Condition: Glycogen Storage Disease Type II · Pompe's Disease · Sponsor: Genzyme, a Sanofi Company
This is a single group, 52-week treatment, Phase 4, open-label, single-arm study to assess the safety and efficacy of avalglucosidase alfa IV infusion in male and female Chinese participants with IOPD who are treatment-naïve or were previously treated with ERT. Study details include: * The study duration: total study duration is approximately 64 weeks. * Screening period of up to 8 weeks * Treatment period of 52 weeks * Follow-up period of 4 weeks. (if the participant enrolls in another study or receives commercially available ERT, the follow-up period may be reduced from 4 to 2 weeks) * The number of visits will be 30, including 29 site visits and 1 phone call follow-up visit.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
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| Investigational Site Number: 1560001 | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06666413