EUCTR2020-004534-38-DE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in subjects with Alcoholic Hepatitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Able to provide written informed consent (either from subject or subject’s legally acceptable representative)
- •2. Onset of jaundice within prior 8 weeks
- •3. Average daily consumption of > 40 (females) or > 60 (males) grams alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made by the site investigator.
- •4. The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:
- •Serum total bilirubin > 3.0 mg/dL
- •50 < AST < 400 IU/L
- •ALT < 400 IU/L
- •AST/ALT > 1.5
- •NOTE: Labs values on the day of randomization must include serum total bilirubin > 3.0 mg/dL and AST and ALT < 400 IU/L in addition to the MDF and MELD values in inclusion 5 and 6 below.
- •5. Maddrey discriminant function (MDF) = 32 assuming a control prothrombin time of 12 seconds NOTE: If a local laboratory’s control time differs from 12 seconds then the local laboratory’s control time should be used.
- •6. Model for End-stage Liver Disease (MELD) score: 21-30
- •7. Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator’s discretion. Biopsy, if used as a diagnostic criterion, must have occurred during the current episode. NOTE: Liver biopsy is not a study procedure and will not be reimbursed.
- •8. Male or female subjects 18 years of age or older
- •9. Women of child-bearing potential (defined as females who are not surgically sterile [i.e. hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy] or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize highly effective birth control methods (i.e. methods that can achieve a failure rate of less than 1% per year when used consistently and correctly) throughout the study duration. Highly effective birth control methods that may be used are: 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 (IUD) (coil), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, sexual abstinence, or sexual activity limited to a vasectomized male partner with medical assessment of surgical success.
- •NOTE: Sexual abstinence should only be used as a contraceptive method if it is in line with the subject’s usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception.
- •10. Male subjects must agree to use a medically acceptable method of contraception/birth control and refrain from sperm donation throughout the study duration
- •11. Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution’s addiction specialists
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening. NOTE: Inhaled, topical, or local corticosteroid injections are permitted
- •2. Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens
- •3. Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
- •a. Subjects who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
- •b. Patients with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.
- •c. Patients with fungal infection of any kind cannot be considered for this trial.
- •4. Serum creatinine >2.5 mg/dL
- •5. Criterion removed as part of Protocol Amendment 2, but placeholder kept to maintain consistency in subsequent criteria numbering
- •6. Subjects undergoing continuous veno-venous hemodialysis (CVVH)
- •7. Uncontrolled gastrointestinal bleeding
- •8. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
- •9. Liver biopsy (if carried out) with findings not compatible with AH
- •10. Stage = 3 hepatic encephalopathy by West Haven criteria
- •11. Any severe concomitant cardiovascular, renal, endocrine, pulmonary (including ventilator dependent or COPD Global Obstructive Lung Disease [GOLD] stage III or IV), psychiatric disorder, or multi-organ failure
- •12. Other concomitant cause(s) of liver disease as a result of:
- •a. Autoimmune liver disease
- •b. Ischemic hepatitis
- •c. Wilson disease or alpha 1 antitrypsin deficiency
- •d. Vascular liver disease (e.g., Budd-Chiari)
- •e. Drug induced liver disease
- •f. Surface antigen positive hepatitis B (HBsAg+). NOTE: subjects with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded
- •g. Acute hepatitis A (if test performed per SOC)
- •h. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: subjects with stable chronic HCV or successfully treated HCV are not excluded
- •i. Acute hepatitis E (if test performed per SOC)
- •j. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)
- •k. Acute Epstein-Barr virus (EBV) viral hepatitis (if test performed per SOC)
- •NOTE: A spurious finding, such as the incidental finding of moderately elevated antinuclear antibody (ANA) or anti-smooth muscle antibody (ASMA) titer is not, by itself, a mandatory exclusion criterion unless accompanied by other evidence suggestive of a probable disease other than AH.
- •13. Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas)
- •14. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications
- •15. Existing or intended pregnancy or breast feeding
- •16. Participation in another interventional clinical trial within 30 days of Screening
- •17. History of organ transplantation, other than a corneal transplant
- •18. Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug
研究者
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