Last updated: January 21, 2022
Sponsor: Fuzhou General Hospital
Overall Status: Active - Recruiting
Phase
1/2
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
N/AClinical Study ID
NCT05203055
Peginterferon alpha-2b-HBV
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- For female participants: positive pregnancy test, presently breast-feeding, orunwillingness to use effective contraceptive measures for the duration of the study.For male participants: intent to procreate 3 months before or after the interventionor unwillingness to use effective measures of the contraception ;
- neuropsychiatric diseases, such as depression, anxiety, mania, schizophrenia, or afamily history of mental illness (especially with a history of depression ordepression 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 isless than 90×10^9/L;
- Serum phosphorus level <0.7 mmol/L;
- Antinuclear antibody (ANA)>1:100;
- Autoimmune diseases, including thyroiditis, psoriasis and systemic lupuserythematosus;
- 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 physicalexam 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 thecontraindications in the experimental drug instructions;
- Participated in other interventional trials within 3 months before the screening orother conditions deemed unsuitable by the investigator.
Study Design
Total Participants: 300
Study Start date:
December 10, 2021
Estimated Completion Date:
December 10, 2023
Connect with a study center
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian 350025
ChinaActive - Recruiting

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