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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00789867 |
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Date of registration:
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11/11/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Dose of pGM169/GL67A in CF Patients
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Scientific title:
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Evaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic Fibrosis |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00789867 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Chris Boyd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Edinburgh University |
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Name:
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Eric Alton |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Name:
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David Porteous |
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Address:
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Telephone:
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Email:
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Affiliation:
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Edinburgh University |
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Name:
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Uta Griesenbach |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Name:
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Alastair Innes |
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Address:
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Telephone:
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Email:
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Affiliation:
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Edinburgh University |
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Name:
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Jane C Davies |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Name:
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Deborah Gill |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Oxford |
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Name:
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Steve Hyde |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Oxford |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cystic fibrosis confirmed by sweat testing or genetic analysis
- Males and females aged 16 years and above
- Forced expiratory volume in the 1st second (FEV1) > 60% predicted values
- Clinical stability at entry
- Prepared to take effective contraceptive precautions for the duration of their
participation in the study and for 3 months thereafter
- If taking regular rhDNase (pulmozyme) is willing, and considered able by independent
medical carers, to withhold treatment for 24 hours before and 24 hours after the gene
therapy dose
- Written informed consent obtained
- Permission to inform GP of participation in study
Exclusion Criteria:
- Infection with Burkholderia cepacia complex organisms or MRSA
- Significant nasal pathology including polyps, clinically-significant rhinosinusitis,
or recurrent severe epistaxis (nose bleeds)
- Acute upper respiratory tract infection within the last 2 weeks
- Previous spontaneous pneumothorax without pleurodesis
- Recurrent severe haemoptysis
- Current smoker
- Significant comorbidity including:
1. Moderate/severe CF liver disease
2. Significant renal impairment
3. Significant coagulopathy
- Receiving 2nd line immunosuppressant drugs such as methotrexate, cyclosporine,
intravenous immunoglobulin preparations
- Pregnant or breastfeeding
Age minimum:
16 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: pGM169/GL67A
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Primary Outcome(s)
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Blood Leukocytes
[Time Frame: 8h]
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Blood Neutrophils
[Time Frame: 8h]
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FVC Relative % Drop
[Time Frame: 6h]
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Body Maximum Temperature
[Time Frame: 6-8h]
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FEV1 Relative % Drop
[Time Frame: 8h]
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Lung Clearance Index - LCI
[Time Frame: 8h]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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