Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia

Last updated: January 21, 2022
Sponsor: Fuzhou General Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT05203055
Peginterferon alpha-2b-HBV
  • Ages 18-60
  • All Genders

Study 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 that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. willing to receive the treatment and sign informed consent;
  2. 18-60 years old (including 18 and 60), both gender;
  3. HBsAg positive for at least 6 months and <1500IU/ml;
  4. ALT≤1xULN and no elevated ALT has been detected in history;
  5. HBV DNA detectable but<2000 IU/ml;
  6. HBeAg negative ;

Exclusion

Exclusion Criteria:

  1. 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 ;
  2. neuropsychiatric diseases, such as depression, anxiety, mania, schizophrenia, or afamily history of mental illness (especially with a history of depression ordepression tendency);
  3. co-infection of HCV, EBV, other hepatotropic viruses , non-hepatotropic viruses;
  4. alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease;
  5. Patients with moderate to severe steatohepatitis;
  6. possibility of liver cirrhosis that cannot be excluded
  7. hepatocellular carcinoma or AFP level>30ng/ml;
  8. Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome,serum creatinine> 1 x ULN at the time of screening;
  9. at screening, the neutrophil count is less than 1.5×10^9/L, and the platelet count isless than 90×10^9/L;
  10. Serum phosphorus level <0.7 mmol/L;
  11. Antinuclear antibody (ANA)>1:100;
  12. Autoimmune diseases, including thyroiditis, psoriasis and systemic lupuserythematosus;
  13. Endocrine system diseases, including thyroid diseases and diabetes mellitus;
  14. Uncontrolled blood pressure: SBP>160 mmHg or DBP >100 mmHg at the time of enrollment;
  15. Evidence of cardiovascular disease, existing congestive cardiac failure on physicalexam and/or acute coronary syndrome in the past 6 months;
  16. Severe retinopathy or other serious eye diseases;
  17. Organic disease or dysfunction;
  18. plan to receive an organ transplant or have already undergone an organ transplant;
  19. received standardized treatment with interferon or NA products before .
  20. allergic to interferon or pharmaceutical excipients, or meet any of thecontraindications in the experimental drug instructions;
  21. 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
    China

    Active - Recruiting

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