This multicenter open-label extension study conducted in France is designed to provide ATH434 orally BID to eligible patients who completed the Phase 2 study ATH434-201, and who may benefit from this treatment according to the evaluation by the Investigator.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Completed Alterity protocol ATH434-201.
* Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.
Exclusion Criteria:
* Discontinued prior ATH434 treatment (ATH434-201) for any reason.
* Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the Investigator's opinion.
Primary outcome measure(s)
Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Baseline to completion of study treatment, an average of 1 year. All AEs will be reviewed at every participant contact and documented in the CRF. All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.
Change From Baseline in Clinical Laboratory Parameters — Baseline to completion of study treatment, an average of 1 year. Clinical laboratory parameters include hematology and blood chemistry panels.
Change From Baseline in Vital Signs — Baseline to completion of study treatment, an average of 1 year. Vital signs include blood pressure, pulse, temperature, and respiration rate.
Duration of Exposure to ATH434 — Baseline to completion of study treatment, an average of 1 year. Total duration of treatment with investigational product per participant.
Cumulative Dose of ATH434 — Baseline to completion of study treatment, an average of 1 year. Total cumulative dose of investigational product administered per participant.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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