Trial · NCT06425341
A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
NCT06425341, Phase 2, Recruiting, Fujian Shengdi Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B. Trials, record NCT06425341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06425341
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
- NCT number
- NCT06425341
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 369 participants, estimated
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Conditions
- Chronic Hepatitis B
- Interventions
HRS-5635 Injection, HRS-5635 Injection, HRS-5635 Injection, HRS-5635 Injection, HRS-5635 Injection (low dose) and Peg-IFN-α, HRS-5635 Injection (high dose) and Peg-IFN-α, Peg-IFN-α, HRS-5635 Injection with Peg-IFN-α, HRS-5635 Injection
- First posted
- 2024-05-22
- Last updated
- 2025-11-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12 | Week 12 | |
| Primary | PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 | Week 48 | |
| Primary | PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 | Week 48 | |
| Primary | PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 | Week 48 | |
| Secondary | Changes from baseline in mean log10 serum hepatitis B surface antigen levels | Pre-specified time points up to 72 weeks | |
| Secondary | Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen | Pre-specified time points up to 72 weeks | |
| Secondary | Proportion of subjects with serum hepatitis B surface antigen loss | Pre-specified time points up to 72 weeks | |
| Secondary | Proportion of subjects with serum hepatitis B surface antigen seroconversion | Pre-specified time points up to 72 weeks | |
| Secondary | Proportion of subjects with hepatitis B e-antigen loss | Pre-specified time points up to 72 weeks | |
| Secondary | Proportion of subjects with serum hepatitis B e-antigen seroconversion | Pre-specified time points up to 72 weeks |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06425341
GET https://conductscience.org/api/trials/v1/NCT06425341/registered