Trial · NCT01598831
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
NCT01598831, Phase 3, Completed, Asahi Kasei Pharma America Corporation; results first posted 2020-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy. Trials, record NCT01598831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01598831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
- NCT number
- NCT01598831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 816 participants, actual
- Lead sponsor
- Asahi Kasei Pharma America Corporation
- Conditions
- Severe Sepsis, Coagulopathy
- Interventions
- ART-123, Placebo
- First posted
- 2012-05-15
- Last updated
- 2020-04-21
- Results first posted
- 2020-04-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With 28-Day All-cause Mortality | 28 days | 28-Day All-cause Mortality |
| Primary | Number of Participants With On-Treatment Serious Major Bleeding Events | Through Study Day 28 | On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.) |
| Secondary | Follow up All-cause Mortality at 3 Months | 3 months | Follow up all-cause mortality at 3 months |
| Secondary | Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction | 28 days | Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days. |
| Secondary | Number of Participants With Anti-drug Antibodies | 18 months | Presence of Anti-drug antibodies up to 18 months |
Source ClinicalTrials.gov
Outcomes6
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 28-Day All-cause Mortality | 28 days | Full Analysis Set - All randomized and dosed subjects. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With On-Treatment Serious Major Bleeding Events | Through Study Day 28 | Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Follow up All-cause Mortality at 3 Months | 3 months | Full Analysis Set - All randomized and dosed subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction | 28 days | Full Analysis Set - All randomized and dosed subjects. | Days | MEAN |
| SECONDARY | Number of Participants With Anti-drug Antibodies | 18 months | Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group) | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Day 28 Mortality in Subjects With INR > 1.4 at Baseline and PLT > 30K at Baseline | Day 28 | Full Analysis Set - All randomized and dosed subjects. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results 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 28-Day All-cause Mortality | ART-123 | 106 | Participants | ||
| Number of Participants With 28-Day All-cause Mortality | Placebo | 119 | Participants | ||
| Number of Participants With On-Treatment Serious Major Bleeding Events | ART-123 | 23 | Participants | ||
| Number of Participants With On-Treatment Serious Major Bleeding Events | Placebo | 16 | Participants | ||
| Follow up All-cause Mortality at 3 Months | ART-123 | 126 | Participants | ||
| Follow up All-cause Mortality at 3 Months | Placebo | 136 | Participants | ||
| Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction | ART-123 | Shock-free and alive | 17.6 | Standard Deviation 10.50 | Days |
| Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction | Placebo | Shock-free and alive | 17.6 | Standard Deviation 10.56 | Days |
| Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction | ART-123 | Ventilation-free and alive | 15.8 | Standard Deviation 11.75 | Days |
| Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction | Placebo | Ventilation-free and alive | 14.5 | Standard Deviation 11.90 | Days |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ART-123 | 402 | |
| Overall Study | STARTED | Placebo | 414 | |
| Overall Study | Received at Least 1 Dose Study Treatment | ART-123 | 395 | |
| Overall Study | Received at Least 1 Dose Study Treatment | Placebo | 405 | |
| Overall Study | COMPLETED | ART-123 | 283 | |
| Overall Study | COMPLETED | Placebo | 278 | |
| Overall Study | NOT COMPLETED | ART-123 | 119 | |
| Overall Study | NOT COMPLETED | Placebo | 136 |
Source ClinicalTrials.gov
Adverse events486
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 | Anaemia | Blood and lymphatic system disorders | ART-123 | 99 | 396 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 78 | 404 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | ART-123 | 40 | 396 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 51 | 404 | |
| other | Atrial fibrillation | Cardiac disorders | ART-123 | 51 | 396 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 52 | 404 | |
| other | Constipation | Gastrointestinal disorders | ART-123 | 37 | 396 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 37 | 404 | |
| other | Diarrhoea | Gastrointestinal disorders | ART-123 | 31 | 396 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 36 | 404 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ART-123 | 141 | 395 |
| Total, all-cause mortality | Placebo | 148 | 405 |
| Total, other adverse events | ART-123 | 271 | 396 |
| Total, other adverse events | Placebo | 264 | 404 |
| Total, serious adverse events | ART-123 | 206 | 396 |
| Total, serious adverse events | Placebo | 202 | 404 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ART-123 vs Placebo: Number of Participants With Anti-drug Antibodies | Trial comparisons |
| ART-123 vs Placebo: Follow up All-cause Mortality at 3 Months | Trial comparisons |
| ART-123 vs Placebo: Day 28 Mortality in Subjects With INR > 1.4 at Baseline and PLT > 30K at Baseline | Trial comparisons |
| ART-123 vs Placebo: Number of Participants With On-Treatment Serious Major Bleeding Events | Trial comparisons |
| ART-123 vs Placebo: deaths from any cause | Trial comparisons |
| ART-123 vs Placebo: Number of Participants With 28-Day All-cause Mortality | Trial comparisons |
| ART-123 vs Placebo: serious adverse events | Trial comparisons |
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/NCT01598831
GET https://conductscience.org/api/trials/v1/NCT01598831/events?page=2