TerminatedPhase 3

A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency

Stopped: Sponsor Decision

Canada3 participantsStarted 2023-04-04

Plain-language summary

This is an open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.

Who can participate

SexALL

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Inclusion criteria

✓. Prior enrollment in pegzilarginase clinical studies, with completion of treatment or continued dosing as of the study termination date
✓. Written informed consent by subject/parent/legal guardian, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
✓. Negative pregnancy test within 7 days prior to dosing in childbearing subjects if they are sexually active
✓. If the subject (male or female) is engaging in sexual activity that could lead to pregnancy, must be surgically sterile, post-menopausal (female), or must agree to use a highly effective method of birth control during the study and for a minimum of 30 days after the last study drug administration. Highly effective methods of contraception include combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation, progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device, or intrauterine hormone-releasing system

Exclusion criteria

✕. Subjects with acute or ongoing hyperammonemia within 6 weeks of the first dose
✕. Subjects with medical conditions or underlying issues that, in the opinion of the Investigator, would preclude participation in the study

What they're measuring

Treatment emergent adverse events

Timeframe: Baseline through week 54

Trial details

NCT IDNCT05676853

SponsorAeglea Biotherapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-27

View on ClinicalTrials.gov More Arginase I Deficiency trials