CTRI/2024/01/062024尚未招募2 期
A double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of UB-ABC in adults with nonalcoholic fatty liver disease (NAFLD) - NI
nique Biotech Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Early diagnosis of NAFLD grading 1 2or 3 on abdominal ultrasound
- •Mild to moderate elevation of serum aminotransferase levels
- •Treatment naïve patients or patients not on any treatment for at least 4 weeks before inclusion
- •Patients with a body mass index between 25 and 40 kg per square meter
- •Patients with a history of controlled obesity or controlled diabetes
排除标准
- •Patients with an unstable metabolic condition such as weight change of more than 5 percent in the 3 months prior to inclusion
- •Patients with medical history of gastric bypass surgery or orthotopic liver transplant
- •Patients with uncontrolled diabetes mellitus type 2 at the time of screening
- •Patients with decompensated or severe liver disease as evidenced by one or more of the following, confirmed cirrhosis or suspicion of cirrhosis, esophageal varices, ascites, suspicion of portal hypertension, hospitalization for liver disease within 60 days of screening.
- •Patients with inflammatory bowel disease
- •Patients with diagnosed or suspected autoimmune diseases
- •Patients with a history of or active non liver malignancies
- •Patients with a significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis
- •Patients requiring anti-diabetic treatment or lipid lowering treatment
- •If patients are insulin dependent this treatment should have commenced at least 3 months prior to screening however changes in dose are permitted.
- •Patients with known hypersensitivity to any ingredients of the study treatment.
- •Patients with a positive test for human immunodeficiency virus antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
- •Patients with liver disease of other etiologies such as drug induced, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alpha1 antitrypsin deficiency or Wilsons disease.
- •Patients with a significant history of drug or alcohol abuse
- •Patients who have used dietary supplements rich in omega 3 or omega 6 fatty acids, probiotics, homeopathic or herbal drugs in the 4 weeks prior to baseline.
- •Patients who have participated in any other clinical study with an investigational drug within 3 months
- •Patients who are pregnant, planning pregnancy, breastfeeding
研究者
相似试验
进行中（未招募）
1 期
Phase I/II study of a new immunotherapeutic anticancer treatment administered in combination with standard therapy before surgery in patients with primary invasive breast cancer.eoadjuvant treatment of WT1-positive Stage II or III breast cancer. Patients will receive the WT1-A10 + AS15 ASCI in combination with standard neodjuvant therapy. Patients will be recruited in different cohorts according to the standard neoadjuvant treatment they will receive (aromatase inhibitor, chemotherapy or chemotherapy combined with trastuzumab).MedDRA version: 14.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-019909-42-GBGlaxoSmithKline Biologicals60
进行中（未招募）
不适用
AEUCTR2010-019909-42-DKGlaxoSmithKline Biologicals180
进行中（未招募）
不适用
Phase I/II study of a new immunotherapeutic anticancer treatment administered in combination with standard therapy before surgery in patients with primary invasive breast cancer.EUCTR2010-019909-42-DEGlaxoSmithKline Biologicals180
进行中（未招募）
1 期
Phase I/II study of a new immunotherapeutic anticancer treatment administered in combination with standard therapy before surgery in patients with primary invasive breast cancer.eoadjuvant treatment of WT1-positive Stage II or III breast cancer. Patients will receive the WT1-A10 + AS15 ASCI in combination with standard neodjuvant therapy. Patients will be recruited in different cohorts according to the standard neoadjuvant treatment they will receive (aromatase inhibitor, chemotherapy or chemotherapy combined with trastuzumab).MedDRA version: 14.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-019909-42-BEGlaxoSmithKline Biologicals250
进行中（未招募）
1 期
Clinical study evaluating if the patient is better and lives longer if bevacizumab is continued to be added to the standard treatment for worsening brain cancerMedDRA version: 14.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)GlioblastomaEUCTR2012-003138-17-ITF. Hoffmann-La Roche Ltd510