Active — Not RecruitingPhase 3

Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

United States29 participantsStarted 2018-11-13

Plain-language summary

The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have successfully completed PB-102-F50.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Completion of study PB-102-F50.
✓. The patient signs informed consent.
✓. 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.

What they're measuring

Evaluation of treatment-related adverse events

Timeframe: Throughout the study, 364 weeks

Trial details

NCT IDNCT03614234

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

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