Last updated: November 3, 2021
Sponsor: Beijing 302 Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Hepatic Fibrosis
Hyponatremia
Scar Tissue
Treatment
N/AClinical Study ID
NCT05121870
NCRC-ID202105
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing to provide written informed consent;
- Aged 18 to 75 years (including 18 and 75 years), male or female;
- Patients diagnosed with decompensated liver cirrhosis based on clinical findings,laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one seriouscomplication, including esophageal and gastric varices bleeding, hepaticencephalopathy, ascites, spontaneous bacterial peritonitis and other seriouscomplications);
- Child-Turcotte-Pugh (CTP) score 7 to 12 points.
Exclusion
Exclusion Criteria:
- Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractoryascites or hepatorenal syndrome within 1 month prior to screening visit.
- Uncontrolled severe infection within 2 weeks of screening.
- Hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
- Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinueantiviral therapy during the study, or those who with antiviral therapy for HBV forless than 12 months.
- Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinueantiviral therapy during the study, or those who with antiviral therapy for HCV forless than 12 months.
- Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6months.
- Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months priorto study inclusion.
- Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stopalcohol abuse after inclusion.
- Severe jaundice (serum total bilirubin level ≥ 170μmol/L); Significant renalinsufficiency (serum creatinine ≥ 1.2 times upper normal limit); Severe electrolyteabnormality (serum sodium level < 125 mmol/L); Severe leukopenia (white blood cellcount < 1 × 10E9/L).
- Patients with biliary obstruction, hepatic vein, portal vein, splenic vein thrombosisand portal vein spongiosis.
- Patients with surgical history such as splenic cut-off flow and portal body shunt.
- Patients with confirmed or suspected malignancies.
- Patients with a prior history of major organ transplantation or complicated withsignificant disease of heart, lung, kidney, blood, endocrine and other systems.
- Drug abuse, drug dependence and patients who receive methadone treatment or withpsychosis.
- HIV seropositivity.
- Those who have received blood transfusion or other blood products within 1 month priorto screening visit.
- Pregnancy, lactation or with recent fertility plan.
- Highly allergic or have a history of severe allergies.
- Participants in other clinical trials within the last 3 months.
- Any other clinical condition which the investigator considers would make the patientunsuitable for the trial.
Study Design
Total Participants: 240
Study Start date:
September 01, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
The First Hospital of Lanzhou University
Lanzhou, Gansu
ChinaSite Not Available
Hainan hospital of Chinese PLA General Hospital
Sanya, Hainan
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, Hubei
ChinaSite Not Available
Shanghai Changzheng Hospital
Shanghai, Shanghai 200003
ChinaSite Not Available
Beijing 302 Hospital
Beijing,
ChinaActive - Recruiting
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