|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01538862 |
|
Date of registration:
|
20/02/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa
|
|
Scientific title:
|
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa |
|
Date of first enrolment:
|
February 2012 |
|
Target sample size:
|
7 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01538862 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Haydar Frangoul, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Vanderbilt University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Each patient must have the diagnosis of severe generalized recessive dystrophic EB
(formerly known as Hallopeau-Siemens RDEB) confirmed by clinical criteria and either
of the following:
1. transmission electron microscopy
2. immunofluorescence antigenic mapping and type VII collagen monoclonal antibody
staining
3. COL7A1 mutational analysis
Exclusion Criteria:
- The patient must not have a history of squamous cell carcinoma or any internal
malignancy.
- Female patients who are pregnant.
- Patients with active signs and symptoms of infection.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Dystrophic Epidermolysis Bullosa
|
|
Intervention(s)
|
|
Drug: Granulocyte Colony Stimulating Factor (GCSF)
|
|
Primary Outcome(s)
|
|
Percent Change of Active Blisters and in Total Blister/Erosion Counts
[Time Frame: 7 days]
|
|
Secondary Outcome(s)
|
|
Overall Improved Symptomatology
[Time Frame: 28 days]
|
|
Surface Area of Nonhealing Erosions
[Time Frame: 7 days]
|
|
Secondary ID(s)
|
|
VICCNCPED1210
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|