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Single Dose of pGM169/GL67A in CF Patients

NCT00789867 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-01-18

Study results available
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Summary

The study objectives are to assess safety, tolerability and gene expression after a single dose of non-viral CFTR gene therapy (pGM169/GL67A) administered to the nose and lungs of patients with cystic fibrosis.

Conditions

Interventions

DRUG

pGM169/GL67A

Received a nebulized dose via an breath-actuated nebulizer

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • Cystic Fibrosis Trust

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Eric Alton · Imperial College London

  • Jane C Davies · Imperial College London

  • Uta Griesenbach · Imperial College London

  • Steve Hyde · University of Oxford

  • Deborah Gill · University of Oxford

  • David Porteous · Edinburgh University

  • Chris Boyd · Edinburgh University

  • Alastair Innes · Edinburgh University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-31
Completion
2010-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789867 on ClinicalTrials.gov