Microdystrophin Gene Transfer Study in Adolescents and Children With DMD (NCT03368742) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Microdystrophin Gene Transfer Study in Adolescents and Children With DMD
United States12 participantsStarted 2017-12-06
Plain-language summary
This is a controlled, open-label, single-ascending dose study to evaluate the safety and tolerability of SGT-001 in adolescents and children with Duchenne muscular dystrophy (DMD). Participants will receive a single intravenous (IV) infusion of SGT-001 and will be followed for approximately 5 years.
The protocol was amended to drop the control arm after 4 participants were dosed.
Who can participate
Age range4 Years – 17 Years
SexMALE
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Inclusion Criteria:
* Established clinical diagnosis of DMD and documented dystrophin gene mutation predictive of DMD phenotype
* Confirmed absence of dystrophin as determined by muscle biopsy (ambulatory participants)
* Anti-AAV9 antibodies below protocol-specified thresholds
* Stable cardiac and pulmonary function
* Adolescents: non-ambulatory by protocol-specified criteria
* Children: ambulatory by protocol-specified criteria
* Stable daily dose (or equivalent) of oral corticosteroids ≥ 12 weeks
Exclusion Criteria:
* Prior or ongoing medical condition or physical examination, ECG or laboratory findings that could adversely affect participant safety, compromise completion of treatment and follow-up, or impair assessment of study results
* Abnormal liver function
* Abnormal renal function
* Clinically significant coagulation abnormalities
* Impaired cardiovascular function based on cardiac MRI or ECHO
* Impaired respiratory function based on FVC % predicted or need for daytime ventilatory support
* Significant spinal deformity or presence of spinal rods
* Body mass index ≥ 95th percentile for age
* Exposure to another investigational drug within 3 months or 5 half-lives prior to screening
* Exposure to drugs affecting dystrophin or utrophin expression within 6 months prior to screening
Additional inclusion/exclusion criteria may apply.
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)