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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
475
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 (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.
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.
Proportion of patients with HBsAg negative.
Time frame: 24 weeks post treatment.
Changes of HBsAg level from baseline.
Time frame: up to 168 weeks.
Proportion of patients with HBsAg seroconversion.
Time frame: up to 168 weeks.
Proportion of patients with HBeAg negative.
Time frame: up to 168 weeks
Proportion of patients with HBeAg seroconversion.
Time frame: up to 168 weeks.
Changes of HBeAg level from baseline.
Time frame: up to 168 weeks.
Proportion of patients with HBV DNA undetectable.
Time frame: up to 168 weeks.
Changes of HBV DNA level from baseline.
Time frame: up to 168 weeks.
Proportion of patients with ALT normalization.
Time frame: up to 168 weeks.
Proportion of patients with liver fibrosis.
Time frame: up to 168 weeks.
Proportion of patients with liver cirrhosis.
Time frame: up to 168 weeks.
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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.
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
...and 23 more locations