Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection

Beijing Kawin Technology Share-Holding Co., Ltd.34 sites in 1 country336 target enrollmentDecember 28, 2021

ConditionsChronic Hepatitis B Virus Infection

InterventionsPeginterferon Alfacon-2 Peginterferon Alfacon-2 placebo

Overview

Phase: Phase 3
Intervention: Peginterferon Alfacon-2
Conditions: Chronic Hepatitis B Virus Infection
Sponsor: Beijing Kawin Technology Share-Holding Co., Ltd.
Enrollment: 336
Locations: 34
Primary Endpoint: Proportion of patients with HBsAg negative.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.

Registry

clinicaltrials.gov

Start Date

December 28, 2021

End Date

December 30, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Kawin Technology Share-Holding Co., Ltd.

Responsible Party

Principal Investigator

Junqi Niu

Principal Investigator

The First Hospital of Jilin University

Eligibility Criteria

Inclusion Criteria

•Age between 18 and 65 years (including 18 and 60), no gender limit.
•BMI between 18 and 30 kg/m2 (including 18 and 30).
•For treatment naive patients: Did not receive standard anti-HBV treatment within 6 months prior to screening (Including interferon, NAs, and other anti-HBV drugs).
•For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs.
•HBsAg positive for at least 6 months and HBsAg between 10 and 1000 IU/mL (excluding 10 and 1000).
•HBsAb and HBeAg both are negative at screening.
•For treatment naive patients: HBV DNA \< 2×10\^3 IU/mL at screening.
•For NAs treated patients: HBV DNA \< 100 IU/mL at screening.
•For treatment naive patients: ALT ≤ 5ULN at screening.
•For NAs treated patients: ALT ≤ 2ULN at screening.

Exclusion Criteria

•For NAs treated patients: who have received standard treatment of interferon products within 6 months prior to screening.
•Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids.
•Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
•Evidence of liver compensation, including previous liver biopsy, imaging examination or clinical manifestations.
•Evidences of hepatic decompensation, including but not limited to serum total bilirubin\> 2 times the upper limit of normal (ULN); serum albumin \<35g/L; prothrombin activity (PTA) \<60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade.
•Evidence of hepatocellular carcinoma, or AFP\>\>50 ng/mL, or imaging examination revealed suspicious nodules in the liver.
•Liver diseases from other causes, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
•White blood cell count \<3×10\^9/L; neutrophil count\<1.5×10\^9/L; platelet count\<90×10\^9/L; hemoglobin below the lower limit of normal; serum creatine kinase (CK) \>3×ULN; blood phosphorus \<0.8 mmol/L; serum creatinine (SCr) \> 1×ULN.
•Diabetes mellitus or Poorly controlled Thyroid Diseases.
•Poorly controlled hypertension (systolic blood pressure\> 140mmHg, or diastolic blood pressure\> 90 mmHg) with hypertension -related retinal lesions.