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Cholestyramine sequestrate intestinal endotoxin and improve liver functions in HBV-positive cirrhotic patients

Cholestyramine sequestrate intestinal endotoxin and improve liver functions in HBV-positive cirrhotic patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058110
Enrollment
Unknown
Registered
2022-03-30
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV-positive cirrhotic

Interventions

Cholestyramine Group:Cholestyramine
Control Group:Entecavir dispersible tablet

Sponsors

Department of Gastroenterology, Clinical medical college and the first affiliated hospital of Chengdu medical college
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years; 2. HBsAg positive for 6 months; 3.HBV-DNA >2, 000IU/ml 4. Bile acid > 10umol/L; 5. Liver cirrhosis was confirmed by ultrasound, CT or MRI scanning or pathological biopsy.

Exclusion criteria

Exclusion criteria: 1. Unable to comply with or refused to sign the informed consent form; 2. Allergy history to colecenide; 3. Gastroscopy showed severe esophageal and gastric varices, or positive red sign (RC); 4. Have a history of bleeding from esophageal and gastric varices or hepatic encephalopathy; 5. Child Pugh score = 10; 6. Platelets 210 g/w, female alcohol intake > 140 g/w; 8. Other causes of liver disease, including autoimmunity, drug-induced liver injury, alcohol or genetic metabolic liver disease, or liver cancer; 9. Other systems such as circulatory, respiratory, urinary and other serious diseases or cancers; 10. Have a history of intestinal resection, splenectomy or embolization; 11. HIV infection or other organ dysfunction such as diabetes, renal insufficiency, autoimmune disease, thyroid disease; 12. Hepatitis A, C, D or E virus infection; 13. Pregnant or lactating women; 14. Use history of metformin; 15. Antibiotics were used within 7 days before enrollment; 16. Use immunomodulator within 30 days before enrollment; 17. Take probiotics; 18. Take antiviral drugs other than entecavir; 19. Participate in another clinical trial. 20. The researcher determined other conditions that are not suitable for this study; 21. Subjects can withdraw from the test at any time in the following circumstances: the patient has serious adverse events, the investigator thinks it is necessary to interrupt the test, and the patient needs to end the study period.

Design outcomes

Primary

MeasureTime frame
Serum endotoxin;

Secondary

MeasureTime frame
HBV assessment;Blood test for liver function;Liver fibrosis and cirrhosis assessment;Incidence of adverse events;

Countries

China

Contacts

Public ContactXiangsheng Fu

Department of Gastroenterology, Clinical medical college and the first affiliated hospital of Chengdu medical college

1358088785@qq.com+86 18202881072

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026