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Complement Inhibitor

Nomacopan for Transplant-Associated Thrombotic Microangiopathy

Phase 3
Recruiting
Research Sponsored by AKARI Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical or histological diagnosis of TMA
Aged ≥ 0.5 and < 18 years at the time of diagnosis of TMA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Study Summary

This trial is testing a new medication to treat a complication from stem cell transplants in children.

Who is the study for?
This trial is for children and teenagers under 18 who've had a stem cell transplant within the last 100 days and are diagnosed with Thrombotic Microangiopathy (TMA). They must not be allergic to the drug being tested, weigh at least 5 kg, have no severe infections or acute GVHD grade 4, haven't used complement blocker therapy before, and don't have a positive ADAMTS13 test.Check my eligibility
What is being tested?
The study tests nomacopan (rVA576) in young patients with TMA following a stem cell transplant. It's conducted across multiple centers to see how well this treatment works for these patients. The participants will receive nomacopan after their diagnosis of TMA.See study design
What are the potential side effects?
While specific side effects of nomacopan in this context aren't listed here, common side effects may include reactions at the injection site, potential allergic responses due to hypersensitivity to ingredients, or complications related to immune system interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with TMA.
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I was diagnosed with TMA before turning 18 but after 6 months old.
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I have had a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RBC transfusion independence for ≥ 28 days immediately prior to any scheduled clinical visit up to Week 24
Urine protein creatinine ratio ≤ 2 mg/mg
Secondary outcome measures
Normalisation of lab parameters
Platelet transfusion independence
Renal Function Improvement
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: nomacopan (rVA576)Experimental Treatment1 Intervention
The study population will consist of paediatric patients who have undergone allogeneic or autologous HSCT and develop HSCT-TMA within a year of HSCT

Find a Location

Who is running the clinical trial?

AKARI TherapeuticsLead Sponsor
7 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

nomacopan (rVA576) (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04784455 — Phase 3
Thrombotic Microangiopathy Research Study Groups: nomacopan (rVA576)
Thrombotic Microangiopathy Clinical Trial 2023: nomacopan (rVA576) Highlights & Side Effects. Trial Name: NCT04784455 — Phase 3
nomacopan (rVA576) (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784455 — Phase 3

Frequently Asked Questions

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

Does this study have an age limit?

"According to the eligibility requirements listed on this clinical trial, applicants must be aged between 6 months and 18 years old. There are 7 studies available for children under 18 while there are 110 trials for adults over 65."

Answered by AI

Is this research being conducted in a significant number of hospitals across America?

"4 sites are currently running this clinical trial, with locations in Palo Alto, Durham, Philadelphia and 4 other cities. If you enroll in the study, selecting a location near to you will minimize travel requirements."

Answered by AI

Does the medical literature on nomacopan (rVA576) date back far?

"At present, there are two clinical trials underway that are studying the effects of nomacopan (rVA576). One of these trials is in Phase 3. In addition, while many of the trials for nomacopan (rVA576) are taking place in New york City, there are a total of eight different locations where these trials are being conducted."

Answered by AI

Do we have any previous data to compare these findings to?

"At present, there are 2 ongoing clinical trials for the drug known as nomacopan (rVA576). These trials are being conducted in 5 different cities across 3 countries. The earliest of these trials began in 2018 and was sponsored by AKARI Therapeutics. This particular trial involved 6 patients and completed its Phase 2 approval stage. Since 2018, 1 more trial has been completed."

Answered by AI

Has the FDA cleared nomacopan (rVA576) for use?

"There is both efficacy and safety data available for nomacopan (rVA576), so it received a score of 3."

Answered by AI

How many patients are being enrolled in this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that this study, which was originally advertised on February 1st 2021, is still recruiting patients. There are currently 4 sites open and 50 spots available for participants."

Answered by AI

Are there any volunteers currently signed up for this research?

"According to the clinicaltrials.gov website, this trial is still actively recruiting patients. The study was posted on February 1st, 2021 and was last updated on October 18th, 2022."

Answered by AI

What goals has this research set out to achieve?

"The primary focus of this 24-week study is to Urine protein creatinine ratio ≤ 2 mg/mg. Additionally, researchers will also be measuring for Safety and tolerability of nomacopan, Platelet transfusion independence, and Renal Function Improvement."

Answered by AI

Who meets the criteria to participate in this medical study?

"This specific medical trial aims to enroll 50 patients that are between 6 months and 18 years old that have thrombotic microangiopathies. meeting the following age criteria: Aged ≥ 0.5 and < 18 years at the time of diagnosis of TMA."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy
2021. "Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04784455.
~12 spots leftby Jun 2025
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