Study Stopped
Study was suspended until FDA approved the IND. Study has since been terminated and a new screening process has been implemented.
Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer
2 other identifiers
observational
1
1 country
1
Brief Summary
Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe inherited blistering skin disease caused by absence of type VII collagen. Patients with RDEB develop large, severly painful blisters and open wounds from minor trauma to their skin. In the future, we hope to start a gene transfer study on a specific group of RDEB subjects and we are screening subjects for that potential trial now.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedMay 27, 2015
May 1, 2015
1 year
September 20, 2007
May 22, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Disease documentation
Documentation of disease
1 year
documentation of disease
documentation of disease
1 year
Eligibility Criteria
Adults with RDEB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfred T Lane
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Dermatology and of Pediatricsy, Emeritus
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 21, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
May 27, 2015
Record last verified: 2015-05