Status:
UNKNOWN
Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia
Lead Sponsor:
Fuzhou General Hospital
Conditions:
Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests th...
Eligibility Criteria
Inclusion
- willing to receive the treatment and sign informed consent;
- 18-60 years old (including 18 and 60), both gender;
- HBsAg positive for at least 6 months and \<1500IU/ml;
- ALT≤1xULN and no elevated ALT has been detected in history;
- HBV DNA detectable but\<2000 IU/ml;
- HBeAg negative ;
Exclusion
- For female participants: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of the contraception ;
- neuropsychiatric diseases, such as depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially with a history of depression or depression tendency);
- co-infection of HCV, EBV, other hepatotropic viruses , non-hepatotropic viruses;
- alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease;
- Patients with moderate to severe steatohepatitis;
- possibility of liver cirrhosis that cannot be excluded
- hepatocellular carcinoma or AFP level\>30ng/ml;
- Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, serum creatinine\> 1 x ULN at the time of screening;
- at screening, the neutrophil count is less than 1.5×10\^9/L, and the platelet count is less than 90×10\^9/L;
- Serum phosphorus level \<0.7 mmol/L;
- Antinuclear antibody (ANA)\>1:100;
- Autoimmune diseases, including thyroiditis, psoriasis and systemic lupus erythematosus;
- Endocrine system diseases, including thyroid diseases and diabetes mellitus;
- Uncontrolled blood pressure: SBP\>160 mmHg or DBP \>100 mmHg at the time of enrollment;
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months;
- Severe retinopathy or other serious eye diseases;
- Organic disease or dysfunction;
- plan to receive an organ transplant or have already undergone an organ transplant;
- received standardized treatment with interferon or NA products before .
- allergic to interferon or pharmaceutical excipients, or meet any of the contraindications in the experimental drug instructions;
- Participated in other interventional trials within 3 months before the screening or other conditions deemed unsuitable by the investigator.
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05203055
Start Date
December 10 2021
End Date
December 10 2023
Last Update
January 24 2022
Active Locations (1)
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1
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China, 350025