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Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Primary Purpose

Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Avatrombopag tablets
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Thrombocytopenic Purpura focused on measuring Chronic Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Confirmed diagnosis of ITP according to American Society of Hematology (ASH) Guidelines ≥ 3 months prior to Day 1.
  3. If ≥ 60 years old, must have had either a bone marrow biopsy consistent with ITP within past 3 years or a good response (platelet count > 100,000/mm^3) to a previous ITP treatment.
  4. Are refractory or relapsed after at least one prior ITP therapy (patients who are refractory and failed to achieve a platelet count ≥ 50,000/mm^3 despite steroids or ≥ 30,000/mm^3 to other prior ITP therapies, such as splenectomy, danazol, or immunosuppressive drugs. For patients who are relapsed, the platelet counts must be below 50,000/mm^3 if using steroids or 30,000/mm^3 if not prescribed steroids.)
  5. Patients receiving maintenance corticosteroids may be enrolled, as long as the corticosteroids have been administered at a stable dose (same milligram amount ± 10%) for ≥ 2 weeks prior to Screening Visit A and the investigator does not foresee the need to change the steroid dose during study participation. Patients should remain on this stable corticosteroid dose during study participation.
  6. Patients receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine or danazol may also be enrolled. The dosages of all these medications must be stable for at least 3 months prior to AKR-501 administration.
  7. Platelet count:

    • Patients not receiving steroids (no steroid treatment for > 2 weeks prior to the Screening Visit A): platelets < 30,000/mm^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B)
    • Patients receiving steroids: platelets < 50,000/mm^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B).
  8. Women of child-bearing potential must have a negative pregnancy test at Screening Visit A and Screening Visit B. (Childbearing potential is defined as any woman who has not been surgically sterilized and is premenopausal or peri-menopausal i.e., any menstrual flow within 12 months of Screening Visit A).
  9. Women of child-bearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used: condoms (male or female) with a spermicidal agent, diaphragm, or cervical cap with a spermicidal agent, IUD, hormonal contraception, abstinence).
  10. Willing and able to provide written informed consent before any study-related procedure.

Exclusion Criteria:

  1. Women who are pregnant and/or lactating.
  2. Splenectomy procedure performed 4 weeks prior to AKR-501 administration.
  3. Use of the following drugs or treatments prior to Day 1:

    • Within 3 months - Rituximab;
    • Within 2 weeks - Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).
  4. Participation in a clinical trial involving any investigational agent within 4 weeks of Day 1.
  5. Exposure to eltrombopag or AMG -531.
  6. Significant medical conditions or diseases as determined by the Investigator (e.g., clinically active systemic lupus erythematosus; known or suspected HIV infection; acute hepatitis or clinically active chronic hepatitis; lymphoproliferative disease; congestive heart failure).
  7. History of cardiovascular disease (e.g., angina, unstable angina, myocardial infraction, coronary artery stent placement, angioplasty, coronary artery bypass grafting).
  8. History of thromboembolic disease (e.g., transient ischemic attack [TIA], stroke [CVA], pulmonary embolism [PE]).
  9. History of deep venous thrombosis (DVT).
  10. History of lupus anticoagulant or anticardiolipin antibody syndrome or positive anti b2 glycoprotein antibody.
  11. History of any medical condition where systemic anticoagulation was required for more than 6 months.
  12. Laboratory abnormalities:

    • Hemoglobin < 12.5 g/dL for men and < 11.5 g/dL for women. If anemia is clearly related to ITP, for example excessive blood loss, then that patient may be enrolled without the need for a waiver after discussion with the Sponsor's medical monitor
    • White blood cell count (WBC) < lower limit of normal
    • Absolute neutrophil count (ANC) < 1000/mm^3
    • Prothrombin time (PT) > 1.25 x upper limit of normal
    • Partial thromboplastin time (PTT) > 1.25 x upper limit of normal
    • Total bilirubin > 3 x upper normal limit
    • Alanine transaminase (ALT) > 3 x upper normal limit
    • Aspartate transaminase (AST) > 3 x upper normal limit
    • Creatinine > 1.5x upper normal limit
    • Blood urea nitrogen (BUN) > 1.5 x upper normal limit
    • HIV positive
    • IgM HAV positive, Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV) positive.
  13. History of, or current alcohol or drug abuse likely to interfere with ability to comply with protocol.

    requirements or give informed consent, as determined by the Investigator.

  14. History of, or current psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent, as determined by the Investigator.
  15. Currently taking any of the following medications: Rituximab, Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).

