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A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

A Multi-center, Randomized, Blinded Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b Injection Combined With Tenofovir Disoproxil Fumarate Tablets in Patients With Chronic Hepatitis B

NCT04846491•Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+12 more criteria

Locations (33)

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

Key Dates

Start Date

December 4, 2019

Primary Completion Date

November 30, 2023

Completion Date

December 7, 2023

Last Updated

March 5, 2024

Enrollment

475

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

Peginterferon alfa-2b injection

DRUG

Peginterferon alfa-2b injection

DRUG

TDF

DRUG

Peginterferon alfa-2b injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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