ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07409259 के लिए Acute-on-Chronic Liver Failure (ACLF) वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
PT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure प्रारंभिक चरण I 20 रैंडमाइज़्ड
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07409259 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन Acute-on-Chronic Liver Failure (ACLF) से जुड़ा हुआ है और यह एक प्रारंभिक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 1 जनवरी 2026 को हुई थी, और इसमें कुल 20 प्रतिभागियों के नामांकन की योजना है। Third Affiliated Hospital, Sun Yat-Sen University इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 अगस्त 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 13 फ़रवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The goal of this single-center, prospective, randomized controlled study is to evaluate the safety and efficacy of PT-MSCs Exosome Injection (code: PT-MSCs-EVS-2023-1) in treating patients with acute-on-chronic liver failure (ACLF). As an exploratory study with a small sample size, the primary focus is to observe safety outcomes and preliminary efficacy. The study will enroll patients aged 18 to 65 years who meet the...और दिखाएँ
आधिकारिक शीर्षक
Single-center, Prospective, Randomized Controlled Study of PT-MSCs Exosome Injection (Code: PT-MSCs-EVS-2023-1) in the Treatment of Chronic-to-acute Liver Failure
स्वास्थ्य स्थितियां
Acute-on-Chronic Liver Failure (ACLF)अन्य अध्ययन आईडी
- PL21
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-01-01
अंतिम अद्यतन प्रकाशित
2026-02-13
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-08-31
नामांकन (अनुमानित)
20
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
प्रारंभिक चरण I
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
Acute -On-Chronic Liver Failure
Bio-artificial liver
Exosome
Mesenchymal stem cells
Bio-artificial liver
Exosome
Mesenchymal stem cells
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
सक्रिय तुलना समूहControl Group Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. Artificial liver support or liver transplantation may be performed based on the investigator's clinical judgment. | standard comprehensive internal medical treatment, Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. |
प्रयोगात्मकStudy Group In addition to the standard treatment received by the control group, participants will receive PT-MSCs Exosomes (2×10\^11 particles per dose). | exosome injection For the Study Group, the exosome injection is diluted in 100 mL of normal saline and administered via intravenous infusion over a period of not less than 2 hours. Treatment is administered once every 3 days (on Day 1, Day 4, Day 7, and Day 10) for a total of 4 doses. standard comprehensive internal medical treatment, Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
12-Week Survival Rate | The percentage of participants who are alive at 12 weeks after enrollment. | 12 weeks |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Changes from the baseline in COSSH-ACLF II score | The Chinese Severe Hepatitis B Study Group (COSSH), based on a multicenter, open-label large cohort study, has established a novel prognostic scoring system for hepatitis B virus (HBV)-ACLF: COSSH-ACLF II s. The COSSH-ACLF II score is calculated as: 1.649×ln(INR) + 0.457×HE grade + 0.425×ln(neutrophils) + 0.396×ln(TBil) + 0.576×ln(urea) + 0.033×age. Theoretically, the score ranges from \~1.0 to \~15.0, though clinically observed values typically fall between 4.5 and 10.0. A score of less than 7.4 indicates a low-risk group, a score between 7.4 and 8.4 indicates a moderate-risk group, and a score greater than 8.4 indicates a high risk of 28- and 90-day mortality.Higher scores indicate greater severity of liver failure and a worse outcome. | 12 weeks |
Changes from the baseline in Child-Pugh score | The Child-Pugh Score assesses the prognosis of chronic liver disease based on five indicators: hepatic encephalopathy, ascites, total bilirubin, albumin, and PT/INR. The total score ranges from 5 to 15. Higher scores indicate worse liver function. (Classification: Grade A = 5-6 points; Grade B = 7-9 points; Grade C = 10-15 points.) | 12-weeks |
Change from Baseline in Clinical Symptom Score | Assessment of clinical symptoms including fatigue, anorexia, nausea, jaundice, and level of consciousness. Each symptom is graded on a scale from 0 (absent) to 3(severe). The individual scores are summed to calculate a total symptom score ranging from 0 to 15. Higher scores indicate more severe symptoms. | 12 weeks |
4-Week Survival Rate | The percentage of participants who are alive at 4 weeks after enrollment | 4 weeks |
The rate of participants with adverse outcomes at Week 4 and Week 12 | The rate of adverse outcomes, defined as death, treatment abandonment, or liver transplantation. | 4-week , 12-week |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Aged 18 to 65 years, regardless of gender.
- Diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to the diagnostic criteria in the "Guidelines for Diagnosis and Treatment of Liver Failure (2024 Edition)."
- COSSH-ACLF II score < 7.4.
- Participants must be fully informed about the study and voluntarily sign a written informed consent form prior to participation.
- Patients with chronic liver failure.
- Patients with active bleeding or Disseminated Intravascular Coagulation (DIC) that has not been effectively controlled.
- Known allergy to blood products or any medications/drugs used in the treatment protocol.
- Patients with circulatory failure.
- History of myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months.
- History of malignancy within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Pregnant or lactating women.
- Any other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in the trial.
Third Affiliated Hospital, Sun Yat-Sen Universityअध्ययन उत्तरदायी पक्ष
Liang Peng, मुख्य अन्वेषक, Professor, Third Affiliated Hospital, Sun Yat-Sen University
कोई संपर्क डेटा नहीं।
1 1 देशों में अध्ययन स्थान
Guangdong
Third Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China 510630, Guangzhou, Guangdong, 510630, China