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A prospective and open study of hepatitis B cirrhosis with low HBV-DNA burden treated with nucleoside (acid) analogues.

A prospective and open study of hepatitis B cirrhosis with low HBV-DNA burden treated with nucleoside (acid) analogues.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17013066
Enrollment
Unknown
Registered
2017-10-21
Start date
2017-11-20
Completion date
Unknown
Last updated
2017-11-20

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

Conditions

Hepatitis B cirrhosis

Interventions

Alone group:Treated with nucleoside (acid) analogues

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Cirrhosis patients with chronic HBV infection based on diagnostic criteria of 2015 China clinical practice guidelines of chronic hepatitis B (updated); 2. Males or females with age from 18 to 65 years old, capable of signing the informed consent; 3. Persistently positive HBsAg for more than 6 months (HBV DNA 2; 5. FibroTouch: ALT and total bilirubin are normal which LSM>=12.2KPa;Total bilirubin is normal and didn't antivirus treatment which LSM>=17.5KPa;Total bilirubin is abnormal which LSM>=29.2KPa; 6. Compensatory phase cirrhosis.;Inclusion criteria: 1. Cirrhosis patients with chronic HBV infection based on diagnostic criteria of 2015 China clinical practice guidelines of chronic hepatitis B (updated); 2. Males or females with age from 18 to 65 years old, capable of signing the informed consent; 3. Persistently positive HBsAg for more than 6 months (HBV DNA 2; 5. FibroTouch: ALT and total bilirubin are normal which LSM>=12.2KPa;Total bilirubin is normal and didn't antivirus treatment which LSM>=17.5KPa;Total bilirubin is abnormal which LSM>=29.2KPa; 6. Compensatory phase cirrhosis.

Exclusion criteria

Exclusion criteria: 1. Abdominal ultrasonography or CT indicate hepatocellular carcinoma; 2. Liver failure; 3. Decompensated cirrhosis; 4. Coinfection by hepatitis B virus, hepatitis C virus(Hepatitis C RNA positive), hepatitis D virus and human immunodeficiency virus (HIV) positive patients; 5. Suffered from drug-induced hepatitis, alcoholic liver disease, autoimmune hepatic disease and inherited metabolic liver disorders; 6. Combination with carcinoma, severe cardiopulmonary disease, ?connective tissue disease and organ transplantation patients; 7. Treating with nucleoside (acid) analogues before inclusion; 8. Poor compliance or information missing which may affect efficacy and safety.;Exclusion criteria: 1. Abdominal ultrasonography or CT indicate hepatocellular carcinoma; 2. Liver failure; 3. Decompensated cirrhosis; 4. Coinfection by hepatitis B virus, hepatitis C virus(Hepatitis C RNA positive), hepatitis D virus and human immunodeficiency virus (HIV) positive patients; 5. Suffered from drug-induced hepatitis, alcoholic liver disease, autoimmune hepatic disease and inherited metabolic liver disorders; 6. Combination with carcinoma, severe cardiopulmonary disease, ?connective tissue disease and organ transplantation patients; 7. Treating with nucleoside (acid) analogues before inclusion; 8. Poor compliance or information missing which may affect efficacy and safety.

Design outcomes

Primary

MeasureTime frame
HBV-DNA;AFP;hepatic decompensation rate;liver cancer rate;LSM;APRI score;;HBV-DNA;AFP;hepatic decompensation rate;liver cancer rate;LSM;APRI score;

Secondary

MeasureTime frame
HBsAg rate of decline;serum alanine aminotransferase;platelet count;Width of portal vein trunk;Spleen size;The extent of esophageal varices by gastroscopy;;HBsAg rate of decline;serum alanine aminotransferase;platelet count;Width of portal vein trunk;Spleen size;The extent of esophageal varices by gastroscopy;

Countries

China

Contacts

Public ContactLihua SUN;Lihua SUN ;

First Affiliated Hospital of Xinjiang Medical University ;First Affiliated Hospital of Xinjiang Medical University

sunlihua8579@126.com;sunlihua8579@126.com+86 13659920315;+86 13659920315

Outcome results

None listed

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