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IVIG for Atrioventricular Block

University of Colorado, Denver (UCD), Aurora, CO
Atrioventricular Block+1 More ConditionsIVIG - Drug
Eligibility
18+
Female

Study Summary

This trial is investigating a way to improve the treatment of a heart condition called fetal complete atrioventricular block (3° AVB). This heart condition is almost always caused by a mother's antibodies, and it is fatal in 1/5 of cases. Current treatment for 3° AVB is not effective, so this trial is testing a new way to treat it.

Eligible Conditions
  • Atrioventricular Block
  • Fetal Atrioventricular Block

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year post-birth

1 year post-birth
Percentage of 2° AVB subjects who maintain NR at age 1 year.
At birth
Percentage of AV interval > 170 msec subjects with NR at birth
Year 1
Incidences of isolated extra-nodal cardiac disease
Week 25
Percentage of 2° AVB subjects with NR (1:1 AV conduction) at birth

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Stellate ganglion block
1
Active
1
Stellate Ganglion Block

Side Effects for

Infliximab
17%Continued Fever after treatment completion and crossover to other study treatment
15%Fever following crossover treatment
15%Fever after discharge not attributed to KD
6%GI Symptoms
4%Rash
4%Arthritis/pain and swelling in extremities
4%Epistaxis
2%Leukemoid Reaction
2%Hemolytic Anemia
2%Dress Syndrome
2%Pancreatitis
2%Pain (IV Site)
2%Headache
2%Chest Pain
2%Color Blindness
2%Hyperhidrosis
2%URI
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03065244) in the Infliximab ARM group. Side effects include: Continued Fever after treatment completion and crossover to other study treatment with 17%, Fever following crossover treatment with 15%, Fever after discharge not attributed to KD with 15%, GI Symptoms with 6%, Rash with 4%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms
1 of 1

Experimental Treatment

1300 Total Participants · 1 Treatment Group

Primary Treatment: IVIG · No Placebo Group · Phase 3

Mothers with Fetuses Who Have 2° AVB or AV interval > 170msExperimental Group · 2 Interventions: Dexamethasone, IVIG · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
IVIG
2016
Completed Phase 4
~2940

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post-birth

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,306 Previous Clinical Trials
760,486 Total Patients Enrolled
Jill Buyon, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
307 Total Patients Enrolled
Bettina Cuneo, MDPrincipal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age 18+ · Female Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

How is IVIG typically used to help patients?

"IVIG is the standard form of treatment for ophthalmia, sympathetic. Additionally, this medication can be used to manage branch retinal vein occlusion and macular edema." - Anonymous Online Contributor

Unverified Answer

What is the previous research on IVIG that this study expands upon?

"The immunoglobulin therapy commonly known as IVIG was first explored in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been 1118 completed studies and 579 active trials, with a significant concentration of research being conducted in Burlington, Vermont." - Anonymous Online Contributor

Unverified Answer

Is this study still seeking participants?

"Correct. Based on the information available from clinicaltrials.gov, this study is currently looking for 1300 participants across 37 different locations. The trial was first posted on August 1st 2020 and has since been updated January 11th 2022." - Anonymous Online Contributor

Unverified Answer

Could you please tell me the risks associated with IVIG treatments?

"There is prior clinical data supporting IVIG's safety, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

How many places are testing this new treatment?

"Currently, 37 different locations are running this trial. The sites in Burlington, Edmonton and Las Vegas as well as other cities offer this study. If you choose to participate, it may be helpful to pick a location near to reduce travel time and expenses." - Anonymous Online Contributor

Unverified Answer

How many research subjects are involved in this project?

"In order to complete this clinical trial, 1,300 individuals that meet the specified inclusion criteria must enroll. These potential participants can be located at University of Vermont Children's Hospital in Burlington or Stollery Children's Hospital in Edmonton." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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