Clinical Study of YKYY013 Injection in HBeAg-negative Chronic Hepatitis B Virus-infected Patients Treated With Nucleos(t)Ide Analogues
NCT07933627, Phase 2, Not yet recruiting, Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Study of YKYY013 Injection in HBeAg-negative Chronic Hepatitis B Virus-infected Patients Treated With Nucleos(t)Ide Analogues | ClinicalTrials.gov |
| NCT number | NCT07933627 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. | ClinicalTrials.gov |
| Conditions | HBV (Hepatitis B Virus) | ClinicalTrials.gov |
| Interventions | YKYY013, YKYY013 Placebo | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The proportion (percent) of participants who achieved serum HBsAg < LLOQ (0.05 IU/mL) and HBVDNA < LLOQ at the 24th week | Week 24 | ClinicalTrials.gov | |
| Secondary | The proportion (percent) of trial participants who maintained sustained efficacy during the 24-week period after discontinuation of YKYY013 (the NA monotherapy period, up to W72) after completing the YKYY013 treatment course. | Week 72 | ClinicalTrials.gov | |
| Secondary | The proportion (percent) of participants who achieved serum HBsAg < LLOQ (0.05 IU/mL) and HBV DNA < LLOQ at the end of YKYY013 treatment. | Week 48 | ClinicalTrials.gov | |
| Secondary | The proportion (percent) of trial participants who met the NA drug discontinuation criteria and stopped all chronic hepatitis B treatments (YKYY013 and NA drugs) and maintained sustained efficacy during a 24-week period. | Week 72，Week 96 | ClinicalTrials.gov | |
| Secondary | The proportion (percent) of trial participants who met the discontinuation criteria for NA treatment at the 72nd week | Week 72 | ClinicalTrials.gov | |
| Secondary | Compared to the baseline level, the percentage (percent) of participants in the HBsAg test at different levels was reduced (e.g., ≥0.5, ≥1, ≥1.5, ≥2.0, ≥3 log10 IU/mL); | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The detection values (IU/mL) of HBsAg; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The maximum reductions (IU/mL) of HBsAg from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The relative changes (IU/mL)of HBsAg from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The detection values (copies/ml) of HBV RNA; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The maximum reductions (copies/ml) of HBV RNA from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The relative changes (copies/ml) of HBV RNA from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The detection values (U/mL) of HBcrAg; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The maximum reductions (U/mL) of HBcrAg from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The relative changes (U/mL) of HBcrAg from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The detection values (IU/mL) of HBV DNA; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The maximum reductions (IU/mL) of HBV DNA from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The relative changes (IU/mL) of HBV DNA from the baseline; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The number and percentage (percent) of trial participants whose HBsAg and/or HBV DNA levels have dropped below the quantitative limit; | From the first day to the 96th week | ClinicalTrials.gov | |
| Secondary | The number and percentage (percent) of trial participants whose highly sensitive HBsAg (LLOQ ≤ 0.005 IU/mL) decreased below the quantitative limit; | From the first day to the 96th week | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)