Eculizumab for Newborn Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Newborn Illness+4 MoreEculizumab - Drug
Eligibility
18 - 50
Female
What conditions do you have?
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Study Summary

This trial is testing whether the drug eculizumab can help treat HELLP syndrome, a disease affecting pregnant women. The drug blocks part of the immune system. Researchers will see if the drug is effective and benefits both the mother and fetus.

Eligible Conditions
  • Newborn Illness
  • Maternal Injury
  • HELLP Syndrome
  • Pre-Eclampsia, Severe
  • Complement Deficiency

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Baseline, 72 hours

Baseline, 72 hours
Change in alanine aminotransferase (ALT)
Change in aspartate aminotransferase (AST) level
Body Weight Changes
Up to 36 days
Maternal postpartum length of stay
Up to 7 days
Latency of pregnancy
Blood Transfusion

Trial Safety

Safety Progress

1 of 3

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1
Low-dose aspirin
1
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1
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Side Effects for

Eculizumab
71%Headache
29%Upper respiratory tract infection
29%Cough
29%Pyrexia
29%Abdominal pain upper
25%Vulvovaginal pruritus
25%Menorrhagia
25%Vaginal haemorrhage
25%Vaginal discharge
14%Blood glucose increased
14%Swelling face
14%Contusion
14%Fatigue
14%Acne
14%Skin hyperpigmentation
14%Otitis media acute
14%Anaemia
14%Thrombocytopenia
14%Haemolysis
14%Nausea
14%Rash papular
14%Petechiae
14%Diarrhoea
14%Lymph node pain
14%Catheter site cellulitis
14%Hypotension
14%Decreased appetite
14%Pain in extremity
14%Chromaturia
14%Rhinorrhoea
14%Nasal congestion
14%Rash
14%Aplastic anaemia
14%Acute sinusitis
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT00867932) in the Eculizumab ARM group. Side effects include: Headache with 71%, Upper respiratory tract infection with 29%, Cough with 29%, Pyrexia with 29%, Abdominal pain upper with 29%.

Trial Design

1 Treatment Group

HELLP Syndrome at less than 30 weeks gestation
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Eculizumab · No Placebo Group · Phase 1

HELLP Syndrome at less than 30 weeks gestation
Drug
Experimental Group · 1 Intervention: Eculizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eculizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 72 hours

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,250,123 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,076 Previous Clinical Trials
31,020,178 Total Patients Enrolled
Arthur J VaughtPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18 - 50 · Female Participants · 1 Total Inclusion Criteria

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