A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
A Multi-center, Randomized, Blinded Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b Injection Combined With Tenofovir Disoproxil Fumarate Tablets in Patients With Chronic Hepatitis B
1 other identifier
interventional
475
1 country
33
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 alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.
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 2019
Typical duration for phase_3
33 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 4, 2019
CompletedFirst Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 15, 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 7, 2023
CompletedMarch 5, 2024
August 1, 2023
4 years
April 12, 2021
March 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with HBsAg negative.
24 weeks post treatment.
Secondary Outcomes (10)
Changes of HBsAg level from baseline.
up to 168 weeks.
Proportion of patients with HBsAg seroconversion.
up to 168 weeks.
Proportion of patients with HBeAg negative.
up to 168 weeks
Proportion of patients with HBeAg seroconversion.
up to 168 weeks.
Changes of HBeAg level from baseline.
up to 168 weeks.
- +5 more secondary outcomes
Study Arms (4)
Nucleot(s)ide-treated patients-Experimental Group 1
EXPERIMENTALNucleot(s)ide-treated patients-Experimental Group 2
EXPERIMENTALNucleot(s)ide-treated patients-Control Group
ACTIVE COMPARATORTreatment Naive Group
OTHERInterventions
Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment.
Eligibility Criteria
You may qualify if:
- Understand and sign the informed consent form voluntarily.
- Age between 18 and 65 years (including 18 and 65), no gender limit.
- HBsAg-positive for at least 6 months or other evidence supporting chronic infection with hepatitis B virus.
- HBsAg positive at screening.
- For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs. Simultaneously, the patients should have achieved the following criteria: HBsAg\<1500IU/mL, HBV DNA\<100IU/ml, HBeAg\<10s/co at screening.
- For treatment naive patients: HBV DNA≥1×10\^4IU/ml, and 2×ULN (upper limit of normal) ≤ALT≤10×ULN at screening.
- Pregnancy test of female of childbearing must be negative within 24 hours before the first medication, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
You may not qualify if:
- Women who are pregnant, breastfeeding or planning to pregnant during the study period.
- Subjects with neuropsychiatric diseases and/or neuropsychiatric family history, especially depression, anxiety, or mania schizophrenia.
- Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
- Chronic hepatitis other than hepatitis B, e.g. alcoholic hepatitis, drugs-induced hepatitis, or autoimmune hepatitis, etc.
- Moderate to severe steatohepatitis.
- Evidence of acute severe hepatitis, e.g. ALT\>10×ULN, significantly increasing in ALT accompanied by elevated bilirubin, etc.
- Evidence of liver decompensation, e.g. total bilirubin higher than 2×ULN, albumin lower than 35g/L, prothrombin time is 3 seconds longer than the upper limit of normal, prothrombin activity lower than 60%, or history of decompensated liver cirrhosis, etc.
- Evidence of hepatocellular carcinoma, or AFP\>1×ULN.
- Significant kidney diseases, including acute nephritis, chronic nephritis, renal insufficiency, nephrotic syndrome, etc. or serum creatinine higher than upper limit of normal.
- Neutrophil count less than 1.5×10\^9/L, or platelet count less than 90×10\^9/L at screening.
- Serum phosphorus lower than 0.8mmol/L.
- Antinuclear antibody (ANA) exceeds 1:100.
- Autoimmune disease, including psoriasis, systemic lupus erythematosus, etc.
- Subjects with endocrine system disease, including thyroid, Diabetes mellitus, etc.
- Poorly controlled hypertension (blood pressure ≥140/90 mmHg).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Amoytop Biotech Co., Ltd.lead
- Peking University First Hospitalcollaborator
Study Sites (33)
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
The fifth medical center of PLA General Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital Central South University
Changsha, China
Public Health Clinical Center of Chengdu
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Mengchao Hepatobiliary Hosipital of Fujian Medical University
Fuzhou, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
The Third Affiliated Hospital,SUN YAT-SEN University
Guangzhou, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Nanjing Drum Tower Hospital/The First Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Huashan Hospital affiliated to Fudan University
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
The Sixth People's Hospital of Shenyang
Shenyang, China
Peiking University Shenzhen Hospital
Shenzhen, China
The Third People's Hospital of shenzhen
Shenzhen, China
The First Hospital of Shanxi Medical University
Taiyuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China
Tianjin Third Central Hospital
Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region
Ürümqi, China
Tongji Hospital/Tongji Medical College Huazhong University of Science & Technology
Wuhan, China
Tangdu Hospital
Xi'an, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, China
Yanbian University Hospital/Yanbian Hospital
Yanbian, China
Henan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guiqiang Wang, Ph.D
Peking University First Hospital
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
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 15, 2021
Study Start
December 4, 2019
Primary Completion
November 30, 2023
Study Completion
December 7, 2023
Last Updated
March 5, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share