A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
NCT ID: NCT04846491
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
475 participants
INTERVENTIONAL
2019-12-04
2023-12-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
NCT06707922
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
NCT03181113
Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection
NCT06544551
Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection
NCT02973646
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
NCT02366247
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nucleot(s)ide-treated patients-Experimental Group 1
Peginterferon alfa-2b injection
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.
Nucleot(s)ide-treated patients-Experimental Group 2
Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (low 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.
Nucleot(s)ide-treated patients-Control Group
TDF
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.
Treatment Naive Group
Peginterferon alfa-2b injection
Peginterferon alfa-2b injection 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon alfa-2b injection
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.
Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (low 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.
TDF
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.
Peginterferon alfa-2b injection
Peginterferon alfa-2b injection 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
* Severe retinopathy or any other severe diseases in the eyes.
* Subject who had ever received organ transplants or are planning to receive organ transplant.
* For NAs-treated patients: who have received standard treatment of interferon products within 6 months prior to screening .
* For treatment naive patients: who have ever received standard treatment of interferon products, or who have ever received NAs within 6 months prior to screening.
* Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.
* Subjects who participated in any other interventional trials within 3 months prior to screening, or with any other conditions which in the opinion of the investigator precluding enrollment from the study.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University First Hospital
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guiqiang Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TB1901IFN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.