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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04846491
Other study ID # TB1901IFN
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 4, 2019
Est. completion date December 7, 2023

Study information

Verified date August 2023
Source Xiamen Amoytop Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 475
Est. completion date December 7, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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). - 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
China 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 Urumqi
China Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region Urumqi
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

Sponsors (2)

Lead Sponsor Collaborator
Xiamen Amoytop Biotech Co., Ltd. Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with HBsAg negative. 24 weeks post treatment.
Secondary Changes of HBsAg level from baseline. up to 168 weeks.
Secondary Proportion of patients with HBsAg seroconversion. up to 168 weeks.
Secondary Proportion of patients with HBeAg negative. up to 168 weeks
Secondary Proportion of patients with HBeAg seroconversion. up to 168 weeks.
Secondary Changes of HBeAg level from baseline. up to 168 weeks.
Secondary Proportion of patients with HBV DNA undetectable. up to 168 weeks.
Secondary Changes of HBV DNA level from baseline. up to 168 weeks.
Secondary Proportion of patients with ALT normalization. up to 168 weeks.
Secondary Proportion of patients with liver fibrosis. up to 168 weeks.
Secondary Proportion of patients with liver cirrhosis. up to 168 weeks.
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