Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection
1 other identifier
interventional
336
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2021
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedFirst Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedAugust 9, 2024
August 1, 2024
1.9 years
July 30, 2024
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with HBsAg negative.
Percentage of Participants with HBsAg \<0.05 IU/mL
72 weeks
Study Arms (2)
Peginterferon Alfacon-2 treated patients
EXPERIMENTALPeginterferon Alfacon-2 placebo treated patients
PLACEBO COMPARATORInterventions
Peginterferon Alfacon-2 injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.
Peginterferon Alfacon-2 placebo injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Peking university Peoole's hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
The second xiangya hospital of central south university
Changsha, China
Xiangya Hospital Central South University
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
The Peoole's hospital of Chizhou
Chizhou, China
The First Affiliated Hospital of Army Medical University
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Mengchao hepatobiliary hospital of Fujian medical university
Fuzhou, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Heze Municipal Hospital
Heze, China
Shandong Public Health Clinical Center
Jinan, China
Hebei petro china central hospital
Langfang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Hospital of Nanjing
Nanjing, China
Pingxiang NO.2 People's Hospital
Pingxiang, China
Qingdao Municipal Hospital
Qingdao, China
The Peoole's hospital of Qingyuan
Qingyuan, China
The Sixth People's Hospital of Shenyang
Shenyang, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, China
The Third Hospital of Hebei Medical University
Shijiazhuang, China
The Second People's Hospital of Tianjin
Tianjin, China
Tianjin Third Central Hospital
Tianjin, China
Tongji medical college of Hust
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, China
The third affiliated hospital of Xingxiang medical university
Xingxiang, China
Yanbian University Hospital
Yanbian, China
Henan People's Hospital
Zhengzhou, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 9, 2024
Study Start
December 28, 2021
Primary Completion
November 30, 2023
Study Completion
December 30, 2023
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share