Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
NCT Number: NCT06900166
All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC treatment can attempt to discontinue the drug. At the same time, the patient's HBsAg level will not be higher than 1000 IU/mL. The study will set up three groups, group A directly stopped nucleoside analogues, follow-up to 96 weeks; Group B received PegIFNα-2b monotherapy for 48 weeks, group C received PegIFNα-2b combined with NUC treatment for 48 weeks, group B and group C stopped all antiviral drugs after completing 48 weeks of treatment, and then followed up for 96 weeks, a total of 144 weeks of follow-up. This study aims to further optimize the design on the basis of previous clinical studies to observe whether sequential interferon or combined with NUC therapy can reduce the virological relapse rate of HBeAg-negative chronic hepatitis B patients with low HBsAg level after 96 weeks of discontinuation, and to observe the impact on the functional cure rate.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, 200040, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
180 μg/ 0.5 ml ,hypodermic injection once a week
180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug
Time frame: 96 weeks after stopping NAs
the cumulative virological relapse rate (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
Time frame: 72 weeks after stopping all antivirals
The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
Time frame: 72 weeks and 96 weeks after stopping all antivirals
Time frame: 96 weeks after stopping all antivirals
Time frame: 96 weeks after stopping all antivirals
Patients with virological relapse may be retreated according to the following criteria: 1) ALT >10×ULN, 2)ALT >5×ULN and total bilirubin >2 mg/dl, 3)ALT >3×ULN and HBV DNA >100,000 IU/ml, 4) ALT >ULN and HBV DNA >2,000 IU/ml for more than 3 months; 5) PT increases by more than 2s, while ALT >5×ULN.
Contact information is provided by the study sponsor or research team.
Huashan Hospital
Other
A Prospective, Open-Label, Randomized, Controlled, Multicenter Clinical Study of Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-Negative Chronic Hepatitis B Patients with Low-Level HBsAg
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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