NL-OMON53483撤回2 期
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients - Efficacy and safety of Allocetra-OTS in patients with sepsis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female >=18 years and <=90 years of age.
- •2. Diagnosis of Sepsis meeting Sepsis 3 criteria, defined by the presence of
- •organ dysfunction as identified by a total SOFA score >=5 points above
- •pre-admission (pre-illness) SOFA. Patients in septic shock with SOFA score up
- •to 13 may be included.
- •3. Initiation of antibiotics treatment for the suspected infection causing
- •4. Sepsis due to infection in at least one of the below organs:
- •4.1. Suspected, presumed or documented Community-Acquired Pneumonia (CAP).
- •4.2 Urinary tract infection/urosepsis
- •4.3. Acute cholecystitis
- •4.4. Acute cholangitis
- •4.5. Other Intra-Abdominal Infections (IAI)
- •4.6. Skin or soft tissue infection
- •5. Adequate infectious source control if necessary as determined by the
- •investigator, or source control is scheduled to be completed prior to IP
- •administration. In case source control will not be completed prior to IP
- •administration, Sponsor pre-approval is required for IP administration.
- •6. Signed written informed consent by the patient, or consent obtained
- •according to local regulations if the patient is unable to provide informed
- •7. Women of childbearing potential and all men must agree to use 2 methods of
- •an adequate contraception: One barrier method (e.g. diaphragm, or condom or
- •sponge, each of which are to be combined with a spermicide) and one hormonal
- •method (e.g. oral, transdermal patch, implanted contraceptives or intrauterine
- •device) prior to study entry and for the duration of study participation
- •through 4 weeks following IP administration. Subjects that are highly unlikely
- •to conceive (e.g. surgically sterile, postmenopausal, or not heterosexually
- •active) are exempt.
- •Non-childbearing potential is defined as (by other than medical reasons):
- •>=45 years of age and has not had menses for over 2 years.
- •<45 years of age and amenorrhoeic for > 2 years without a hysterectomy and
- •oophorectomy and a Follicle Stimulating Hormone (FSH) value in the
- •postmenopausal range upon pre-trial (screening) evaluation.
- •For women, post hysterectomy, bilateral oophorectomy, bilateral salpingectomy
- •or bilateral tubal ligation and vasectomy for men at least 6 weeks prior to
- •screening. Documented hysterectomy or oophorectomy must be confirmed with
- •medical records of the actual procedure or confirmed by ultrasound. Tubal
- •ligation must be confirmed with medical records of the actual procedure.
排除标准
- •1. Sepsis due to infection other than lung infection, UTI, IAI, skin/soft
- •tissue infection or sepsis patients where site of infection is unclear or
- •2. Patients on chronic dialysis.
- •3. Patients with acute pancreatitis (serum amylase > 3 ULN with clinical
- •abdominal pain).
- •4. Moribund patients at a high risk of death within 48 hours of treatment.
- •5. Weight < 50 kg of >120 kg or Body Mass Index (BMI) > 40 kg/m2.
- •6. SOFA score >= 14 at screening.
- •7. Patients with risk of nosocomial infection due to hospitalization or surgery
- •within 30 days prior to diagnosis of sepsis.
- •8. A known malignancy that is progressing or has required active treatment
- •within the past 3 months.
- •9. Patient with end-stage disease (unrelated to sepsis) defined as patients who
- •prior to the current hospitalization are expected to live < 6 months (as
- •assessed by the study physician).
- •10. Known active symptomatic severe acute respiratory syndrome coronavirus 2
- •(SARS-CoV-2) or chronic viral infections, such as, hepatitis B virus (HBV) or
- •hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other chronic
- •infections.
- •11. Chronic respiratory disease requiring home oxygen therapy on a regular
- •basis for > 6 h/day.
- •12. Known active upper gastrointestinal (GI) tract ulceration or hepatic
- •dysfunction including but not limited to biopsy-proven cirrhosis; End-stage
- •cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI
- •bleeding attributed to portal hypertension; or prior episodes of hepatic
- •failure, encephalopathy, or coma.
- •13. Known New York Heart Association (NYHA) class IV heart failure or unstable
- •angina, ventricular arrhythmias, acute coronary disease, or myocardial
- •infarction within six months prior to diagnosis of sepsis.
- •14. Known immunocompromised state or medications known to be immunosuppressive
- •as follows:
- •Hydrocortisone (for the treatment of septic shock) > 300 mg /d
- •Cyclophosphamide in the last 60 days;
- •Chemotherapy in the last 3 months;
- •Anti-tumor necrosis factor (TNF) agents, interleukin (IL)-1 receptor
- •antagonists (IL-1-RA), CTLA-4 fusion proteins, anti-CD20, anti-CD52, anti-IL-2,
- •anti-IL-6R, anti-IL-12/23, or integrin inhibitor agents within the last 8 weeks.
- •15. Organ allograft or previous history of stem cell transplantation.
- •16. Women who are pregnant or breastfeeding. Child-bearing potential females
- •must have a negative serum ß-hCG or hCG blood test at screening. Pregnancy
- •testing is not required for postmenopausal or surgically sterilized women.
- •17. Known hypersensitivity to any component of study treatment or excipients.
- •18. Participation in an interventional investigational study within 30 days
- •prior to diagnosis of sepsis.
- •19. Likely to be non-compliant or uncooperative during the study (e.g.
- •substance abuse such as drug or alcohol abuse, uncontrolled psychiatric
- •disorder or any chronic condition that may interfere with study conduct).
研究者
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