Trial · NCT04781647
A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection
NCT04781647, Phase 2, Terminated, Assembly Biosciences; results first posted 2023-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection. Trials, record NCT04781647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04781647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection
- NCT number
- NCT04781647
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Assembly Biosciences
- Conditions
- Chronic Hepatitis B
- Interventions
- ABI-H0731, ETV, Peg-IFNα
- First posted
- 2021-03-04
- Last updated
- 2023-10-06
- Results first posted
- 2023-10-06
- Limitations and caveats
Study ABI-H0731-203 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. As a result, not all subjects completed Week 48 and some outcome measures were impacted.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | Up to 60 weeks | |
| Primary | Number of Participants With Premature Discontinuation of Treatment | Up to 60 weeks | |
| Primary | Number of Participants With a Laboratory Abnormality | Up to 60 weeks | |
| Secondary | Mean Change From Baseline in HBV pgRNA | Baseline and at pre-specified time points up to 60 weeks | |
| Secondary | Mean Change From Baseline HBV DNA | Baseline and at pre-specified time points up to 60 weeks | |
| Secondary | Mean Change From Baseline in HBeAg | Baseline and at pre-specified time points up to 60 weeks | |
| Secondary | Mean Change From Baseline in HBcrAg | Baseline and at pre-specified time points up to 60 weeks | |
| Secondary | Mean Change From Baseline in HBsAg | Baseline and at pre-specified time points up to 60 weeks | |
| Secondary | Number of Participants With Normalized Alanine Aminotransferase (ALT) | Baseline and at pre-specified time points up to 60 weeks | |
| Secondary | Plasma Concentration of ABI-H0731 | Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Adverse Event | Up to 60 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Premature Discontinuation of Treatment | Up to 60 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Laboratory Abnormality | Up to 60 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change From Baseline in HBV pgRNA | Baseline and at pre-specified time points up to 60 weeks | Due to early termination of the study, not all subjects reached Week 48. | log10 U/mL | MEAN |
| SECONDARY | Mean Change From Baseline HBV DNA | Baseline and at pre-specified time points up to 60 weeks | Due to early termination of the study, not all subjects reached Week 48. | log10 IU/mL | MEAN |
| SECONDARY | Mean Change From Baseline in HBeAg | Baseline and at pre-specified time points up to 60 weeks | Due to early termination of the study, not all subjects reached Week 48. | log10 IU/mL | MEAN |
| SECONDARY | Mean Change From Baseline in HBcrAg | Baseline and at pre-specified time points up to 60 weeks | Due to early termination of the study, not all subjects reached Week 48. | log10 kU/mL | MEAN |
| SECONDARY | Mean Change From Baseline in HBsAg | Baseline and at pre-specified time points up to 60 weeks | Due to early termination of the study, not all subjects reached Week 48. | log10 IU/mL | MEAN |
| SECONDARY | Number of Participants With Normalized Alanine Aminotransferase (ALT) | Baseline and at pre-specified time points up to 60 weeks | Due to early termination of the study, data were not collected or analyzed for secondary outcomes. | ||
| SECONDARY | Plasma Concentration of ABI-H0731 | Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24 | No ABI-H0731 PK data were collected from the ETV + Peg-IFNα group until Week 24 when they started receiving ABI-H0731. | ng/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group226
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Adverse Event | ABI-H0731 + ETV | 14 | Participants | ||
| Number of Participants With an Adverse Event | ABI-H0731 + ETV + Peg-IFNα | 17 | Participants | ||
| Number of Participants With an Adverse Event | ETV + Peg-IFNα | 17 | Participants | ||
| Number of Participants With Premature Discontinuation of Treatment | ABI-H0731 + ETV | 18 | Participants | ||
| Number of Participants With Premature Discontinuation of Treatment | ABI-H0731 + ETV + Peg-IFNα | 17 | Participants | ||
| Number of Participants With Premature Discontinuation of Treatment | ETV + Peg-IFNα | 11 | Participants | ||
| Number of Participants With a Laboratory Abnormality | ABI-H0731 + ETV | 19 | Participants | ||
| Number of Participants With a Laboratory Abnormality | ABI-H0731 + ETV + Peg-IFNα | 16 | Participants | ||
| Number of Participants With a Laboratory Abnormality | ETV + Peg-IFNα | 17 | Participants | ||
| Mean Change From Baseline in HBV pgRNA | ABI-H0731 + ETV | Week 1 | -1.3 | Standard Deviation .51 | log10 U/mL |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABI-H0731 + Entecavir (ETV) | 20 | |
| Overall Study | STARTED | ABI-H0731 + ETV + Pegylated-interferon Alpha (Peg-IFNα) | 17 | |
| Overall Study | STARTED | ETV + Peg-IFNα | 17 | |
| Overall Study | COMPLETED | ABI-H0731 + Entecavir (ETV) | 6 | |
| Overall Study | COMPLETED | ABI-H0731 + ETV + Pegylated-interferon Alpha (Peg-IFNα) | 5 | |
| Overall Study | COMPLETED | ETV + Peg-IFNα | 6 | |
| Overall Study | NOT COMPLETED | ABI-H0731 + Entecavir (ETV) | 14 | |
| Overall Study | NOT COMPLETED | ABI-H0731 + ETV + Pegylated-interferon Alpha (Peg-IFNα) | 12 | |
| Overall Study | NOT COMPLETED | ETV + Peg-IFNα | 11 |
Source ClinicalTrials.gov
Adverse events258
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 |
|---|---|---|---|---|---|---|
| other | Platelet Count Decreased | Investigations | ABI-H0731 + ETV | 1 | 20 | |
| other | Platelet Count Decreased | Investigations | ABI-H0731 + ETV + Peg-IFNα | 9 | 17 | |
| other | Platelet Count Decreased | Investigations | ETV + Peg-IFNα | 9 | 17 | |
| other | Pyrexia | General disorders | ABI-H0731 + ETV | 0 | 20 | |
| other | Pyrexia | General disorders | ABI-H0731 + ETV + Peg-IFNα | 11 | 17 | |
| other | Pyrexia | General disorders | ETV + Peg-IFNα | 8 | 17 | |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | ABI-H0731 + ETV | 3 | 20 | |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | ABI-H0731 + ETV + Peg-IFNα | 6 | 17 | |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | ETV + Peg-IFNα | 4 | 17 | |
| other | White Blood Cell Count Decreased | Investigations | ABI-H0731 + ETV | 0 | 20 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABI-H0731 + ETV | 0 | 20 |
| Total, all-cause mortality | ABI-H0731 + ETV + Peg-IFNα | 0 | 17 |
| Total, all-cause mortality | ETV + Peg-IFNα | 0 | 17 |
| Total, other adverse events | ABI-H0731 + ETV | 14 | 20 |
| Total, other adverse events | ABI-H0731 + ETV + Peg-IFNα | 17 | 17 |
| Total, other adverse events | ETV + Peg-IFNα | 17 | 17 |
| Total, serious adverse events | ABI-H0731 + ETV | 0 | 20 |
| Total, serious adverse events | ABI-H0731 + ETV + Peg-IFNα | 1 | 17 |
| Total, serious adverse events | ETV + Peg-IFNα | 0 | 17 |
Source ClinicalTrials.gov
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/NCT04781647
GET https://conductscience.org/api/trials/v1/NCT04781647/results?page=2