Clinical trial NCT06544551: Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection
Official title: Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B Virus Infection
Lead sponsor: Beijing Kawin Technology Share-Holding Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Liver stiffness measurement \<8.0 kPa at screening.
* Pregnancy test of female of childbearing must be negative at screening, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
* Understand and sign the informed consent form voluntarily.

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.
* Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
* Psychiatric and nervous system disorders, including history of psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
* Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias).
* Serious blood disorders (all kinds of anemia, hemophilia, etc.)
* Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
* Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
* Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
* Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
* Malignancies.
* Function organs transplant.
* Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs.
* Evidence of alcohol or drug abuse (average alcohol consumption male\> 40g / day, female\> 20g / day).
* Women who are pregnant or lactating or to be pregnant during the study period.
* Participated in other clinical trials 3 months prior to the screening.
* Unwilling to sign the informed consent and adhere to treatment requirements.
* Other conditions not suitable for study judged by investigators.

Primary outcomes:
measure: Proportion of patients with HBsAg negative.
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking university Peoole's hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: The second xiangya hospital of central south university
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chizhou
country: China
facility: The Peoole's hospital of Chizhou
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Fuzhou
country: China
facility: Mengchao hepatobiliary hospital of Fujian medical university
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Heze
country: China
facility: Heze Municipal Hospital
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
city: Langfang
country: China
facility: Hebei petro china central hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
city: Pingxiang
country: China
facility: Pingxiang NO.2 People's Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Qingyuan
country: China
facility: The Peoole's hospital of Qingyuan
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
city: Shijiazhuang
country: China
facility: Shijiazhuang Hospital of Traditional Chinese Medicine
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Tianjin
country: China
facility: The Second People's Hospital of Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
city: Wuhan
country: China
facility: Tongji medical college of Hust
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xian Jiaotong University
city: Xingxiang
country: China
facility: The third affiliated hospital of Xingxiang medical university
city: Yanbian
country: China
facility: Yanbian University Hospital
city: Zhengzhou
country: China
facility: Henan People's Hospital
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
Study officials:
References: