Trial · NCT02222545
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in LDH | Study Day 1 to Day 97, approximately 13 weeks | Changes from baseline in LDH |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Creatine | Study Day 1 to Day 97, approximately 13 weeks | Changes from baseline in Creatine |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Haptoglobin | Study Day 1 to Day 97, approximately 13 weeks | Changes from baseline in Haptoglobin |
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Hemoglobin | Study Day 1 to Day 97, approximately 13 weeks | Changes from baseline in Hemoglobin |
| Secondary | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | Pre-dose and up to 204 days post-dose | PK parameters Apparent volume of the central compartment (V1) |
| Secondary | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | Pre-dose and up to 204 days post-dose | PK parameters Concentration of OMS721 that achieves half maximum elimination rate (KM) (ug/mL) |
| Secondary | Participants With HSCT-TMA: Pharmacodynamics (PD) | Pre-dose and up to 204 days post-dose | PD measure is expressed as percentage inhibition of C4d to assess ex-vivo lectin pathway activation |
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.
For software
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