EUCTR2021-004588-29-DE进行中（未招募）1 期
A randomized, single-blind trial to evaluate the safety and efficacy of apraglutide in subjects with Grade II to IV (MAGIC) steroid refractory gastrointestinal (GI) acute graft versus host disease on best available therapy - Proof-of-concept trial of apraglutide in GVHD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- VectivBio AG
- 入组人数
- 34
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. Signed informed consent for this trial prior to any trial specific assessment. A signed assent form will also be required for all subjects under the age of 18 years
- •2. Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40.0kg. Only subjects of 18 years and above will be included in Germany and France
- •3. Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
- •4. Evident myeloid and platelet engraftment (confirmed prior to trial medication start):
- •a) Absolute neutrophil count >1000/mm3
- •b) Platelets =20,000/mm3
- •Use of growth factor supplementation (granulocyte-colony stimulating factor and granulocyte-macrophage-colony stimulating factor) and transfusion support is allowed
- •5. Clinical diagnosis of lower GI-aGVHD, MAGIC Stage 1–4 prior to randomization. Suitable diagnostic procedures should be implemented to exclude alternative reasons for diarrhea; these include (but not limited to) fecal cultures and lower gut biopsy with histological
- •assessment for infectious diseases
- •6. Clinically confirmed SR lower GI-aGVHD defined as subjects administered SS, given alone, or combined with CNIs and either:
- •a) Disease progression based on organ assessment after 3 days of treatment with MP = 2 mg/kg/day ([or prednisone dose = 2.5 mg/kg/day] or equivalent) ± CNIs
- •b) Did not improve after 7 days of treatment with systemic MP = 2 mg/kg/day ([or prednisone dose = 2.5 mg/kg/day] or equivalent)
- •c) Progressed to a new organ after treatment with systemic MP = 2 mg/kg/day ([or prednisone dose = 2.5 mg/kg/day] or equivalent) for skin and upper GI-aGVHD,
- •d) Recurred during or after a steroid taper, Initial dose of SS should be = 2 mg/kg/day ([or prednisone dose = 2.5 mg/kg/day] or equivalent)
- •7. Treatment with SS plus RUX (RUX started concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation) .
- •8. Women of childbearing potential must agree to use a highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the EOT visit. Effective methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner. In Germany,
- •oral methods of hormonal contraception are to be combined with
- •another accepted method of contraception.
- •To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy, or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhea without an alternative medical cause, may be confirmed with follicle-stimulating hormone test in case of doubt). Women who do not engage in heterosexual intercourse will be allowed to join the trial without contraception following a thorough discussion with the Investigator to determine if this is feasible for the subject. The following methods are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, post-ovulation methods, withdrawal (coitus interruptus), sper
排除标准
- •1. Treatment with any systemic GVHD therapy (other than SS and RUX) including methotrexate and mycophenolate mofetil at the time of randomization/Day 0. Graft versus host disease prophylaxis (ciclosporin A, tacrolimus, sirolimus, everolimus, or anti-thymocyte globulin) is allowed.
- •2. Concomitant treatment with Janus kinase inhibitor therapy other than RUX at the time of randomization
- •3. Failed alloSCT due to relapse of underlying malignant disease
- •4. Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence
- •5. Ongoing participation in an interventional trial or administration of any investigational drug in less than its five half-lives prior to randomization/Day 0. Participation in observational or interventional trials involving supportive care such as probiotics or antiemetics, graft manipulation or transplant procedures, new combinations or new dosing of approved therapies for conditioning, prophylaxis, pre- or post-alloSCT and treatment of the underlying malignant disease are allowed after consultation with the Sponsor
- •6. Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or apraglutide excipients
- •7. Any use of enteral glutamine or growth factors such as native GLP-2, GLP-1, GLP-2 and GLP-1 analogs or known ADA within 6 months prior to randomization/Day 0
- •8. Inability to understand or unwillingness to adhere to the trial visit schedules and other protocol requirements, including subjects not willing to comply owing to drug/alcohol abuse or any condition that would interfere with full participation in the trial, including administration of trial medication and attending required trial visits; pose a significant risk to the subject; or interfere with interpretation of trial data
- •9. Less than 2 weeks anticipated survival at screening
- •10. Evidence of chronic renal disease as demonstrated by inadequate renal function, which is defined as estimated glomerular filtration rate (eGFR) <20 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology [CKD-EPI] formula) and is confirmed within 48 hours prior to randomization/Day 0)
- •11. Presence of decompensated liver cirrhosis Child Pugh Classes B and C
- •12. Clinically significant or uncontrolled cardiac disease including acute myocardial infarction within 6 months prior to randomization/Day 0, uncontrolled hypertension, congestive heart failure New York Heart Association Class III or IV
- •13. Requirement for vasopressor or inotropic support within 30 days prior to randomization/Day 0
- •14. Presence of uncontrolled cholestatic disorders or unresolved sinusoidal obstructive syndrome/veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to aGVHD and ongoing organ dysfunction)
- •15. Presence of relapsed primary malignancy or treatment for relapse after alloSCT
- •16. Requirement for unplanned immune suppression withdrawal as treatment of early malignancy relapse or low donor chimerism. Unclear remission states will be discussed with the Sponsor
- •17. Presence of newly diagnosed malignancies at screening or prior to randomization/Day 0
- •18. History of chronic gall bladder or bile duct inflammation or biliary obstruction unless a cholecystectomy was performed before screening
- •19. Presence or history of GI tumors (including the hepatobiliary system and pancreas) within the last five years before randomization; presence of colonic polyps that are not removed
- •20. Subjects that present or have a
研究者
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