Trial · NCT02222545
Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
NCT02222545, Phase 2, Completed, Omeros Corporation; results first posted 2024-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies. Trials, record NCT02222545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02222545
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
- NCT number
- NCT02222545
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Omeros Corporation
- Conditions
- Thrombotic Microangiopathies
- Interventions
- OMS721
- First posted
- 2014-08-21
- Last updated
- 2024-08-28
- Other registries' IDs
- eudract:2014-001032-11
- Results first posted
- 2024-08-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | Day 1 to 37 days after end of treatment, approximately up to 31 weeks. | Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs. |
| Primary | Number of Participants With HSCT-TMA Who Respond to OMS721 | Day 1 to up to 2 years following the first dose of OMS721 | Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status |
| Secondary | Participants With HSCT-TMA Treated With OMS721: 100-day Survival | Study Day of HSCT-TMA diagnosis to 100 days later | Number of participants alive from the date of TMA diagnosis |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Overall Survival | Study Day of HSCT-TMA diagnosis to up to 2 years following first dose of OMS721 | Survival days from the day of TMA diagnosis |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Duration of Response | Study Day 1 to up to 2 years following first dose of OMS721 | Number of days from the first response date to the first relapse date |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion | Study Day -14 to 4 weeks following the last platelet transfusion | Number of participants with absence of platelet transfusions |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion | Study Day -14 to 4 weeks following the last RBC transfusion | Number of participants with absence of RBC transfusions |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Platelet Count | Study Day 1 to Day 97, approximately 13 weeks | Changes from baseline in Platelet count |
| Secondary | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | Pre-dose and up to 204 days post-dose | PK parameters including clearance rate |
| Secondary | Participants With HSCT-TMA (ADA) | Pre-dose and up to 204 days post-dose | Presence of ADA response. Immunogenicity of multiple-dose administration of OMS721 in subjects with TMA |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | Day 1 to 37 days after end of treatment, approximately up to 31 weeks. | 28 participants entered the study with a diagnosis of HSCT-TMA; all participants were in the High Dose Arm | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With HSCT-TMA Who Respond to OMS721 | Day 1 to up to 2 years following the first dose of OMS721 | Only subjects with HSCT-TMA were analyzed; 28 subjects with HSCT were in the Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: 100-day Survival | Study Day of HSCT-TMA diagnosis to 100 days later | Only participants with HSCT-TMA were analyzed; all 28 HSCT-TMA participants were in the OMS721 high dose arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Overall Survival | Study Day of HSCT-TMA diagnosis to up to 2 years following first dose of OMS721 | Only participants with HSCT-TMA were analyzed; all 28 HSCT-TMA participants were in the OMS721 high dose arm | days | MEDIAN |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Duration of Response | Study Day 1 to up to 2 years following first dose of OMS721 | Only participants with HSCT-TMA and responded to OMS721 were analyzed. | Days | MEDIAN |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion | Study Day -14 to 4 weeks following the last platelet transfusion | Only participants with HSCT-TMA who were receiving platelet transfusions were analyzed; all were in the OMS721 high dose arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion | Study Day -14 to 4 weeks following the last RBC transfusion | Only participants with HSCT-TMA who were receiving RBC transfusions were analyzed; all were in the OMS721 high dose arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Platelet Count | Study Day 1 to Day 97, approximately 13 weeks | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | 10^9 cells per liter | MEAN |
