Trial Profile

Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil (OK432) Sclerotherapy-Multicenter Trial

Status: Completed

Phase of Trial: Phase II/III

Latest Information Update: 17 Mar 2021

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At a glance

Drugs Picibanil (Primary)
Indications Lymphangioma
Focus Registrational; Therapeutic Use

Most Recent Events

11 Mar 2021 According to a Protara Therapeutics media release, in connection with company's request to discuss a potential BLA submission for TARA-002 in LMs, the FDA Division of Vaccines and Related Products has requested a CSR summarizing the totality of this study. The Company has submitted the CSR to the FDA and continues to prepare for a potential BLA filing in the second half of 2021, or to initiate additional clinical work as required.
30 Mar 2015 New trial record

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