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Thrombopoietin Receptor Agonist

eltrombopag for Thrombocytopenic Purpura (TAPER Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, 6, 9, 12 (end of treatment visit for non-responders), 15, 18, 21 and 24 (end of treatment visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Awards & highlights

TAPER Trial Summary

This trial will assess whether eltrombopag can help ITP patients who have relapsed or failed to respond to initial treatment with steroids achieve sustained remission.

Eligible Conditions
  • Thrombocytopenic Purpura

TAPER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, 6, 9, 12 (end of treatment visit for non-responders), 15, 18, 21 and 24 (end of treatment visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, 6, 9, 12 (end of treatment visit for non-responders), 15, 18, 21 and 24 (end of treatment visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Sustained Response Off Treatment (SRoT) by 12 Months
Secondary outcome measures
Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score
+19 more

Side effects data

From 2008 Phase 3 trial • 197 Patients • NCT00370331
30%
Headache
13%
Nausea
13%
Diarrhoea
10%
Nasopharyngitis
10%
Fatigue
10%
Upper respiratory tract infection
7%
Pharyngitis
7%
Alanine aminotransferase (ALT) increased
7%
Vomiting
7%
Pain in extremity
7%
Oropharyngeal pain
7%
Arthralgia
7%
Back pain
6%
Myalgia
6%
Urinary tract infection
5%
Abdominal pain upper
5%
Influenza
5%
Aspartate aminotransferase (AST) increased
5%
Cough
5%
Epistaxis
4%
Constipation
4%
Pruritus
4%
Dizziness
2%
Insomnia
2%
Conjunctival haemorrhage
1%
Cellulitis
1%
Dyspepsia
1%
Loss of consciousness
1%
Aortic aneurysm
1%
Deep vein thrombosis
1%
Pulmonary infarction
1%
Oedema peripheral
1%
Transaminases increased
1%
Duodenal ulcer haemorrhage
1%
Pulmonary embolism
1%
Thrombophlebitis superficial
1%
Rectosigmoid cancer
1%
Ecchymosis
1%
Cataract
1%
Neck pain
1%
Intra-abdominal haemorrhage
1%
Spinal compression fracture
1%
Hypokalaemia
1%
Haemorrhagic anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eltrombopag 50 mg QD

TAPER Trial Design

1Treatment groups
Experimental Treatment
Group I: eltrombopagExperimental Treatment1 Intervention
Participants were treated with eltrombopag to induce sustained response off treatment to reach a target platelet count of >=100×10^9/L (CR), after 1st line steroids had failed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eltrombopag
2009
Completed Phase 4
~1740

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,139 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
2018. "A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03524612.
~16 spots leftby Apr 2025
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