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Trial · NCT07069569

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryProportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.up to 72 weeks
SecondaryProportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .Up to 72 weeks
SecondaryDetection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.Up to 72 weeks
SecondaryProportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.Up to 48 weeks
SecondaryRelapse rate after discontinuation of NAs therapy.Up to 72 weeks
SecondaryChange from baseline in alanine aminotransferase (ALT) values and time to normalization of values.Up to 72 weeks
SecondaryRelapse time after discontinuation of NAs therapy.Up to 72 weeks
SecondaryPlasma concentrations of AHB-137.Up to 48 weeks
SecondarySerum concentrations of Peg-IFN.Up to 48 weeks.
SecondarySafety: Number and percentage of participants with detectable anti-drug antibodies (ADA).Up to 72 weeks
SecondarySafety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.Up to 72 weeks
This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.
SecondarySafety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.Up to 72 weeksExamination including laboratory examination, electrocardiogram (ECG) examination.
SecondarySafety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .Up to 72 weeks.
The CSSRS is a categorical, interviewer-rated instrument that screens for suicidal ideation (five items, 0-1 each) and suicidal behavior (six items, 0-1 each); the highest positive item defines the risk level rather than a total score. For ideation items 3-5 an additional 0-5 intensity rating can be recorded. Across all items the minimum value is 0 (absent) and the maximum is 1 (present); a score of 1 on any item indicates a worse outcome and triggers escalating clinical safeguards, with any behavior item being tantamount to a suicidal event.
SecondarySafety: Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.Up to 72 weeks
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
SecondarySafety: Monitoring the score changes of Self-Rating Depression Scale (SDS).Up to 72 weeks.
The SDS is a 20-item, 4-point Likert self-report scale that yields a raw sum of 20-80 points, conventionally converted to a standard score of 25-100 by multiplying the raw total by 1.25. Higher standard scores denote worse outcomes: \<50 normal, 50-59 mild, 60-69 moderate, and ≥70 severe depression, with ≥70 warranting specialist evaluation and suicide-risk assessment.
SecondaryDiscontinue all treatment for CHB for 24 weeks with HBV DNA<LLOQ and HBsAg<10IU/mL.Up to 72 weeks

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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