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Enzyme Replacement Therapy

Pegunigalsidase Alfa for Fabry Disease (Bright51 Trial)

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
Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically accepted, effective contraception method. These include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) supplemented with a barrier method (preferably male condom), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. Contraception should be used for 2 weeks after treatment termination.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once a year throughout the study at weeks 52, 104, 152, 200, 256, 312 and end of study week 364
Awards & highlights

Bright51 Trial Summary

This trial is testing how safe and effective a drug is in treating Fabry disease in adults who have completed another trial successfully.

Who is the study for?
This trial is for adult Fabry disease patients who completed the PB-102-F50 study. Participants must agree to use effective contraception if they or their partners can have children, and sign an informed consent. Those with conditions that could affect study compliance are excluded.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of a drug called pegunigalsidase alfa, given intravenously at a dose of 2 mg/kg every four weeks to adults with Fabry disease who previously finished another related trial.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for similar enzyme replacement therapies include allergic reactions, infusion-related reactions, pain in extremities, headache, fatigue, nausea, fever and chills.

Bright51 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use effective birth control during and for 2 weeks after the treatment.

Bright51 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once a year throughout the study at weeks 52, 104, 152, 200, 256, 312 and end of study week 364
This trial's timeline: 3 weeks for screening, Varies for treatment, and once a year throughout the study at weeks 52, 104, 152, 200, 256, 312 and end of study week 364 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
Clinical assessment
+5 more

Bright51 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
197 Previous Clinical Trials
311,963 Total Patients Enrolled
9 Trials studying Fabry Disease
301 Patients Enrolled for Fabry Disease
ProtalixLead Sponsor
18 Previous Clinical Trials
452 Total Patients Enrolled
9 Trials studying Fabry Disease
283 Patients Enrolled for Fabry Disease

Media Library

pegunigalsidase alfa (Enzyme Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03614234 — Phase 3
Fabry Disease Research Study Groups: Experimental open label
Fabry Disease Clinical Trial 2023: pegunigalsidase alfa Highlights & Side Effects. Trial Name: NCT03614234 — Phase 3
pegunigalsidase alfa (Enzyme Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03614234 — Phase 3

Frequently Asked Questions

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

How does pegunigalsidase alfa compare to other treatments in terms of safety?

"There is some clinical evidence to support the efficacy of pegunigalsidase alfa, as well as multiple rounds of data indicating its safety. For these reasons, our team has given it a score of 3."

Answered by AI

At how many facilities is this research being conducted?

"Emory University School of Medicine in Atlanta, Georgia, O & O Alpan in Fairfax, Virginia, Infusion Associates in Grand Rapids, Michigan are a few of the locations where this clinical trial is enrolling patients. There are also 8 other locations."

Answered by AI

Are new patients being recruited for this clinical trial?

"This particular clinical trial is not presently recruiting patients. The study was initially posted on November 6th, 2018, and was most recently updated on February 14th, 2022. There are 23 other clinical trials actively recruiting patients with fabry disease and 2 studies for pegunigalsidase alfa that are also recruiting patients."

Answered by AI

How many people are willing to try this new medication?

"Unfortunately, this particular trial is not currently enrolling patients. Although, there are 23 other trials for fabry disease and 2 studies for pegunigalsidase alfa that are currently looking for participants. This particular trial was originally posted on 11/6/2018 and was most recently edited on 2/14/2022."

Answered by AI

Are there previous instances of research involving pegunigalsidase alfa?

"Currently, there are two ongoing clinical trials researching pegunigalsidase alfa. These are both in Phase 3. Most of the investigations for pegunigalsidase alfa are based in Iowa City, Iowa; however, there are a total of 48 clinical trial locations for pegunigalsidase alfa."

Answered by AI

Does this research paper break new ground?

"Research surrounding pegunigalsidase alfa began in 2018. The first 110 participants were involved in a Phase 1 clinical trial sponsored by Protalix. After the success of the initial Phase 1 trial, the drug was approved for Phase 3 testing. Now, there are 2 live trials involving pegunigalsidase alfa with recruitment happening in 21 cities and 15 countries."

Answered by AI
~2 spots leftby Sep 2024