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Thrombopoietin Receptor Agonist

Eltrombopag vs Standard Treatment for ITP in Children

Q: How does Eltrombopag's clinical trial history compare to similar drugs?

<p>Eltrombopag was first trialled in 2011 at the National Institutes of Health Clinical Centre. In the decade since, there have been one hundred completed studies with 25 active investigations taking place currently. Many of these are based in Columbus, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.</p>

Phase 3

Waitlist Available

Led By Jenny Despotovic, DO

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Upfront treatment: Patient within 10 days of ITP diagnosis who has not received previous treatment OR Treatment failure: Patients who have failed standard management (observation or treatment with one or more first-line agents)

Treatment options include one of three standard therapies, (IVIg, steroids, or Anti-D). For example, if patient has previously shown no response to IVIg or steroids and is Rh-negative, patient would not be eligible for study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new treatment for ITP in children aged 1-18.

Who is the study for?

This trial is for children aged 1 to less than 18 with newly diagnosed ITP, a condition causing low platelet count. They must not have received prior treatment or have failed standard treatments like IVIG, steroids, or Anti-D. Participants need pharmacologic treatment and should be able to return for lab studies.Check my eligibility

What is being tested?

The study compares Eltrombopag against three standard therapies (IVIG, Rho(D) Immune Globulin, Steroids) in treating ITP in children. It's an open label phase 3 trial where participants are randomly assigned to receive either the new intervention or one of the standard options.See study design

What are the potential side effects?

Eltrombopag may cause liver issues, infections that don't respond well to drugs, heart problems if there's pre-existing cardiac disease, bleeding risks especially if severe bleeding has occurred before and potential cataract development.

Eligibility Criteria

Inclusion Criteria

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

Select...

I was diagnosed with ITP within the last 10 days and haven't been treated, or my initial ITP treatments didn't work.

Select...

I have not responded to IVIg, steroids, or Anti-D and am Rh-negative.

Select...

I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Proportion of patients with a platelet response

Secondary outcome measures

Bleeding Score

Blood Iron values

Hockenberry Fatigue Scale-Parent

+7 more

Other outcome measures

Change in Hockenberry fatigue

Extreme thrombocytosis

Global Change Scale scores

+7 more

Side effects data

From 2014 Phase 3 trial • 92 Patients • NCT01520909

17%

Nasopharyngitis

16%

Rhinitis

13%

Epistaxis

11%

Upper respiratory tract infection

11%

Cough

10%

Headache

10%

Abdominal pain

Pyrexia

Aspartate Aminotransferase increased

Decreased appetite

Alanine Aminotransferase increased

Vitamin D deficiency

Abdominal pain upper

Oropharyngeal pain

Rash

Toothache

Diarrhoea

Activated partial thromboplastin time prolonged

Blood alkaline Phosphatase increased

Blood creatinine increased

Bronchitis

Contusion

Gingival bleeding

Mouth haemorrhage

Nausea

Rhinorrhoea

Vomiting

Soft tissue injury

Constipation

Groin pain

Furuncle

Cellulitis

Retinal vascular disorder

Dyspepsia

Osteoporosis

Pneumonia fungal

Ear pain

Allergy to chemicals

Paraesthesia

Gingivitis

Excoriation

Rash pruritic

Impetigo

Anaemia

Dermatitis allergic

Influenza like illness

Lip haemorrhage

Menorrhagia

Viral pharyngitis

Pneumonia

Influenza

Joint injury

Lice infestation

Motion sickness

Pharyngitis

Platelet count increased

Somnolence

Subcutaneous abscess

Tongue haemorrhage

Tonsillar hypertrophy

Meningitis aseptic

Alanine aminotransferase abnormal

Aspartate aminotransferase abnormal

Gastritis

Asthenia

Back pain

Bronchospasm

Bulimia nervosa

Non-cardiac chest pain

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Placebo

Part 1: Eltrombopag

Part 2: Eltrombopag

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EltrombopagExperimental Treatment1 Intervention

Patients randomized to eltrombopag will be treated for 12 weeks, with the possibility to continue therapy for up to 1 year depending on response.

Group II: Standard first-line therapyActive Control3 Interventions

Subjects randomized to the standard therapy arm will receive one of three treatments at the discretion of the treating physician. Patients who previously failed standard management prior to study entry must be treated with a different agent than their original failed agent. e.g. Patient who failed steroids could receive either IVIg or anti-D if randomized to the standard treatment arm. Standard therapy will be administered as commercially available drug. Investigator may choose amongst the following: IVIg: IVIG 1 g/kg x1 (no steroids for pre-medication or adjunctive therapy) Steroids: Prednisone/Prednisolone 4 mg/kg/day (Max 120 mg/day) x 4 days Rho(D) Immune Globulin: Anti-D globulin 75 mcg/kg x1 (no steroids for pre-medication or adjunctive therapy)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eltrombopag

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,090 Total Patients Enrolled

Boston Children's HospitalOTHER

761 Previous Clinical Trials

5,579,608 Total Patients Enrolled

University of California, San FranciscoOTHER

2,506 Previous Clinical Trials

15,238,433 Total Patients Enrolled

Media Library

Thrombocytopenic Purpura Research Study Groups: Standard first-line therapy, Eltrombopag

Thrombocytopenic Purpura Clinical Trial 2023: Eltrombopag Highlights & Side Effects. Trial Name: NCT03939637 — Phase 3

Frequently Asked Questions

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

If a patient is below the age of 40, can they still partake in this research project?

"This trial is open to participants that are aged between 1 year old and 18 years old."

Answered by AI

Are there any current vacancies in this clinical trial?

"The most recent information available on clinicaltrials.gov affirms that this study is still enrolling patients. This particular trial began recruiting on May 2nd, 2019 and the data was last updated September 28th, 2021. There are currently 162 people enrolled at 13 different locations."

Answered by AI

Could you please explain the dangers of Eltrombopag?

"Eltrombopag is considered safe according to our 3-point scale because it has progressed to Phase 3 trials. This signifies that, not only does some data support its efficacy, but there are multiple rounds of data affirming its safety."

Answered by AI

How many test subjects are included in this clinical trial?

"This clinical trial requires 162 participants that meet the pre-determined inclusion criteria. The study is being conducted at Nationwide Children's Hospital in Columbus, Ohio and Phoenix CHildren's Hospital in Phoenix, Arizona."

Answered by AI

At how many different hospitals is this study being conducted?

"Patients are currently being enrolled at this trial's 13 clinical sites. The locations of these centres include Columbus, Phoenix and San Francisco as well as other cities. If you are considering participating in this study, it may be helpful to choose the location that is closest to you so that travel demands are minimized."

Answered by AI

What are the prerequisites for joining this clinical trial?

"This medical trial is looking for 162 participants who are between the ages of 1 and 18 and have purpura, thrombocytopenic, or idiopathic. In addition to meeting those criteria, eligible patients must also: require pharmacologic treatment from the perspective of the treating clinician; be at the discretion of the investigator for needing treatment, but there should be clinical equipoise about the use of eltrombopag vs standard treatment options (patients should not, in the opinion of the investigator, require concomitant therapy at time of enrollment); age: 1- <18 years; upfront treatment"

Answered by AI

How does Eltrombopag's clinical trial history compare to similar drugs?

"Eltrombopag was first trialled in 2011 at the National Institutes of Health Clinical Centre. In the decade since, there have been one hundred completed studies with 25 active investigations taking place currently. Many of these are based in Columbus, Ohio."

Answered by AI