Status:
UNKNOWN
Development and Validation of Models to Predict Functional Cure in Patients With CHB After Peg-IFN Based Therapy
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
16-70 years
Brief Summary
Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HB...
Eligibility Criteria
Inclusion
- 1\. Sign an informed consent form;
- 2\. HBsAg (+), and the course of the disease exceeds six months;
- 3\. Age range from 16 to 70 years old;
- 4\. Female participants of childbearing age who had a negative pregnancy test before the trial and were able to take effective contraceptive measures;
- 5\. During the treatment period, within six months after the end of treatment, the patients agrees to use contraception
Exclusion
- 1\. Patients with a known history of allergy to Peg-IFNα and NAs;
- 2\. Co-infection with other virus such as HAV, HCV, HDV, HEV, HIV, etc;
- 3\. Patients with liver cirrhosis or a Child Pugh score of 7 or above;
- 4\. History or evidence of liver disease caused by other factors (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.);
- 5\. Pregnant or lactating women; Have a history of alcohol or drug abuse within the year prior to the trial enrollment screening;
- 6\. Neutrophil count\<1.5 × 109/L or hemoglobin\<100g/L or platelet count\<80 × 109/L; During the trial enrollment screening, serum creatinine was higher than the upper normal limit;
- 7\. A history of severe diseases in important organs and tissues such as the heart, brain, kidneys, retina, and muscles;
- 8\. Having a history of mental illness or a family history of mental illness, or a Hamilton Depression Scale score greater than 7 points;
- 9\. History of endocrine system or autoimmune diseases, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc;
- 10\. History of malignant tumors;
- 11\. During the trial enrollment screening, suspicious liver malignant tumors were detected by ultrasound, or AFP was greater than 100ng/mL or AFP cannot remain stable within 3 months prior to the experiment;
- 12\. Has a history of important organ transplantation;
- 13\. Other diseases that researchers believe are not suitable for inclusion.
Key Trial Info
Start Date :
January 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06196632
Start Date
January 6 2024
End Date
December 31 2025
Last Update
February 7 2024
Active Locations (1)
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1
Qilu hospital of Shandong University
Jinan, Shandong, China, 250012