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A prospective and open study of chronic hepatitis B in immune-tolerant treated with nucleoside (acid) analogues.

A prospective and open study of chronic hepatitis B in immune-tolerant treated with nucleoside (acid) analogues.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPB-17013914
Enrollment
Unknown
Registered
2017-12-14
Start date
2017-12-20
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Chronic Hepatitis B

Interventions

Alone group: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.Chronic Hepatitis B 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 is postive and liver function is normal or less than twice the upper limit of normal; 4. Histology of liver biopsy is less than G2S2 or LSM=9.0KPa.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
HBV-DNA;Liver function;Renal function;serum marker for heptitis B;hepatosplenic ultrasonic examination;

Secondary

MeasureTime frame
Liver stiffness measurement;

Countries

China

Contacts

Public ContactLihua SUN

First Affiliated Hospital of Xinjiang Medical University

sunlihua8579@126.com+86 13659920315

Outcome results

None listed

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