Trial · NCT05855083
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
NCT05855083, Phase 2, Recruiting, Omeros Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA. Trials, record NCT05855083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05855083
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
- NCT number
- NCT05855083
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Omeros Corporation
- Conditions
- Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation
- Interventions
- Biological: narsoplimab
- First posted
- 2023-05-11
- Last updated
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 100-day survival rate following high-risk HSCT-TMA diagnosis. | 100 days | Percentage of patients alive at 100 days following the diagnosis of high-risk HSCT-TMA |
| Secondary | Number of participants with treatment-emergent adverse events assessed by CTCAE v5.0 | 52 weeks | Number and percentage of patients with treatment-emergent adverse events will be summarized by MedDRA system organ class and preferred term |
| Secondary | Percentage of patients meeting protocol definition of clinical response | 52 weeks | A responder is defined as a patient with HSCT-TMA who demonstrates improvement in laboratory TMA markers (platelet count and LDH) and clinical benefit (either improvement in organ function or reduction in transfusion burden) |
| Secondary | 52 week survival rate following high-risk HSCT-TMA diagnosis | 52 weeks | Percentage of patients alive at 52 weeks following the diagnosis of high-risk HSCT-TMA |
| Secondary | Overall survival following the diagnosis of high-risk HSCT-TMA | 52 weeks | Median overall survival (days) following the diagnosis of high-risk HSCT-TMA by Kaplan-Meier estimate |
| Secondary | Pharmacokinetics (PK) of multiple-dose administration of OMS721 | 52 weeks | PK parameters including maximum concentration and minimum (trough) concentration |
| Secondary | Presence of anti-drug antibody (ADA) | 52 weeks | Number and percentage of patient with at least one ADA positive sample |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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/NCT05855083
GET https://conductscience.org/api/trials/v1/NCT05855083/registered