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Trial · NCT07553767

Registered outcomes50

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryConcentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg)Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA). Unit: IU/mL
PrimaryProportion of patients with HBsAg lossBaseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240Proportion of patients with HBsAg loss (HBsAg \< 0.05 IU/mL) determined by CMIA. Unit: % of patients
PrimaryProportion of patients with HBsAg seroconversionBaseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240Proportion of patients with HBsAg loss (HBsAg \< 0.05 IU/mL) and anti-HBs seropositivity (anti-HBs ≥ 10 mIU/mL) determined by CMIA. Unit: % of patients
SecondaryConcentration of HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid)Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240Serum HBV DNA viral load quantified by a TaqMan-based real-time quantitative polymerase chain reaction (qPCR) assay. Unit: IU/mL
SecondaryConcentration of Hepatitis B e Antigen (HBeAg)Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240Serum HBeAg concentration assessed by CMIA. Unit: S/CO
SecondaryComposition and diversity of intestinal microbiotaBaseline, Week 24, Week 48Intestinal microbiota analyzed by 16S rRNA gene high-throughput sequencing. Unit: Relative abundance (%) and alpha diversity index
SecondaryRecurrence-Free Survival (RFS)Years 1, 2, 3, 5Time to first hepatocellular carcinoma (HCC) recurrence or death from any cause, which is confirmed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). Unit: Months
SecondaryOverall survival (OS)Years 1, 2, 3, 5Time from enrollment to death from any cause, regardless of the cause of death. Unit: Months
SecondaryConcentration of Interleukin-2 (IL-2)Baseline, Week 24, Week 48Serum levels of IL-2 will be measured using cytometric bead array (CBA). Unit: pg/mL
SecondaryConcentration of Interleukin-4 (IL-4)Baseline, Week 24, Week 48Serum levels of IL-4 will be measured using cytometric bead array (CBA). Unit: pg/mL
SecondaryConcentration of Interleukin-6 (IL-6)Baseline, Week 24, Week 48Serum levels of IL-6 will be measured using cytometric bead array (CBA). Unit: pg/mL
SecondaryConcentration of Interleukin-10 (IL-10)Baseline, Week 24, Week 48Serum levels of IL-10 will be measured using cytometric bead array (CBA). Unit: pg/mL
SecondaryConcentration of Tumor Necrosis Factor-α (TNF-α)Baseline, Week 24, Week 48Serum levels of TNF-α will be measured using cytometric bead array (CBA). Unit: pg/mL
SecondaryConcentration of Interferon-γ (IFN-γ)Baseline, Week 24, Week 48Serum levels of IFN-γ will be measured using cytometric bead array (CBA). Unit: pg/mL
OtherThe Levels of Thyroid Stimulating Hormone (TSH)Baseline, Weeks 12, 24, 36, 48TSH measured by chemiluminescent immunoassay (CLIA). Unit: mIU/L
OtherThe Levels of Free Triiodothyronine (FT3)Baseline, Weeks 12, 24, 36, 48FT3 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L
OtherThe Levels of Free Thyroxine (FT4)Baseline, Weeks 12, 24, 36, 48FT4 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L
OtherThe Levels of Thyroglobulin Antibody (TgAb)Baseline, Weeks 12, 24, 36, 48TgAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL
OtherThe Levels of Thyroid Peroxidase Antibody (TPOAb)Baseline, Weeks 12, 24, 36, 48TPOAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL
OtherConcentration of Alpha-fetoprotein (AFP)Baseline, Weeks 12, 24, 36, 48, 96, 144, 192AFP measured by CLIA. Unit: ng/mL

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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