CLINICAL TRIALS PROFILE FOR AVALGLUCOSIDASE ALFA
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All Clinical Trials for avalglucosidase alfa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02032524 ↗ | Avalglucosidase Alfa Extension Study | Active, not recruiting | Genzyme, a Sanofi Company | Phase 2/Phase 3 | 2014-02-27 | Primary Objective: Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa Secondary Objective: Long-term effect of avalglucosidase alfa on pharmacodynamic and exploratory efficacy variables |
| NCT02782741 ↗ | Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease | Active, not recruiting | Genzyme, a Sanofi Company | Phase 3 | 2016-11-02 | Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12). |
| NCT02782741 ↗ | Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease | Active, not recruiting | Sanofi | Phase 3 | 2016-11-02 | Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12). |
| NCT03019406 ↗ | A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa | Active, not recruiting | Genzyme, a Sanofi Company | Phase 2 | 2017-10-12 | Primary Objective: To evaluate the safety profile of avalglucosidase alfa in patients with infantile-onset Pompe disease (IOPD) previously treated with alglucosidase alfa. Secondary Objective: To characterize the pharmacokinetic profile of avalglucosidase alfa and to evaluate the preliminary efficacy of avalglucosidase alfa in comparison to alglucosidase alfa. |
| NCT04910776 ↗ | Clinical Study for IOPD Participants Less Than or Equal to 6 Months of Age to Evaluate Efficacy and Safety of Enzyme Replacement Therapy (ERT) With Avalglucosidase Alfa | Recruiting | Sanofi | Phase 3 | 2021-09-01 | This is a single group, treatment, Phase 3, open-label study to assess efficacy, safety, pharmacokinetic (PK), pharmacodynamics (PD) of avalglucosidase alfa in male and female participants less than or equal to 6 months of age with IOPD. Study details include: - Study duration: Screening - up to 4 weeks; - Primary Analysis Period (PAP) - 52 weeks; - Extended Treatment Period (ETP) - 52 weeks; - Extended Long term Treatment Period (ELTP) - 104 weeks; 4-week follow-up period for a total study duration - up to 4.08 years. - Treatment duration: Up to 4 years - Visit frequency: every other week and potentially every week |
| NCT05164055 ↗ | Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase) | Not yet recruiting | Genzyme, a Sanofi Company | Phase 4 | 2022-02-15 | This long-term open label safety and efficacy study is intended to follow up, and to provide post-trial access to enzyme replacement therapy (ERT) with avalglucosidase alfa to patients with Pompe disease in France who have completed Study EFC14028, LTS13769, or ACT14132, from market authorization until reimbursement of avalglucosidase alfa in France or until January 2023, whichever comes first. - Study visit frequency: every 2 weeks |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for avalglucosidase alfa
Condition Name
| Condition Name for avalglucosidase alfa | |
| Intervention | Trials |
| Glycogen Storage Disease Type II | 2 |
| Glycogen Storage Disease Type II-Pompe's Disease | 2 |
| Glycogen Storage Disease Type II Pompe Disease | 1 |
| Glycogen Storage Disease Type II;Pompe's Disease | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for avalglucosidase alfa
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Clinical Trial Progress for avalglucosidase alfa
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Clinical Trial Sponsors for avalglucosidase alfa
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