EUCTR2016-001867-35-SE进行中（未招募）1 期
Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TikoMed AB
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. Patient on a waiting list for islet transplantation
- •2. Male and female patients age 18 to 60 years of age.
- •3. Ability to understand and provide written informed consent.
- •4. Mentally stable and able to comply with the procedures of the study protocol.
- •5. Clinical history compatible with type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years at the time of enrolment.
- •6. Documented C-peptide <0.1 nmol/L before first islet transplantation (stimulated in response to a MMTT or other confirmatory method).
- •7. All subjects must have received medical treatment of their diabetes under the guidance from an experienced endocrinologist.
- •If not previously transplanted the patient must also have;
- •8. At least one episode of severe hypoglycemia in the past 1 year defined as an event with at least one of the following symptoms; memory loss, confusion, uncontrollable behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness, or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood/plasma glucose level < 54 mg/dl [3.0 mmol/L] or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
- •9. Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more.
- •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 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with prior organ transplants other than a kidney graft and/or islets. A previous pancreas transplant can be accepted if it failed within the first week due to thrombosis and the graft was removed.
- •2. Patients with body mass index (BMI) > 30.
- •3. Insulin requirement > 0.7 Unit/kg/day at screening.
- •4. Consistently abnormal liver function tests (> 1.5 x ULN on two consecutive measurements > 2 weeks apart) at screening.
- •5. Proliferative untreated diabetic retinopathy
- •6. Increased risk for thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5)
- •7. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- •8. Patients with increased cardiac risk defined as;
- •o unstable coronary artery disease requiring hospitalization or revascularization within 6 months prior to baseline visit
- •o chronic heart failure which required hospitalization 30 days prior to baseline visit
- •9. Patients with active infections, unless treatment is not judged necessary by the investigators
- •10. Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
- •11. Patients with active peptic ulcer disease, symptomatic gallstones or portal hypertension.
- •12. Patients who are pregnant or breastfeeding, or who intend to become pregnant.
- •13. Patients of childbearing potential not willing to use adequate double contraception with < 1% failure rate after the screening visit until the last visit.
- •14. Active alcohol or substance abuse
- •15. Patients with evidence of high-level sensitization (PRA> 50% with flow cytometry).
- •16. Patients with psychological conditions that make it unsafe to undergo islet transplantation or which preclude compliance with prescribed therapy
- •17. HbA1c > IFCC 100 mmol/mol, at screening.
- •18. Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with IBsolvMIR.
- •19. Patients participating in or having participated in any other clinical drug studies in the past four weeks.
- •20. History of bleeding disorders
- •21. History of severe hypersensitivity
- •22. Previous known heparin-induced thrombocytopenia (HIT)
- •23. Patients with severe hepatic or renal impairment
研究者
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