Trial · NCT02222545
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 | |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in LDH | Study Day 1 to Day 97, approximately 13 weeks | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | U/L | MEAN |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Creatine | Study Day 1 to Day 97, approximately 13 weeks | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | mg/dL | MEAN |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Haptoglobin | Study Day 1 to Day 97, approximately 13 weeks | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | mg/dL | MEAN |
| SECONDARY | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Hemoglobin | Study Day 1 to Day 97, approximately 13 weeks | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | g/dL | 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 | 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. | ug/mL | MEAN |
| SECONDARY | Participants With HSCT-TMA: Pharmacodynamics (PD) | Pre-dose and up to 204 days post-dose | PD was analyzed only in HSCT-TMA participants | Percentage | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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