EUCTR2021-000176-11-PL进行中（未招募）1 期
A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects with Short Bowel Syndrome-associated Intestinal Failure (SBS-IF) (DOLPHINS-2) - DOLPHINS-2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
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
- •1. Men or women, aged 18 years of age or older with intestinal failure resulting in SBS at the time of
- •signing the informed consent form (ICF) (or country’s legal age of majority if the legal age is
- •<18 years)
- •2. Capable of giving signed informed consent which includes compliance with the requirements and
- •restrictions listed in the ICF and in this protocol
- •3. Diagnosis of SBS defined as remaining small bowel in continuity of estimated <200 cm (equal to 79
- •inches) and with the latest intestinal resection being at least 6 months prior to Screening and
- •considered stable regarding the PN/IV need. No restorative surgery planned in the study period.
- •4. Require PN/IV at least 3 days per week for at least 12 months
- •5. Are willing to adhere to an individual predefined drinking menu during 48-hours recording periods
- •6. Have no colon polyps or had colon polyps removed by colonoscopy within 6 months prior to
- •7. (Only for the subjects who have a remnant part of colon). Not connected to the passage of foods and thereby dormant, can have an
- •abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI)
- •instead of colonoscopy (if standard of care at site), at the discretion of the Investigator.
- •Note: If the subject has undergone an upper GI with small bowel follow-through or an abdominal
- •ultrasound within 6 months before Screening, those test results will be acceptable for the screening
- •assessments. If the subject has not had these procedures within the 6 months before Screening, then
- •the procedures will be performed any time after providing informed consent with the results available
- •and reviewed before Day -1.
- •8. Have a stoma and able to separate stool and urine during the 48-hour measuring intervals
- •9. If the subject is not naïve to treatment with GLP-2 analog, the subject may be enrolled if all the
- •following criteria are met:
- •a. The duration of discontinuation of GLP-2 analog treatment should be at least 3 months prior
- •to Screening
- •b. Willing to provide medical history and/or record to recognize any medically significant
- •events during previous GLP-2 analog treatment
- •10. Have body weight =30 kg and body mass index (BMI) >18 kg/m2
- •11. Have at least 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing as demonstrated
- •by clinical assessment (e.g. Crohn's Disease Activity Index [CDAI], Harvey-Bradshaw Index [HBI])
- •12. Have stable body weight during the last 3 months prior to Screening (±5% variations allowed)
- •13. Sexually active female subjects of child-bearing potential must use medically acceptable methods of
- •birth control during the study and up to 60 days after the last dose of study drug (see Section 8.3.5 for
- •a list of acceptable birth control methods)
- •14. Sexually active male subjects must use medically acceptable methods of birth control during the study
- •and up to 60 days after the last dose of study drug (see Section 8.3.5 for a list of acceptable birth
- •control methods)
- •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 7
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any history of colon cancer.
- •2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma
- •or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
- •3. History of alcohol or drug abuse (within 1 year of screening)
- •4. Current participation in another study of an investigational agent or investigational device (catheter
- •lock trials are allowed) within 4 weeks prior to the signing the ICF
- •5. Have a body weight >100 kg
- •6. Have no clinically significant abnormal ECG findings (e.g., QTcF > 450 msec for males, QTcF> 470 msec for females, left bundle branch block) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- •7. Have repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure (BP) measurements =140 mm Hg.
- •8. Have a hospital admission within 1 month prior to Screening visit
- •9. Females who are pregnant, breastfeeding, or expect to become pregnant within the projected duration
- •of the study, starting with the Screening visit through 60 days after the final dose of study drug
- •10. Males who plan to father children within the projected duration of the study, starting with the
- •Screening visit through 60 days after the final dose of study drug
- •11. Have any of the following conditions:
- •a. Radiation enteritis,
- •b. Scleroderma,
- •c. Celiac disease (based on the review of medical history; subjects with normalized antibodies
- •and histology can be considered for enrollment),
- •d. Refractory/tropical sprue,
- •e. Pseudo-obstruction,
- •f. Active inflammatory bowel disease (IBD) [see inclusion criterion 11],
- •g. Pre-malignant/malignant change in colonoscopy biopsy or polypectomy,
- •h. Surgery scheduled during the study period,
- •i. Positive Human immunodeficiency virus (HIV) test,
- •j. Positive hepatitis B or C test,
- •k. Positive syphilis test,
- •l. Unstable immunological disorders such as rheumatoid arthritis or ulcerous colitis (If the
- •Investigator would like to enroll a subject with immunological disorders, he/she should
- •discuss this with the Sponsor and Medical Monitor before enrollment),
- •m. Significant, active, uncontrolled, untreated systemic diseases
- •12. Have unstable Crohn’s disease (CD) expected it to worsen over the course of the study and that
- •required initiation of treatment with biological therapy within 6 months prior to Screening
- •Note: Subjects treated with stable (unchanged dosage) of immunosuppressant therapy and biological
- •therapy are eligible for enrollment in the study.
- •13. Have IBD that required chronic systemic immunosuppressant therapy that had been introduced or
- •changed during the 3 months prior to Screening
- •14. Have unstable biological therapy (e.g., anti-tumor necrosis factor (TNF)-a, natalizumab, etc.) within 6
- •months prior to Screening, including significant changes in doses or switch of drug
- •15. Have unstable absorption due to cystic fibrosis or known deoxyribonucleic acid (DNA) abnormalities
- •(e.g., familial adenomatous polyposis, Fanconi-Bickel syndrome)
- •16. Have more than 4 hospitalizations related to PN/IV volume adjustments within 12 months of
- •17. Are not expected to be amenable to oral or tube feeding regimens
- •18. Have cardiac disease defined as decompensated heart failure (New York Heart Association Class IV),
- •unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening
研究者
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