EUCTR2021-003149-39-ES进行中（未招募）1 期
A PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 63
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
- •Age and Sex:
- •1.Male and female participants between the ages of =15 months to =12 years inclusive, at Visit 1 (Screen 1).
- •Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- •Type of Participant and Disease Characteristics:
- •2.Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests lifestyle considerations and other study procedures.
- •3.Completed the C4181005 Phase 2 study.
- •4.Able to stand independently for height measurements (if =2 years of age at enrollment).
- •Informed Consent:
- •5.Capable of giving signed informed consent/assent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •6.Following receipt of oral and written information about the trial, the child (depending on local IRB/independent EC requirements) must provide assent, and 1 or both (according to local regulations) parent(s) or legal guardians of the child must provide signed informed consent before any trial-related activity is carried out.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 63
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical Conditions:
- •1.Presence of co-morbid conditions or circumstances that, in the opinion of the investigator, would affect interpretation of growth data or ability to complete the trial procedures.
- •2.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •3.Presence of severe obesity (BMI >95th percentile on Hoover-Fong BMI charts) [Hoover-Fong et al, 2008].
- •4.Known closure of long bone growth plates (cessation of height growth).
- •5.Body weight = 45 kg.
- •6.History of hypersensitivity to study intervention or any excipients.
- •Prior/Concomitant Therapy:
- •7.Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s). Refer to Section 6.8 Concomitant Therapy.
- •8.History of any prior treatment with human growth hormone or related products (including IGF-1).
- •9.History of receipt of any treatment that are known to potentially affect growth (including oral steroids >5 days in the last 6 months, high dose inhaled corticosteroids (>800 µg/day beclomethasone equivalent) and medication for attention deficit hyperactivity disorder).
- •10.History of limb lengthening surgery (defined as distraction osteogenesis/Ilizarov/callostasis technique following submetaphyseal osteotomy to extend bone length).
- •11.Any limb lengthening/corrective orthopaedic surgery planned at any point during the trial period.
- •12.Less than 6 months since fracture or surgical procedure of any bone determined from the screening visit date.
- •13.Presence of any internal guided growth plates/devices.
- •14.History of removal of internal guided growth plates/devices within less than 6 months.
- •Prior/Concurrent Clinical Study Experience:
- •15.History of receipt of any other (except recifercept) IP for achondroplasia or that may affect growth/interpretation of growth parameters.
- •16.Previous administration with an investigational drug (not for achondroplasia/growth affecting) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Other Exclusions:
- •17.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
研究者
相似试验
进行中（未招募）
1 期
Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in achondroplasiaMedDRA version: 20.0Level: LLTClassification code 10000452Term: AchondroplasiaSystem Organ Class: 100000004850AchondroplasiaEUCTR2021-003149-39-BEPfizer Inc.63
进行中（未招募）
1 期
Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in achondroplasiaMedDRA version: 20.0Level: LLTClassification code 10000452Term: AchondroplasiaSystem Organ Class: 100000004850AchondroplasiaEUCTR2021-003149-39-PTPfizer Inc.35
进行中（未招募）
1 期
Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in achondroplasiaAchondroplasiaMedDRA version: 25.0Level: LLTClassification code 10000452Term: AchondroplasiaSystem Organ Class: 100000004850EUCTR2021-003149-39-DKPfizer Inc.63
未知
不适用
A PHASE 2, OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY OF MEDI-546 IN ADULTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS-M32 Systemic lupus erythematosusM32Systemic lupus erythematosusPER-038-13MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,40
进行中（未招募）
1 期
Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseEUCTR2017-004997-32-ITGENENTECH, INC.320