Trial · NCT02577029
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
NCT02577029, Phase 2, Terminated, Arrowhead Pharmaceuticals; results first posted 2019-04-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV). Trials, record NCT02577029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02577029
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
- NCT number
- NCT02577029
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Arrowhead Pharmaceuticals
- Conditions
- Hepatitis B, Hepatitis D
- Interventions
- ARC-520, entecavir, pegylated interferon alpha 2a, tenofovir disoproxil, antihistamine
- First posted
- 2015-10-15
- Last updated
- 2026-01-13
- Other registries' IDs
- eudract:2015-005499-46
- Results first posted
- 2019-04-12
- Limitations and caveats
The ARC-520 Injection development program was terminated early for regulatory and business reasons secondary to findings occurring in a non-clinical toxicology study. Program termination was not due to safety findings in humans.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline | Baseline, Week 60 | The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up | The Principal Investigator (or medically qualified designee) will use clinical judgment to determine the relationship. An adverse event (AE) was considered "possibly related" when there is a reasonable possibility that the incident, experience, or outcome may have been caused by the product under investigation. An AE was considered "probably related" when there are facts, evidence, or arguments to suggest that the event is related to the product under investigation. Only AEs that occurred post-dose were considered treatment-emergent. Clinically significant abnormal laboratory findings or other abnormal assessments that are detected during the study or are present at baseline and significantly worsen following the start of the study will be reported as AEs. |
| Secondary | Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time | Weeks 52, 60, 72 and 96 | The qualitative HBsAg assay gives a binary result, positive or negative. |
| Secondary | Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time | Weeks 52, 60, 72 and 96 | |
| Secondary | Time to HBsAg Loss | Baseline through Week 96 | |
| Secondary | Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion | Baseline through Week 96 | |
| Secondary | Percentage of Participants With Anti-HBs Seroconversion Over Time | Weeks 52, 60, 72 and 96 | |
| Secondary | Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time | Weeks 52, 60, 72 and 96 | |
| Secondary | Percentage of Participants With Resistance to ARC-520 Injection by Week 52 | Week 52 | Resistance is defined as \> 1.0 log IU/mL quantitative HBsAg (qHBsAg) increase from nadir, confirmed by repeat test. |
| Secondary | Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60 | Baseline, Week 60 | Resistance is defined as \> 1.0 log IU/mL increase in HBV DNA from nadir, confirmed by repeat test. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline | Baseline, Week 60 | The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed. | ||
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time | Weeks 52, 60, 72 and 96 | The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed. | ||
| SECONDARY | Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time | Weeks 52, 60, 72 and 96 | The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed. | ||
| SECONDARY | Time to HBsAg Loss | Baseline through Week 96 | This analysis was not done since no events of HBsAg loss were observed to to Week 36. (No participant reached Week 96 of treatment due to study termination). | ||
| SECONDARY | Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion | Baseline through Week 96 | This analysis was not done since no events of HBsAg loss were observed to to Week 36. (No participant reached Week 96 of treatment due to study termination). | ||
| SECONDARY | Percentage of Participants With Anti-HBs Seroconversion Over Time | Weeks 52, 60, 72 and 96 | The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed. | ||
| SECONDARY | Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time | Weeks 52, 60, 72 and 96 | The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed. | ||
| SECONDARY | Percentage of Participants With Resistance to ARC-520 Injection by Week 52 | Week 52 | The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed. | ||
| SECONDARY | Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60 | Baseline, Week 60 | The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group16
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 Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 1 | Related TEAE | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 2 | Related TEAE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 3 | Related TEAE | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 4 | Related TEAE | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 5 | Related TEAE | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 6 | Related TEAE | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 7 | Related TEAE | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 8 | Related TEAE | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 1 | Related Serious TEAE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment | Cohort 2 | Related Serious TEAE | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 10 | |
| Overall Study | STARTED | Cohort 2 | 2 | |
| Overall Study | STARTED | Cohort 3 | 7 | |
| Overall Study | STARTED | Cohort 4 | 12 | |
| Overall Study | STARTED | Cohort 5 | 11 | |
| Overall Study | STARTED | Cohort 6 | 13 | |
| Overall Study | STARTED | Cohort 7 | 12 | |
| Overall Study | STARTED | Cohort 8 | 12 | |
| Overall Study | COMPLETED | Cohort 1 | 0 | |
| Overall Study | COMPLETED | Cohort 2 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events648
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 | Leukopenia | Blood and lymphatic system disorders | Cohort 1 | 0 | 10 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 2 | 0 | 2 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 3 | 0 | 7 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 4 | 0 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 5 | 0 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 6 | 0 | 13 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 7 | 4 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 8 | 0 | 12 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1 | 0 | 10 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2 | 0 | 2 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, all-cause mortality | Cohort 2 | ||
| Total, all-cause mortality | Cohort 3 | ||
| Total, all-cause mortality | Cohort 4 | ||
| Total, all-cause mortality | Cohort 5 | ||
| Total, all-cause mortality | Cohort 6 | ||
| Total, all-cause mortality | Cohort 7 | ||
| Total, all-cause mortality | Cohort 8 | ||
| Total, other adverse events | Cohort 1 | 5 | 10 |
| Total, other adverse events | Cohort 2 | 0 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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/NCT02577029
GET https://conductscience.org/api/trials/v1/NCT02577029/flow?page=2