BMN111を巡る効能と安全性に関するエクステンションスタディ/ An Extension Study to Evaluate the Efficacy and Safety of BMN 111

国際共同治験などの情報開示を行うClinical Traials.govにおいて、小児軟骨無形成症患者に投与するBMN-111の効能と安全性を巡るエクステンションスタディが実施される旨、2018年2月6日に掲載されました。

It has just posted an extension study to evaluate the efficacy and safety of BMN 111 on the the information website “Clinical Traials.gov “ that is disclosing International Clinical Trials on 6th Feb. 2018.

 

※エクステンションスタディとは

所定の投与期間を終了後も長期投与の有効性/安全性確認のために実施される臨床試験

※Extension Study

Extension study as a complementary survey accomplished as part of a research project

 

現状での想定実施国/施設はPhase3が先行して進められる豪・ビクトリアMurdoch Children’s Research Instituteです。

早くもポスト111-301(52週の投与)について継続試験が実施される見込みとなりました。

Now it is going to be proceed in just Australia, Victoria Murdoch Children’s Research Institute     that is most developing study site regarding Phase 3.

It is a remarkable post in terms of early notice of extension study to continue 111-301 that is dosed for 52 weeks.

 

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Outcome Measures

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Study DescriptionStudy Design Arms and InterventionsOutcome MeasuresEligibility CriteriaContacts and LocationsMore Information

 

Primary Outcome Measures :

  1. Change from baselines in mean annualized growth velocity [ Time Frame: Up to 5 years or near final adult height ]

Long term efficacy as measured by change in annualized growth velocity

 

ClinicalTrials.gov Identifier: NCT03424018
Recruitment Status : Enrolling by invitation

First Posted : February 6, 2018

Last Update Posted : February 6, 2018

 

Ages Eligible for Study: 6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

 

Locations

Australia, Victoria
Murdoch Children’s Research Institute
Parkville, Victoria, Australia, 3052

 

Study Design

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Study DescriptionStudy Design Arms and InterventionsOutcome MeasuresEligibility CriteriaContacts and LocationsMore Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children With Achondroplasia
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

 

Source: Clinical Traials.gov

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