CompletedNot Applicable

Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy

China33 participantsStarted 2017-12-01

Plain-language summary

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period

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: * age 18 to 65 years; * HBsAg seropositive status for more than 6 months prior to enrollment; * never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment; * Serum HBsAg ≤1500 IU/mL; * HBeAg negative with or without HBeAb positive; * Serum HBV DNA ≤2000IU/ml IU/mL; * normal ALT levels; * normal white blood cell and platelet counts; * abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites. Exclusion Criteria: * Participants with other hepatotropic viruses or human immunodeficiency virus co-infection * other chronic non-viral liver diseases or decompensated liver diseases * tumours * drug abuse * severe psychiatric disease * uncontrolled thyroid disease or diabetes * pregnancy or lactation

What they're measuring

HBsAg clearance at the end of 68 weeks of treatment

Timeframe: 68 weeks of treatment

Trial details

NCT IDNCT05451420

SponsorHenan Provincial People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30