Trial · NCT07069569
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion 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 | |
| Secondary | Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ . | Up to 72 weeks | |
| Secondary | Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. | Up to 72 weeks | |
| Secondary | Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period. | Up to 48 weeks | |
| Secondary | Relapse rate after discontinuation of NAs therapy. | Up to 72 weeks | |
| Secondary | Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values. | Up to 72 weeks | |
| Secondary | Relapse time after discontinuation of NAs therapy. | Up to 72 weeks | |
| Secondary | Plasma concentrations of AHB-137. | Up to 48 weeks | |
| Secondary | Serum concentrations of Peg-IFN. | Up to 48 weeks. | |
| Secondary | Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA). | Up to 72 weeks | |
| Secondary | Safety: 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. |
| Secondary | Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. | Up to 72 weeks | Examination including laboratory examination, electrocardiogram (ECG) examination. |
| Secondary | Safety: 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. |
| Secondary | Safety: 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. |
| Secondary | Safety: 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. |
| Secondary | Discontinue 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.
For software
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