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Cardioprotectant

Dexrazoxane for Congenital Heart Defects

Phase 1
Waitlist Available
Research Sponsored by University of Texas at Austin
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 60 days
Awards & highlights

Study Summary

This study is evaluating whether a drug called Dexrazoxane can be safely administered to young children with congenital heart disease.

Eligible Conditions
  • Congenital Heart Defects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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
Area under the plasma concentration vs time curve (AUC)
Minimum plasma concentration (Cmin)
Peak Plasma Concentration (Cmax)
+1 more
Secondary outcome measures
Composite outcome for neonatal cardiac surgery
Hospital Length of Stay
ICU Length of Stay
+7 more

Side effects data

From 2022 Phase 2 trial • 73 Patients • NCT02584309
100%
Anemia
100%
Alopecia
90%
Lymphocytes decreased
80%
Nausea
70%
Fatigue
70%
Hypocalcemia
60%
Hypokalemia
60%
Constipation
50%
Alkaline phosphatase increased
50%
Creatinine increased
50%
Anxiety
40%
White blood cell decreased
40%
Headache
30%
Febrile neutropenia
30%
Diarrhea
30%
Mucositis oral
30%
Hypernatremia
30%
Neutrophil count decreased
30%
Platelet count decreased
30%
Bone pain
30%
Hyponatremia
20%
Pain in extremity
20%
Fever
20%
Hyperglycemia
20%
Hypertriglyceridemia
20%
Back pain
20%
Peripheral sensory neuropathy
20%
Hypoalbuminemia
20%
Flushing
20%
Thromboembolic event
10%
Pruritus
10%
Respiratory failure
10%
Abdominal pain
10%
Flu like symptoms
10%
Sinus tachycardia
10%
Sinus bradycardia
10%
Alanine aminotransferase increased
10%
Stomach pain
10%
Oral dysethesia
10%
Vomiting
10%
Edema limbs
10%
Rash acneiform
10%
Wound complication
10%
Lung infection
10%
Anorexia
10%
Pharyngitis
10%
Rash pustular
10%
Fracture
10%
Spasticity
10%
INR increased
10%
Hypercalcemia
10%
Hypermagnesemia
10%
Chest wall pain
10%
Sinus pain
10%
Myositis
10%
Myalgia
10%
Dyspnea
10%
Hoarseness
10%
Hematuria
10%
Proteinuria
10%
Nasal congestion
10%
Depression
10%
Pneumothorax
10%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
Arm 1: Doxorubicin and Upfront Dexrazoxane

Trial Design

1Treatment groups
Experimental Treatment
Group I: DexrazoxaneExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexrazoxane
FDA approved

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
358 Previous Clinical Trials
81,701 Total Patients Enrolled
Dell Children's Medical Center of Central TexasOTHER
6 Previous Clinical Trials
5,004,411 Total Patients Enrolled
~3 spots leftby Jun 2025
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