EUCTR2018-000202-37-FR进行中（未招募）1 期
A Phase 3b Open-label Study of the Anti-FGF23 Antibody, Burosumab (KRN23) in Adult Patients with X-linked Hypophosphatemia (XLH)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
入选标准
- •1) Subjects who provide written informed consent after the nature of the study has been
- •explained, and prior to any research-related procedures.
- •2) Subjects who successfully completed Study UX023-CL303 or UX023-CL304. Subjects
- •should have completed the study up to and including the final study visit. Subjects who were
- •prematurely discontinued due to adverse events, Sponsor’s decision or Investigator’s decision
- •will not be enrolled in this study. Subjects’ enrolment is not dependent on any response to
- •Primary or Secondary endpoints in studies UX023-CL303 or UX023-CL304.
- •3) Willing to provide access to prior medical records for the collection of historical growth,
- •biochemical and radiographic data, and disease history.
- •4) Must, in the opinion of the investigator, be willing and able to complete all aspects of the
- •study, adhere to the study visit schedule and comply with the assessments.
- •5) Females of child-bearing potential must have a negative urine pregnancy test at Screening and
- •be willing to have additional pregnancy tests during the study. Females considered not to be of
- •child-bearing potential include those who have been in menopause for at least two years prior
- •to Screening, or have had tubal ligation at least one year prior to Screening, or have had a total
- •hysterectomy or bilateral salpingo-oophorectomy. If sexually active, male and female subjects
- •must be willing to use one highly effective method of contraception for the duration of the
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1) Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted
- •normal limits and deemed as clinically significant in the opinion of the investigator.
- •2) Presence of a concurrent disease or condition that would interfere with study participation
- •or affect safety in the opinion of the investigator or Sponsor.
- •3) Use of any investigational product other than burosumab or investigational medical device
- •within 30 days prior to Screening, or requirement for any investigational agent prior to
- •completion of all scheduled study assessments.
- •4) Subjects with major protocol deviations in Study UX023-CL303 or UX023-CL304 which
- •in the view of the investigator places the subject at high risk of poor treatment compliance or
- •of not completing the study.
研究者
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