients With Cystic Fibrosis

Cystic Fibrosis

Drug: pGM169/GL67A;Drug: Placebo

Imperial College London

University of Edinburgh;University of Oxford;Royal Brompton & Harefield NHS Foundation Trust

Completed

12 Years

N/A

Both

130

Phase 2

United Kingdom

NCT00789867
(ClinicalTrials.gov)

November 2008

11/11/2008

Single Dose of pGM169/GL67A in CF Patients

Evaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic Fibrosis

Cystic Fibrosis

Drug: pGM169/GL67A

Imperial College London

Royal Brompton & Harefield NHS Foundation Trust;University of Oxford;University of Edinburgh;Cystic Fibrosis Trust;University of Pennsylvania

Completed

16 Years

70 Years

All

Phase 1;Phase 2

United Kingdom

EUCTR2007-004050-85-GB
(EUCTR)

15/09/2008

13/10/2008

Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients

Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis

Product Name: pGM169/GL67A
Product Code: pGM169/GL67A

Imperial College

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom