111-901 going forward to next study

The study code 111-901 which is “Multicenter, Multinational Clinical Assessment Study for Pediatric Patients With Achondroplasia” has updated on the website ClinicalTrials.gov on 12th June.

For past 4 years the main purpose had been to collect consistent baseline growth measurements on pediatric patients with Achondroplasia being considered for subsequent enrollment in Study 111-202. But now it chancegd into considered for subsequent enrollment in future studies sponsored by BioMarin. Furthermore eligibility had been under 13 years, but it this update show for under 16 years patients. Consequently the estimated enrolment changed into 250 from 200. This study must be proceed next stage.

スタディコード(111-901)「小児軟骨無形成症患者の多施設・多国間臨床評価」がClinicalTrials.govにおいて再度更新されました。(6月12日現在)

過去4年間、このスタディの目的は、対フェーズ2(111-202)時の成長速度を比較すべく、ベースラインを定めるためのデータ収集でした。更に参加資格の上限に関してこれまで13歳であったものが、今回16歳にまで引き上げられました。そして、当該スタディはこれまでフェーズ2の要件とされていたものが、新たにスポンサー企業より指定されるスタディへと要件定義が変更されたものです。結果、推定参加者数が200人から250人と増加しました。着々と次のステージへ進んでいることがわかります。

《Before Updated》                                         《Post Updated》

Purpose

Multicenter, multinational study to collect consistent baseline growth measurements on pediatric patients with Achondroplasia being considered for subsequent enrollment in Study 111-202. No study drug is administered. Multicenter, multinational study to collect consistent baseline growth measurements on pediatric patients with Achondroplasia being considered for subsequent enrollment in future studies sponsored by BioMarin. No study drug is administered.

Primary Outcome Measures:

Assessed every 3 months for up to 60 months Assessed every 3 months for up to 84 months

Estimated Enrollment:

200 250

Study Population:

Approximately 200 patients will be enrolled. Patients aged 2 to 13.5 years, inclusive, on the date of consent will be enrolled. Patients aged 0 to < 2 years on the date of consent may also be enrolled, the timing of which will be at the discretion of the sponsor. Approximately equal numbers of boys and girls will be enrolled. Approximately 250 patients will be enrolled. Patients from birth to < 17 years on the date of consent will be enrolled. Patients aged 0 to < 4.5 years on the date of consent may also be enrolled, the timing of which will be at the discretion of the sponsor. Approximately equal numbers of boys and girls will be enrolled.

Sourse: clinicaltrials.gov

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