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 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT00494195
Eligibility Criteria:
Inclusion Criteria:
* Six LGMD2D subjects ages 5 and older based on the clinical degree of involvement (impaired muscle function/weakness, sufficient muscle preservation)
* Preservation of EDB muscle or another muscle if judged more favorable because of adequate muscle mass for gene transfer
* Males and females of any ethnic group
* Established mutations of an -SG gene on both alleles
* Ability to cooperate for testing
* Sexually active patients must be willing to practice a reliable method of contraception during the study
Exclusion Criteria:
* Active viral infection (symptoms listed in section 9.0 of the protocol)
* LGMD2D subjects without weakness or functional loss
* Cardiomyopathy based on clinical exam and ECHO with ejection fraction less than 40%
* HIV infected
* Hepatitis A, B, or C infected
* Autoimmune diseases and immunosuppressive drugs (other than pulse methylprednisolone at time of gene transfer)
* Persistent leucopenia or leucocytosis (WBC less than or equal to 3.5 K/cu mm or at least 20.0 K/ cu mm) or neutrophils less than 1.5 K/ cu mm
* Concomitant illness or requirement for chronic drug treatment that in the opinion of the Principal Investigator creates unnecessary risks for gene transfer
* Pregnancy
* Abnormal laboratory values considered clinically significant
* Alcoholism (CAGE questionnaire), and laboratory tests such as GGT and MCV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT00494195
Study Brief:
Protocol Section:
NCT00494195