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Thrombopoietin Receptor Agonist

Eltrombopag for Aplastic Anemia

Phase 2

Waitlist Available

Led By Cynthia E Dunbar, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial is testing whether eltrombopag can help improve blood counts in patients with severe aplastic anemia. Participants will take the drug for 6 months, with blood and bone marrow samples being collected periodically to assess the drug's effects.

Eligible Conditions

Severe Aplastic Anemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Drug Response as Defined by Clinically-signficant Hematologic Improvements

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

1Treatment groups

Experimental Treatment

Group I: EltrombopagExperimental Treatment1 Intervention

Administration of eltrombopag at a dose of 150mg/day for 6 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eltrombopag

2013

Completed Phase 4

~970

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor

3,837 Previous Clinical Trials

47,851,587 Total Patients Enrolled

11 Trials studying Aplastic Anemia

922 Patients Enrolled for Aplastic Anemia

Cynthia E Dunbar, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

2 Previous Clinical Trials

77 Total Patients Enrolled

Frequently Asked Questions

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

Has Eltrombopag acquired regulatory support from the FDA?

"Considering there is some safety evidence but no efficacy data, our team ranks Eltrombopag's safety with a score of 2."

Answered by AI

Does this medical experiment currently have open enrollment?

"Patient recruitment for this clinical trial has been closed; the posting went live on June 28th 2013 and was last updated March 25th 2022. However, individuals seeking participation in anemia studies can choose from 243 available trials while those interested in Eltrombopag options have 23 active opportunities to explore."

Answered by AI

May I be included in this medical experiment?

"To qualify for this research, applicants must be anemic and between the ages 2 to 100. In total, 40 participants are being enrolled."

Answered by AI

What is the sample size of this investigation?

"At this moment in time, this medical trial is not welcoming new participants. Its initial posting was June 28th 2013 and its last update occurred on March 25th 2022. If you are searching for alternate studies, 243 trials with anemia as their primary focus are presently enrolling patients while 23 clinical experiments researching eltrombopag have current openings."

Answered by AI

Does this exploration permit individuals aged eighty-five and older to participate?

"The eligibility requirements for this medical trial dictate that patients should have an age between two and one hundred. Additionally, there are 118 trials designed for minors and 190 studies available to persons beyond the retirement age."

Answered by AI

Recent research and studies

BloodJournal

Treatment Optimization and Genomic Outcomes in Refractory Severe Aplastic Anemia Treated with Eltrombopag

Winkler, Thomas, Xing Fan, James Cooper, Ronan Desmond, David J. Young, Danielle M. Townsley, Phillip Scheinberg, et al.. 2019. “Treatment Optimization and Genomic Outcomes in Refractory Severe Aplastic Anemia Treated with Eltrombopag”. Blood. American Society of Hematology. doi:10.1182/blood.2019000478.

BloodJournal

Eltrombopag Mobilizes Iron in Patients with Aplastic Anemia

Zhao, Zhen, Qian Sun, Lori J. Sokoll, Michael Streiff, Zhe Cheng, Sophie Grasmeder, Danielle M. Townsley, Neal S. Young, Cynthia E. Dunbar, and Thomas Winkler. 2018. “Eltrombopag Mobilizes Iron in Patients with Aplastic Anemia”. Blood. American Society of Hematology. doi:10.1182/blood-2018-01-826784.

clinicaltrials.govStudy

Extended Dosing With Eltrombopag for Severe Aplastic Anemia

2013. "Extended Dosing With Eltrombopag for Severe Aplastic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01891994.