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 :
- 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