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Monoclonal Antibodies

Eculizumab for Thrombotic Microangiopathy

Phase 2
Waitlist Available
Led By Sonata Jodele, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients of any age undergoing allogeneic or autologous HCT
Histologic TMA diagnosis OR clinical TMA diagnosis and presenting with high risk disease features including elevated plasma sC5b-9 above laboratory normal value (≥244ng/ml) and proteinuria measured as ≥30mg/dL of protein on random urinalysis x2 or protein/creatinine ratio ≥1mg/mg or patient receiving renal replacement therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a drug called eculizumab can help people with a complication from hematopoietic stem cell transplantation (HCT) called thrombotic microangiopathy (TMA). The investigators think that eculizumab might help people with TMA to live longer.

Eligible Conditions
  • Thrombotic Microangiopathy
  • Multiple Organ Dysfunction Syndrome
  • Atypical Hemolytic Uremic Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival
Secondary outcome measures
Non-relapse Mortality
Number of Participants With Organ Dysfunction

Side effects data

From 2011 Phase 4 trial • 7 Patients • NCT00867932
71%
Headache
29%
Abdominal pain upper
29%
Cough
29%
Pyrexia
29%
Upper respiratory tract infection
25%
Menorrhagia
25%
Vaginal haemorrhage
25%
Vulvovaginal pruritus
25%
Vaginal discharge
14%
Fatigue
14%
Lymph node pain
14%
Haemolysis
14%
Acute sinusitis
14%
Catheter site cellulitis
14%
Otitis media acute
14%
Diarrhoea
14%
Nausea
14%
Nasal congestion
14%
Rhinorrhoea
14%
Acne
14%
Petechiae
14%
Rash
14%
Rash papular
14%
Contusion
14%
Blood glucose increased
14%
Decreased appetite
14%
Pain in extremity
14%
Chromaturia
14%
Skin hyperpigmentation
14%
Swelling face
14%
Hypotension
14%
Anaemia
14%
Aplastic anaemia
14%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eculizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: EculizumabExperimental Treatment1 Intervention
All patients will receive eculizumab based on their weight for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eculizumab
2021
Completed Phase 4
~1190

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
813 Previous Clinical Trials
6,531,518 Total Patients Enrolled
Sonata Jodele, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
1 Previous Clinical Trials
2 Total Patients Enrolled

Frequently Asked Questions

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

Is there still an opportunity for enrolment in this experiment?

"At this time, this research trial is not currently recruiting. The study was initially publicized on August 3rd 2018 and its details were updated November 23rd 2022. For individuals interested in participating in similar studies there are 1531 trials that centre around thrombotic microangiopathies, as well as 13 separate experiments employing Eculizumab therapy seeking participants."

Answered by AI

What safety considerations must be taken into account when administering Eculizumab?

"The safety of Eculizumab is estimated to be a 2, as it has been tested in Phase 2 trials and some initial evidence of its security exists but there are no studies that confirm efficacy."

Answered by AI

How extensive is the scope of this research study?

"Unfortunately, this clinical trial is not open for recruitment at the present moment. It was originally posted on August 3rd 2018 and recently updated on November 23rd 2022. If you are interested in other medical experiments concerning thrombotic microangiopathies, there are presently 1531 options available; 13 of these involve Eculizumab as a treatment option."

Answered by AI

Are there other precedents of employing Eculizumab in clinical research?

"Currently, there are 8 Phase 3 trials and 5 additional clinical studies exploring eculizumab. Whittier is the epicentre for these investigations with a total of 594 sites participating in all 13 active tests."

Answered by AI

What medical conditions is eculizumab traditionally employed to address?

"Eculizumab is an efficient treatment option for patients suffering from myasthenia gravis, generalized neuromyelitis optica and paroxysmal nocturnal hemoglobinuria (PNH)."

Answered by AI

Is this medical trial unique in its methodology?

"Eculizumab has been under clinical scrutiny since 2016, when it was first tested in a trial funded by Alexion Pharmaceuticals. This initial study involving 270 participants led to the drug being approved for Phase 3 trials and today there are 13 ongoing tests of Eculizumab spanning 121 cities and 42 nations."

Answered by AI
~3 spots leftby Mar 2025