Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00881556
Eligibility Criteria:
Inclusion Criteria:
* Recessive Dystrophic Epidermolysis Bullosa (RDEB)
* Diagnosis of RDEB using molecular diagnosis and sequencing of mutations
* Skin biopsy to determine status of type VII collagen
* Age ≤21 years
* Patient must have adequate organ function as below:
1. Adequate renal function defined as:
* Serum creatinine less than or equal to 1.5 x normal, or
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) =40 ml/min/m2 or \> 60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
2. Adequate liver function defined as:
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase (ALT))\< 5.0 x normal
3. Adequate cardiac function defined as:
* Shortening fraction of ≥28% by echocardiogram, or
* Ejection fraction of ≥48% by radionuclide angiogram or echocardiogram
4. Adequate pulmonary function defined as:
* Uncorrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥35% by pulmonary function test
* For children who are uncooperative, no evidence of dyspnea at rest
Exclusion Criteria:
* Karnofsky/Lansky Performance Score \<50%
* Pregnant or nursing
* Uncontrolled bacterial, viral or mold infection
* History or presence of skin squamous cell carcinoma
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00881556
Study Brief:
Protocol Section:
NCT00881556