NCT01000051

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 17, 2010

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 30, 2019

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

8.1 years

First QC Date

October 20, 2009

Results QC Date

June 18, 2019

Last Update Submit

September 6, 2023

Conditions

Thrombocytopenia

Keywords

Transplant ThrombocytopeniaHematopoietic cell transplantationHCTLow platelet countBleedingBlood clotStem Cell TransplantBlood And Marrow TransplantationEltrombopagPromacta

Outcome Measures

Primary Outcomes (1)

  • Comparing the Efficacy of Eltrombopaq and Placebo

    Comparison of the efficacy of eltrombopag and placebo in patients with thrombocytopenia post hematopoietic cell transplantation (HCT).

    Baseline to Day 57

Study Arms (2)

Eltrombopag

EXPERIMENTAL

Starting dose 50 mg/day orally for 8 weeks

Drug: Eltrombopag

Placebo

PLACEBO COMPARATOR

Once a day orally for 8 weeks

Drug: Placebo

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.

Also known as: Promacta
Eltrombopag
PlaceboDRUG

Once a day, orally for 8 weeks.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>/= 35 days post HCT with Platelet count \</= 20 x 10\^9/l sustained for 7 days or patients are platelet transfusion dependent, and
  • Neutrophil count \>/= 1.5 x 10\^9/l anytime within the last seven days before enrollment. Patients can be on myeloid or erythroid growth factors for example filgrastim), and
  • Age \>/= 18

You may not qualify if:

  • Recurrence or progression of primary malignancy after HCT
  • ALT \>/= 2.5 times the ULN
  • Serum bilirubin \>2mg/dl (unless due to Gilbert's syndrome)
  • Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study.
  • ECOG Performance status \>2
  • Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization. A negative pregnancy test result will be required before any study drug is given.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

ThrombocytopeniaHemorrhageThrombosis

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Popat, Uday / Professor, Stem Cell Transplantation
Organization
MD Anderson Cancer Center
upopat@mdanderson.org
713-745-3055

Study Officials

  • Uday Popat, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 22, 2009

Study Start

February 17, 2010

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

September 18, 2023

Results First Posted

July 30, 2019

Record last verified: 2023-09

Locations

US(1)