Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients (NCT05490836) | Clinical Trial Compass
UnknownNot Applicable
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
200 participantsStarted 2022-09
Plain-language summary
The study is aimed to explore the safety and efficacy of the pulse usage , comparing to continuous usage, of Peginterferon alfa-2b Injection (PEG IFN α-2b) Combined With tenofovir alafenamide (TAF) in treatment of naive chronic hepatitis B patients with HBeAg negative.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Aged between 18 and 65,included.
* HBsAg positive, HBeAg negative, anti HBE antibody positive, HBV-DNA ≥ 2x10\^3 IU/ml, ALT is continuously or repeatedly abnormal, or there is definite inflammation, necrosis and / or fibrosis (≥ G2/S2) confirmed in liver biopsy.
* Received no antiviral treatment previously.
* pregnancy test of Female subjects of childbearing must be negative before the enrollment, and all potential subjects must agree to take effective contraceptive measures during the treatment period and within half a year after the end of the treatment.
* Understand and sign the informed consent voluntarily.
Exclusion criteria:
* Known allergy to interferon, nucleos(t)ide drugs, or any ingredient of the drug.
* Currently co-infection with HAV, HCV, HDV, HEV, HIV, or any other virus.
* Cirrhosis or Child-Pugh score of 7 or above.
* Liver disease caused by other reasons (eg. autoimmune liver disease, alcoholic liver disease, nonalcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.).
* Pregnant or lactating women.
* Alcoholism or drug abuse within one year prior to the screening.
* Neutrophil count\<1.5×10\^9/L, hemoglobin\<100g/L, or platelet count\<80×10\^9/L.
* Serum creatinine was higher than the upper limit of normal at screening.
* History of serious disease in heart, brain, kidney, retina, muscle, or other major organ and systems.
* Have a history of mental illness or family history of mental illness, or Ham…