CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Eltrombopag +1 moredrug
Likely dose
Eltrombopag 50 mg orally once daily (East Asians 25 mg daily) for 8 weeksAI-extracted
Key inclusion· 4
  • ✓≥35 days post-HCT (hematopoietic cell transplant)
  • ✓Platelet count ≤20 × 10^9/L sustained for 7 days OR platelet transfusion dependent
  • ✓Absolute neutrophil count ≥1.5 × 10^9/L within 7 days before enrollment (on or off myeloid/erythroid growth factors)
  • ✓Age ≥18 years
Key exclusion· 5
  • ✕Recurrence or progression of primary malignancy after HCT
  • ✕ALT ≥2.5 times the upper limit of normal
  • ✕Serum bilirubin >2 mg/dL (unless due to Gilbert's syndrome)
  • ✕Deep vein thrombosis within 1 year before enrollment (exception: upper arm thrombosis related to central venous catheters within 3 months allowed)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01000051
NCT01000051Phase 2Completed
CompareCT.gov

Eltrombopag for Post Transplant Thrombocytopenia

M.D. Anderson Cancer Center·interventional·Posted Oct 22, 2009·Updated Sep 18, 2023

In Brief

A Phase 2 clinical trial evaluating Eltrombopag and Placebo for Thrombocytopenia. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this drug will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2009
Enrollment StartFeb 17, 2010
Primary CompletionApr 4, 2018
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 16.7 years ago

Interventions

Eltrombopagdrug

Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily.

Placebodrug

Once a day, orally for 8 weeks.