NCT05490836Completed
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
Peginterferon Alfa-2b Combined With Tenofovir Alafenamide Improves the Functional Cure Rate in Patients With HBeAg Negative Chronic Hepatitis B: an Open-labeled, Multicenter, Randomized and Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 210 (actual)
- First submitted
- 3 Aug 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 1 May 2026
- Lead sponsor
- Huashan Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT05490836
What you commit to
- Study type: Interventional
- Participants enrolled: 210
- From 1 Sept 2022 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcoholism or drug abuse within one year prior to the screening.
- Suspected hepatocellular carcinoma in B-ultrasound at screening; or fetoprotein alpha was greater than 100ng/ml, or cannot remain stable within 3 months before screening.
- Accepted organ transplantation previously.
Other illness
- 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.
- Liver disease caused by other reasons (eg. autoimmune liver disease, alcoholic liver disease, nonalcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.).
- 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 Hamilton Depression Scale score ≥ 7 points.
- Have a history of endocrine system or autoimmune diseases, such as thyroid disease, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, psoriasis, etc.
- Chronic diseases requiring long-term treatment, such as uncontrolled hypertension, diabetes, chronic obstructive pulmonary disease, etc.
- Malignant tumor.
Lab values
- 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.
Other
- Cirrhosis or Child-Pugh score of 7 or above.
- Pregnant or lactating women.
- Other reasons that the investigator considers unsuitable for inclusion.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.