EUCTR2013-003832-54-GB进行中（未招募）1 期
A MULTICENTRE EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND DURABILITY OF THE THERAPEUTIC EFFECT OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTI), IN THE TREATMENT OF CHOLESTATIC LIVER DISEASE IN PEDIATRIC SUBJECTS WITH ALAGILLE SYNDROME - IMAGINE STUDY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •To participate in this study, subjects must meet all of the following criteria:
- •1. Male or female, 12 months to 18 years of age.
- •2. Competent to provide informed consent and assent (per IRB/EC), as appropriate.
- •3. Completed participation in protocol LUM001-302.
- •4. Females of childbearing potential must have a negative urine pregnancy test [ß human chorionic gonadotropin (ß-hCG)] at the Baseline Visit.
- •5. Males and females of child-bearing potential who are sexually active, or are not currently sexually active during the study, but become sexually active during the period of the study and for 30 days following the last dose of study drug, must agree to use acceptable contraception during the study. Effective methods of contraception are considered to be:
- •a. Hormonal (e.g., contraceptive pill, patch, intramuscular implant or
- •injection); or
- •b. Barrier method, e.g., (a) condom with spermicide, or (b) diaphragm, with spermicide; or
- •c. Intrauterine device (IUD).
- •d. A sexual partner who is surgically sterilized.
- •6. Subjects are expected to have consistent caregiver(s) for the duration of the study.
- •7.Caregiver (and age appropriate subjects) must be able to read and understand English.
- •8. Caregivers (and age appropriate subjects) must have access to phone for scheduled calls from study site.
- •9. Caregivers (and age appropriate subjects) must be willing and able to complete a daily electronic diary (ItchRO) during the first consecutive 12 weeks of the study and then for 4 consecutive weeks following the Week 24 and Week 44 visits.
- •10. Caregivers (and age appropriate subjects) must digitally accept the licensing agreement in the ItchRO electronic diary software at the outset of the study.
- •Eligible subjects for the 52-week optional follow-up treatment period:
- •Subjects will be considered eligible for the 52-week optional follow-up treatment period if they have completed the protocol through the Week 72 visit with no safety concerns. Subjects who were discontinued due to safety reasons can be re-challenged if blood tests are back to relatively normal values for this patient population and subject does not meet any of the protocol’s stopping rules; the decision will be made by the investigator in consultation with the sponsor medical monitor. Subjects who have undergone a surgical disruption of the enterohepatic circulation will not be eligible to enter into the follow-up treatment period. Subjects who were discontinued for other reasons will be considered on an individual basis.
- •Protocol Amendment 5: Eligible subjects for the long-term optional follow-up treatment period
- •Subjects will be considered eligible for the long-term optional follow-up treatment period if they meet the following criteria:
- •1. The subject has either:
- •a. Completed the protocol through either the Week 124 or the ET visit with no major safety concerns.
- •b. Discontinued due to safety reasons judged unrelated to the study drug, and laboratory results have returned to levels acceptable for this patient population or individual and subject does not meet any of the protocol’s stopping rules at the time of entry into the follow-up period. The decision will be made by the investigator in consultation with the sponsor medical monitor. Subjects who were discontinued for other reasons will be considered on an individual basis.
- •2. Females of childbearing potential must have a negative urine or serum pregnancy test (ß- human chorionic gonadotropin [ß-hCG]) at the time of entry into the
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •1. Experienced an adverse event or serious adverse event (SAE) related to the study drug during the LUM001-302 study that led to the discontinuation of the subject from the LUM001-302 study.
- •2. Any conditions or abnormalities (including laboratory abnormalities) which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the subject, or interfere with the subject participating in or completing the study.
- •3. History or presence of gallstones or kidney stones.
- •4. History of non-adherence during the subject’s participation in the LUM001-302 study. Non-adherence is defined by dosing compliance of less than 80% in the LUM001-302 study, or earlier in the LUM001-303 study.
- •5. Unlikely to comply with the study protocol, or unsuitable for any other reason, as judged by the investigator.
- •Protocol Amendment 5: Eligible subjects for the long-term optional follow-up treatment period.
- •All exclusion criteria mentioned for the original study LUM001-303 apply upon re-entry into the long-term optional follow-up treatment period.
研究者
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