NCT00004471

Brief Summary

OBJECTIVES: Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

5.8 years

First QC Date

October 18, 1999

Last Update Submit

March 28, 2011

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseasescystic fibrosisgenetic diseases and dysmorphic syndromesrare disease

Interventions

pGT-1 gene lipid complexGENETIC

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Cystic fibrosis patients * Not pregnant Fertile patients must use effective contraception

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic FibrosisRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric J. Sorscher

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

August 1, 1995

Primary Completion

May 1, 2001

Last Updated

March 29, 2011

Record last verified: 2011-03