Status:
UNKNOWN
The Study on Clinical Outcome and Treatment Optimization of Chronic Hepatitis B Patients With Hypoviremia
Lead Sponsor:
Beijing Ditan Hospital
Collaborating Sponsors:
Beijing 302 Hospital/5th Medical Center of Chinese PLA General Hospital
Beijing YouAn Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16-60 years
Brief Summary
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is relate...
Detailed Description
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of liver cancer, which brings huge economic burden and life threat to our people. 84% - 92% of hepatocellula...
Eligibility Criteria
Inclusion
- Aged from 16 to 60;
- The positive time of HBsAg was 6 months,
- 48 weeks of treatment with ETV, TDF or TAF, including HBeAg positive and negative patients;
- High sensitive reagent was used to confirm that the low level of serum HBV DNA was 20 IU / ml-2000 IU / ml.
- Good compliance and sign informed consent.
Exclusion
- Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis;
- Those who have used interferon within 6 months;
- at the same time, it is associated with other virus infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, AIDS virus, etc;
- in addition to hepatitis B, there are other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, serious complications of diabetes and adrenal diseases), immune deficiency diseases, and severe infections; Active or suspected malignant tumor or history of malignant tumor;
- 6 months before enrollment or currently receiving corticosteroids, immunosuppressants and chemotherapeutic drugs;
- Complicated with alcoholic liver disease, autoimmune liver disease and other liver diseases;
- HBV resistant patients;
- Other situations that the researcher believes are not suitable for inclusion.
- PegIFN α Treatment contraindications:
- Prohibited for known pairs α- Patients who are allergic to interferon, E. coli products, polyethylene glycol or any component of this product;
- It is forbidden to be used in patients with autoimmune hepatitis;
- Pregnant and lactating women;
- Central nervous system diseases, mental diseases, uncontrolled epilepsy, non withdrawal of alcohol / drug abuse, decompensated liver cirrhosis, symptomatic heart disease, uncontrolled autoimmune diseases and severe thyroid function diseases;
- Absolute neutrophil count before treatment ≤ 1.0 × 109 / L, platelet ≤ 80 × 109/L。
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05357183
Start Date
January 1 2022
End Date
December 1 2024
Last Update
May 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, China, 100015