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Monoclonal Antibodies

Narsoplimab for Post-Transplant TMA

Phase 2
Recruiting
Research Sponsored by Omeros Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights

Study Summary

This trial studies how safe and effective a drug is for children who had a blood cell transplant and then had blood clots in tiny blood vessels.

Who is the study for?
This trial is for pediatric patients under 18 who've had a bone marrow transplant and are now facing a complication called TMA. They should have certain lab markers like elevated C5b-9, signs of hemolysis, or risk of severe GVHD. Girls able to have children must use effective birth control. Consent from parents/guardians and patient assent where applicable is required.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of narsoplimab in treating TMA after stem cell transplants in kids. It aims to see if this biological treatment can help manage symptoms associated with high-risk TMA conditions following transplantation.See study design
What are the potential side effects?
While specific side effects for narsoplimab aren't listed here, similar treatments may cause reactions at the infusion site, changes in blood pressure or heart rate, allergic responses, or interfere with liver function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
100-day survival rate following high-risk HSCT-TMA diagnosis.
Secondary outcome measures
52 week survival rate following high-risk HSCT-TMA diagnosis
Number of participants with treatment-emergent adverse events assessed by CTCAE v5.0
Overall survival following the diagnosis of high-risk HSCT-TMA
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Narsoplimab single arm-treatmentExperimental Treatment1 Intervention
Narsoplimab 4 mg/kg

Find a Location

Who is running the clinical trial?

Omeros CorporationLead Sponsor
28 Previous Clinical Trials
3,785 Total Patients Enrolled

Media Library

Narsoplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05855083 — Phase 2
Thrombotic Microangiopathy Research Study Groups: Narsoplimab single arm-treatment
Thrombotic Microangiopathy Clinical Trial 2023: Narsoplimab Highlights & Side Effects. Trial Name: NCT05855083 — Phase 2
Narsoplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05855083 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting individuals aged 50 or above?

"This clinical trial calls for participants aged 28 Days to 17 years old. 29 studies are designed specifically for minors, while 38 trials enlist subjects who have surpassed the age of 65."

Answered by AI

Is Narsoplimab a safe and viable treatment option for individuals?

"Our team at Power ranks Narsoplimab single arm-treatment's safety as a 2, due to the lack of efficacy data from its Phase 2 trial."

Answered by AI

Is this experiment still available for participants?

"Affirmative. Clinicaltrials.gov indicates that this medical research, which was initially posted on May 1st 2023, is currently recruiting individuals to take part in the study. Approximately 18 participants need to be recruited from 17 different clinical sites."

Answered by AI

How many healthcare centers are currently facilitating this trial?

"The current recruitment phase of this research is taking place at 17 distinct medical centres. These locations span from San Diego to Boston and many other places in between. To limit time spent traveling, it is best that participants choose a clinic near them for enrollment purposes."

Answered by AI

What is the pinnacle number of participants that are permitted to take part in this research?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this experiment is actively seeking out suitable candidates, which began recruiting since May 1st 2023 and was last modified two days later. This endeavor requires 18 participants to be enrolled at 17 distinct sites."

Answered by AI

Is it permissible for me to join this medical study?

"To be suitable for enrolment, potential candidates must fall between 28 days and 17 years of age while exhibiting thrombotic microangiopathy. This trial is seeking around 18 participants in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
2023. "Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05855083.
~11 spots leftby Dec 2025
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