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Real-world study of standard and expanded ideal endpoints for patients with chronic hepatitis B

Real-world study of standard and expanded ideal endpoints for patients with chronic hepatitis B

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042448
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-31
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

HBV

Interventions

A group:Peg IFN a-2b
B group:Peg IFN a-2b combined with NAs

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-60 years, no gender limit (including 18 and 60 years old); 2) NAs has been treated for more than 1 year, HBsAg <= 1500 IU/ml, HBeAg-negative, and virological inhibition has been obtained; 3) B-ultrasound, color Doppler ultrasound, LSM and other imaging revealed no liver cirrhosis; 4) Within 24 hours before the first medication, urine or serum pregnancy test is negative (for women of childbearing age); 5) Willing to receive treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Combined with active hepatitis A, hepatitis C, hepatitis D, hepatitis E and/or HIV infection; or combined with drug-induced liver injury, genetic metabolic liver disease, autoimmune hepatitis, alcoholic liver disease; severe metabolic-related fatty liver should be reduced Enter the group only after pathological grade F; 2) Liver imaging examination revealed liver tumor during screening; 3) Patients diagnosed with hepatitis B cirrhosis, that is, those whose liver biopsy pathology conforms to the manifestations of cirrhosis, or conforms to 2 or more of the following 5 items, excluding non-cirrhotic portal hypertension: (1)Imaging The examination showed signs of liver cirrhosis and/or portal hypertension; (2)Endoscopy showed esophageal and gastric fundus varices; (3)The measurement of liver stiffness was consistent with cirrhosis; (4)Blood biochemical examination showed that the albumin level was reduced (3s longer than the control); (5)Routine blood examination showed platelet count < 100 x 10^9/L, etc.; 4) Pregnant or lactating women or patients who have pregnancy plans during the study period and are unwilling to use contraception; 5) Neutrophil count < 1.5 x 10^9/L or platelet count < 90 x 10^9/L. Creatinine is higher than 1.5 times the upper limit of normal; 6) I and my blood relatives (parents, siblings, etc.) have a history of serious mental illness, especially depression. Severe mental illness is defined as major depression or mental illness, suicide attempts, hospitalization due to mental illness, or a period of loss of ability due to mental illness; 7) A history of immune-mediated diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or Abnormally elevated levels of autoimmune antibodies; 8) Patients with severe diseases of the heart, lung, kidney, brain, blood and other important organs, as well as patients with other malignant tumors; 9) History of severe epilepsy or current anti-epileptic drug treatment. Control unstable diabetes, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or other evidence indicating retinopathy; 10) Any organ transplant history and existing functional transplants (except cornea or hair transplants); 11) Patients who are allergic to interferon and its drug components, and the investigator judges that they are not suitable for the application of interferon; 12) Patients considered by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
HBsAg;

Countries

China

Contacts

Public ContactZhao Weifeng

The First Affiliated Hospital of Soochow University

248958523@qq.com+86 13306218767

Outcome results

None listed

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