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China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD

NCT06666413 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-03-23

No results posted yet for this study

Summary

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.

Conditions

  • Glycogen Storage Disease Type II
  • Pompe's Disease

Interventions

DRUG

Avalglucosidase alfa

Pharmaceutical form: Sterile lyophilized powder Route of administration: IV infusion

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2028-05-02
Completion
2028-05-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666413 on ClinicalTrials.gov