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A treatment strategy research of chronic hepatitis B based on the central immune organs

A treatment strategy research of chronic hepatitis B based on the central immune organs

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005266
Enrollment
Unknown
Registered
2014-06-11
Start date
2014-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

The national

Interventions

1:Entecavir+Pegylation of IFN
2:Entecavir+Pegylation of IFN+Thymopentin
3:Pegylation of IFN+Thymopentin

Sponsors

Beijing YouAn Hospital, Capital Medial University
Lead Sponsor

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years of age, gender not limited; 2. Comply with 2012 chronic hepatitis B prevention and treatment guidelines: HBsAg positive more than 6 months and: A) HBVDNA more than 2E+5IU/ml; B) the HBeAg positive; C) HBsAg concentration more than 1000 IU/ml (the determination is Roche electrochemical luminescence method and use the quantitative detection); 3. 2 x ULN less than ALT less than 10 x ULN, TBIL less than 2 x ULN. Or ALT less than 2 x ULN, but liver histology shows Knodell HAI more than 4 ,or inflammatory necrosis more than G2, or fibrosis more than S2; 4. To understand and voluntarily sign informed consent; 5. Able to comply with the research programs and visit plan in the scheme.

Exclusion criteria

Exclusion criteria: The patients who do not conform to the Interferon application, or conform to one of the following subjects will not be allowed to be included in the test: 1. The combination of other virus infection (HAV, HCV, HEV, EBV, CMV, HIV, etc.); 2. Other causes of liver disease, including alcoholic liver disease, nonalcoholic fatty hepatitis, drug-induced hepatitis, autoimmune hepatitis, etc.; 3. With liver cancer, serious liver disease and other important viscera dysfunction; 4. Pregnancy and lactation female patients; 5. Have the history of the main organ transplantation; 6. Routine blood neutrophils count less than 1.0*10^9/L; The platelet count less than 50*10^9/L; 7. Have other severe autoimmune diseases; Spirit, nervous system disease; Serious blood system diseases; Severe renal disease; The uncontrollable digestive disease; Endocrine diseases; Severe respiratory disease; Diseases of the cardiovascular system; Retinopathy; Used nucleoside antiviral drugs in half a year; And clinical doctors do not think suitable as participants.

Design outcomes

Primary

MeasureTime frame
HBV DNA quantitative;Liver function;Abdominal ultrasound;Breast enhancement CT;Five makers of hepatitis B;

Countries

China

Contacts

Public ContactJun Lv
lujun98@ccmu.edu.cn+86 13661381489

Outcome results

None listed

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