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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of treatment-related adverse events

Secondary outcome measures

Biomarkers for Fabry disease

Cardiac assessment

Kidney function 1

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental open labelExperimental Treatment1 Intervention

pegunigalsidase alfa

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor

198 Previous Clinical Trials

311,817 Total Patients Enrolled

10 Trials studying Fabry Disease

255 Patients Enrolled for Fabry Disease

ProtalixLead Sponsor

18 Previous Clinical Trials

384 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots in this experiment open to new participants?

"Presently, this clinical trial is not enrolling patients. The trial's first posting was on September 20th, 2018 and the most recent update was on February 14th, 2020. There are 23 other trials for patients with fabry disease and 2 trials for pegunigalsidase alfa that are currently looking for participants."

Answered by AI

Could you explain who can and cannot participate in this experiment?

"This clinical trial is only for patients with fabry disease that are between 18-60 years old. A total of 110 participants will be accepted into the study."

Answered by AI

Could you please detail previous research on pegunigalsidase alfa?

"There are currently 2 clinical trials underway for pegunigalsidase alfa, both of which are in Phase 3. Most of the trial locations are in Iowa City, Iowa, but there are a total of 48 sites running these studies."

Answered by AI

Are elderly patients being accepted into this trial?

"The age range for patients that this trial is accepting is between 18-60 years old."

Answered by AI

How many research facilities are involved in this clinical trial?

"There are a total of 17 hospitals and medical research institutes conducting this trial. Some of the most notable locations are Massachusetts General Hospital in Boston, Institute of Metabolic Disease, Baylor Healthcare in Dallas, and University of California San Diego in La Jolla."

Answered by AI

Does this research build on previous studies?

"Pegunigalsidase alfa has had a long journey through clinical trials since 2018. After the first trial with 110 participants, the drug received Phase 3 approval in 2018. Now, there are 2 active studies involving pegunigalsidase alfa in 21 cities and 15 countries."

Answered by AI

How many people are partaking in this experiment at most?

"No, this study isn't currently looking for any more participants. The trial was posted on September 20th, 2018 and was last edited on February 14th, 2022. However, if you are seeking other studies, there are 23 clinical trials actively admitting participants with fabry disease and 2 trials for pegunigalsidase alfa that still need patients."

Answered by AI