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Eltrombopag for Post Transplant Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000051
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: Eltrombopag Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Eltrombopag for Post Transplant Thrombocytopenia
Actual Study Start Date : February 17, 2010
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

Arm Intervention/treatment
Experimental: Eltrombopag
Starting dose 50 mg/day orally for 8 weeks
Drug: Eltrombopag
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.
Other Name: Promacta

Placebo Comparator: Placebo
Once a day orally for 8 weeks
Drug: Placebo
Once a day, orally for 8 weeks.




Primary Outcome Measures :
  1. Comparing the Efficacy of Eltrombopaq and Placebo [ Time Frame: Baseline to Day 57 ]
    Comparison of the efficacy of eltrombopag and placebo in patients with thrombocytopenia post hematopoietic cell transplantation (HCT).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients >/= 35 days post HCT with Platelet count </= 20 x 10^9/l sustained for 7 days or patients are platelet transfusion dependent, and
  2. 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
  3. Age >/= 18

Exclusion Criteria:

  1. Recurrence or progression of primary malignancy after HCT
  2. ALT >/= 2.5 times the ULN
  3. Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)
  4. 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.
  5. ECOG Performance status >2
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000051


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Investigators
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Study Chair: Uday Popat, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01000051    
Other Study ID Numbers: 2009-0106
NCI-2011-01099 ( Registry Identifier: NCI CTRP )
First Posted: October 22, 2009    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Transplant Thrombocytopenia
Hematopoietic cell transplantation
HCT
Low platelet count
Bleeding
Blood clot
Stem Cell Transplant
Blood And Marrow Transplantation
Eltrombopag
Promacta
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases