EUCTR2018-000550-21-DE进行中（未招募）1 期
Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - Prolia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects are eligible to be included in the study only if all of the following criteria apply:
- •-Subject has provided informed consent/assent prior to initiation of any Study 20170534 specific activities/procedures. Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- •- Subject was enrolled in Study 20130173 and:
- •? - completed the 20130173 EOS visit (regardless of completing or ending investigational product early).
- •?- Subjects who do not reconsent to transition to 3-Month Dosing Regimen on Study 20130173 are also eligible for enrollment
- •? Early terminated from Study 20130173 as a result of meeting BMD Z-score investigational product stopping criteria and was required to early terminate from the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 114
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are excluded from the study if any of the following criteria
- •Prior/Concomitant Therapy
- •-Treatment with any prohibited proscribed medications during Study
- •20130173 while receiving denosumab. Eligibility into study treatment
- •with alternative osteoporosis medication/s of investigator's choice,
- •follow guidelines per the specific alternative osteoporosis medication/s
- •selected. For subjects off-treatment (observation only), no prohibited
- •medications apply.
- •Prior/Concurrent Clinical Study Experience
- •-Subjects currently receiving treatment in another investigational device
- •or drug study other than Study 20130173. Other investigational
- •procedures while participating in this study are excluded.
- •Other Exclusions
- •-For subjects expected to receive investigational product (denosumab)
- •at study day 1:
- •-Female subject is pregnant or breastfeeding or planning to become
- •pregnant or breastfeed during treatment and for an additional 5 months
- •after the last dose of denosumab. Females of childbearing potential
- •(Tanner Stage = 2) should only be included in the study after a negative
- •highly sensitive urine pregnancy test. For study
- •treatment with alternative osteoporosis medication/s of investigator's
- •choice, follow guidelines per the specific alternative osteoporosis
- •medication/s selected. For subjects off-treatment (observation only), no
- •exclusion applies.
- •-For subjects expected to receive investigational product (denosumab)
- •at study day 1:
- •-Female subjects of childbearing potential unwilling to practice true
- •sexual abstinence (refrain from heterosexual intercourse) or use 1
- •highly effective method of contraception during treatment and for an
- •additional 5 months after the last dose of investigational product (IP)
- •(denosumab). For study treatment with alternative osteoporosis
- •medication/s of investigator's choice, follow contraception guidelines
- •per the specific alternative osteoporosis medication/s selected. For
- •subjects not receiving any IP (observation only), no contraception
- •-History or evidence of any other clinically significant disorder, condition
- •or disease (with the exception of those outlined above) that, in the
- •opinion of the investigator or Amgen physician, if consulted, would pose
- •a risk to subject safety or interfere with the study evaluation,
- •procedures or completion.
研究者
相似试验
进行中（未招募）
1 期
Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaOsteogenesis Imperfecta (OI)MedDRA version: 20.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-000550-21-GBAmgen Inc150
进行中（未招募）
1 期
Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaOsteogenesis Imperfecta (OI)MedDRA version: 20.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-000550-21-ESAmgen Inc150
进行中（未招募）
1 期
Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Children/Young Adults with OsteogenesisImperfectaEUCTR2018-000550-21-ITAMGEN INC.75
进行中（未招募）
1 期
Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaOsteogenesis Imperfecta (OI)MedDRA version: 20.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-000550-21-PLAmgen Inc150
进行中（未招募）
1 期
Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaEUCTR2018-000550-21-FRAmgen Inc150