ICTUImperial Clinical Trials Unit

Welcome to Imperial Clinical Trials Unit (ICTU)

This website is intended for commercial trial sponsors engaged in the area of pharmaceuticals, medical devices or diagnostic devices

Clinical Trials Search


CurrentAll Trials

MDT gene therapy

Trial Details

  • Trial statusCompleted
  • Chief InvestigatorEric Alton
  • SponsorImperial College London
  • ISRCTN number71164341
  • Phase2B

Repeated application of gene therapy in CF patients

Design and Objective

Design: randomised, double-blind placebo-controlled study. Randomisation will be on a 1:1 basis, stratified for centre, age and FEV1. Objective: To assess clinical efficacy, safety & tolerability and gene expression of repeated doses of gene therapy.

Key inclusion criteria

1. Cystic fibrosis confirmed by sweat testing or genetic analysis 2. Males and females >=12 yrs 3. FEV1 between 50 & 90% predicted inclusive 4. Clinical stability at screening 5. Effective contraception 6. Written informed consent obtained 7. Permission to inform GP of participation in study

Study Disclaimer Statement