| SECONDARY | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | Pre-dose and up to 204 days post-dose | PK parameters were reported for all groups combined. | L/H | MEAN |
| SECONDARY | Participants With HSCT-TMA (ADA) | Pre-dose and up to 204 days post-dose | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | OMS721 Low Dose | 0 | Participants | ||
| Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | OMS721 Medium Dose | 0 | Participants | ||
| Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | OMS721 High Dose | 27 | Participants | ||
| Number of Participants With HSCT-TMA Who Respond to OMS721 | OMS721 Low Dose | 0 | Participants | ||
| Number of Participants With HSCT-TMA Who Respond to OMS721 | OMS721 Medium Dose | 0 | Participants | ||
| Number of Participants With HSCT-TMA Who Respond to OMS721 | OMS721 High Dose | 17 | Participants | ||
| Participants With HSCT-TMA Treated With OMS721: 100-day Survival | OMS721 Low Dose | 0 | Participants | ||
| Participants With HSCT-TMA Treated With OMS721: 100-day Survival | OMS721 Medium Dose | 0 | Participants | ||
| Participants With HSCT-TMA Treated With OMS721: 100-day Survival | OMS721 High Dose | 19 | Participants | ||
| Participants With HSCT-TMA Treated With OMS721: Overall Survival | OMS721 High Dose | 274 | 95% Confidence Interval 103 to NA | days |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OMS721 Low Dose | 3 | |
| Overall Study | STARTED | OMS721 Medium Dose | 3 | |
| Overall Study | STARTED | OMS721 High Dose | 52 | |
| Overall Study | COMPLETED | OMS721 Low Dose | 2 | |
| Overall Study | COMPLETED | OMS721 Medium Dose | 3 | |
| Overall Study | COMPLETED | OMS721 High Dose | 27 | |
| Overall Study | NOT COMPLETED | OMS721 Low Dose | 1 | |
| Overall Study | NOT COMPLETED | OMS721 Medium Dose | 0 | |
| Overall Study | NOT COMPLETED | OMS721 High Dose | 25 |
Source ClinicalTrials.gov
Adverse events234
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 | AE by System Organ | Infections and infestations | HSCT-TMA-001 High Dose (N=28) | 20 | 28 | |
| other | AE by System Organ | Infections and infestations | aHUS OMS721-TMA-001 Low Dose | 2 | 3 | |
| other | AE by System Organ | Infections and infestations | aHUS OMS721-TMA-001 Medium Dose | 0 | 2 | |
| other | AE by System Organ | Infections and infestations | aHUS OMS721-TMA-001 High Dose | 14 | 20 | |
| other | AE by System Organ | Infections and infestations | TTP OMS721-TMA-001 Medium Dose | 0 | 1 | |
| other | AE by System Organ | Infections and infestations | TTP OMS721-TMA-001 High Dose | 1 | 4 | |
| other | AE by System Organ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | HSCT-TMA-001 High Dose (N=28) | 3 | 28 | |
| other | AE by System Organ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | aHUS OMS721-TMA-001 Low Dose | 0 | 3 | |
| other | AE by System Organ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | aHUS OMS721-TMA-001 Medium Dose | 0 | 2 | |
| other | AE by System Organ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | aHUS OMS721-TMA-001 High Dose | 1 | 20 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HSCT-TMA-001 High Dose (N=28) | 16 | 28 |
| Total, all-cause mortality | aHUS OMS721-TMA-001 Low Dose | 0 | 3 |
| Total, all-cause mortality | aHUS OMS721-TMA-001 Medium Dose | 0 | 2 |
| Total, all-cause mortality | aHUS OMS721-TMA-001 High Dose | 3 | 20 |
| Total, all-cause mortality | TTP OMS721-TMA-001 Medium Dose | 0 | 1 |
| Total, all-cause mortality | TTP OMS721-TMA-001 High Dose | 0 | 4 |
| Total, other adverse events | HSCT-TMA-001 High Dose (N=28) | 27 | 28 |
| Total, other adverse events | aHUS OMS721-TMA-001 Low Dose | 2 | 3 |
| Total, other adverse events | aHUS OMS721-TMA-001 Medium Dose | 1 | 2 |
| Total, other adverse events | aHUS OMS721-TMA-001 High Dose | 19 | 20 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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 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.
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GET https://conductscience.org/api/trials/v1/NCT02222545/results?page=2