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Enzyme Replacement Therapy

Pegunigalsidase Alfa for Fabry Disease

Phase 3
Waitlist Available
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 months to end of the study, 7 years. for patients from pb-102-f20 at 3 and 6 months.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a drug to treat Fabry disease in adults who have completed other trials successfully. The drug will be given every other week to see how safe and effective it is.

Who is the study for?
This trial is for adult patients with Fabry Disease who completed previous studies (PB-102-F20, PB-102-F03, or PB-102-F30) and consent to participate. They must use effective contraception if they can have children. Those with conditions affecting study compliance are excluded.
What is being tested?
The trial tests the long-term safety and effectiveness of pegunigalsidase alfa at a dose of 1 mg/kg given intravenously every two weeks to adults with Fabry Disease who participated in earlier related trials.
What are the potential side effects?
While specific side effects aren't listed here, common ones for enzyme replacement therapies like pegunigalsidase alfa may include allergic reactions, infusion-related discomfort, headache, nausea, fatigue and potential immune response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 months to end of the study, 7 years. for patients from pb-102-f20 at 3 and 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 months to end of the study, 7 years. for patients from pb-102-f20 at 3 and 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of treatment-related adverse events
Secondary study objectives
Biomarkers for Fabry disease
Cardiac assessment
Kidney function 1
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental open labelExperimental Treatment1 Intervention
pegunigalsidase alfa

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
202 Previous Clinical Trials
312,932 Total Patients Enrolled
11 Trials studying Fabry Disease
355 Patients Enrolled for Fabry Disease
ProtalixLead Sponsor
18 Previous Clinical Trials
392 Total Patients Enrolled
9 Trials studying Fabry Disease
215 Patients Enrolled for Fabry Disease

Media Library

pegunigalsidase alfa (Enzyme Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03566017 — Phase 3
Fabry Disease Research Study Groups: Experimental open label
Fabry Disease Clinical Trial 2023: pegunigalsidase alfa Highlights & Side Effects. Trial Name: NCT03566017 — Phase 3
pegunigalsidase alfa (Enzyme Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03566017 — Phase 3
~1 spots leftby Dec 2024
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