Sites / Locations

  • Pacific Cancer Medical Center, Inc
  • Comprehensive Blood and Cancer Center
  • Bay Area Cancer Research Group, LLC
  • Pacific Coast Hematology/Oncology Medical Group Inc.
  • University of California Irvine Cancer Center
  • Davis, Posteraro and Wasser, MDs, LLP
  • Georgetown University
  • Florida Cancer Institute
  • Columbus Clinic, PC
  • John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology
  • Comprehensive Bleeding Disorders Center
  • Cancer Care Center, Inc.
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Capitol Comprehensive Cancer Care Clinic
  • Kansas City Cancer Center, LLC
  • UMDNJ - Robert Wood Johnson Medical School
  • Mount Sinai Medical Center
  • New York Presbyterian Hospital, Weill Medical College of Cornell University
  • Emerywood Oncology and Hematology
  • Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center
  • UPENN
  • Western Pennsylvania Hospital
  • Cancer Centers of the Carolina
  • Puget Sound Blood Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Avatrombopag tablets

Placebo tablet

Arm Description

2.5, 5, 10 or 20 mg tablets 1 tablet taken orally once daily for 28 days

2.5, 5, 10, or 20 mg tablets 1 tablet taken orally once daily for 28 days

Outcomes

Primary Outcome Measures

Responder Rate (RR) to Avatrombopag on Day 28
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).

Secondary Outcome Measures

Change in Platelet Count From Baseline
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28. The unit of measure was "K/mm^3", where "K = platelets x 1000 = platelets x 10^3" and "mm^3 = cubic milliliter= microliter".
Responder Rate to Avatrombopag by Visit
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, and 21. The RR was summarized by treatment group using the method of LOCF. Day 28 was not included with this data because it was reported as a primary outcome measure.
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.

Full Information

First Posted
February 27, 2007
Last Updated
February 6, 2018
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00441090
Brief Title
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Official Title
A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP).
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).
Detailed Description
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of avatrombopag will also be studied. Approximately 65 eligible participants will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either avatrombopag 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each avatrombopag dosing group will consist of 15 participants while the placebo group will consist of 5 participants. All study participants will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) avatrombopag PK while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42). At the completion of Visit Day 28±1, participants who complete 28±1 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 (NCT00625443) based on this visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
Keywords
Chronic Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, ITP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avatrombopag tablets
Arm Type
Experimental
Arm Description
2.5, 5, 10 or 20 mg tablets 1 tablet taken orally once daily for 28 days
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
2.5, 5, 10, or 20 mg tablets 1 tablet taken orally once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
Avatrombopag tablets
Other Intervention Name(s)
AKR-501, E5501, YM477
Intervention Description
Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
Primary Outcome Measure Information:
Title
Responder Rate (RR) to Avatrombopag on Day 28
Description
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).
Time Frame
Day-4 to Day 1, Baseline, Day 28
Secondary Outcome Measure Information:
Title
Change in Platelet Count From Baseline
Description
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28. The unit of measure was "K/mm^3", where "K = platelets x 1000 = platelets x 10^3" and "mm^3 = cubic milliliter= microliter".
Time Frame
Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, Day 28
Title
Responder Rate to Avatrombopag by Visit
Description
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, and 21. The RR was summarized by treatment group using the method of LOCF. Day 28 was not included with this data because it was reported as a primary outcome measure.
Time Frame
Day -4 to Day 1, Baseline, Day 7, Day 14, and Day 21
Title
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Description
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Time Frame
Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Title
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Description
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Time Frame
Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Title
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Description
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Time Frame
Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Other Pre-specified Outcome Measures:
Title
To Evaluate the Pharmacokinetics (PK) and the Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship of Avatrombopag in Patients With ITP.
Description
Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.
Time Frame
Days 7, 14, 21 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ≥ 18 years of age. Confirmed diagnosis of ITP according to American Society of Hematology (ASH) Guidelines ≥ 3 months prior to Day 1. If ≥ 60 years old, must have had either a bone marrow biopsy consistent with ITP within past 3 years or a good response (platelet count > 100,000/mm^3) to a previous ITP treatment. Are refractory or relapsed after at least one prior ITP therapy (patients who are refractory and failed to achieve a platelet count ≥ 50,000/mm^3 despite steroids or ≥ 30,000/mm^3 to other prior ITP therapies, such as splenectomy, danazol, or immunosuppressive drugs. For patients who are relapsed, the platelet counts must be below 50,000/mm^3 if using steroids or 30,000/mm^3 if not prescribed steroids.) Patients receiving maintenance corticosteroids may be enrolled, as long as the corticosteroids have been administered at a stable dose (same milligram amount ± 10%) for ≥ 2 weeks prior to Screening Visit A and the investigator does not foresee the need to change the steroid dose during study participation. Patients should remain on this stable corticosteroid dose during study participation. Patients receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine or danazol may also be enrolled. The dosages of all these medications must be stable for at least 3 months prior to AKR-501 administration. Platelet count: Patients not receiving steroids (no steroid treatment for > 2 weeks prior to the Screening Visit A): platelets < 30,000/mm^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B) Patients receiving steroids: platelets < 50,000/mm^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B). Women of child-bearing potential must have a negative pregnancy test at Screening Visit A and Screening Visit B. (Childbearing potential is defined as any woman who has not been surgically sterilized and is premenopausal or peri-menopausal i.e., any menstrual flow within 12 months of Screening Visit A). Women of child-bearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used: condoms (male or female) with a spermicidal agent, diaphragm, or cervical cap with a spermicidal agent, IUD, hormonal contraception, abstinence). Willing and able to provide written informed consent before any study-related procedure. Exclusion Criteria: Women who are pregnant and/or lactating. Splenectomy procedure performed 4 weeks prior to AKR-501 administration. Use of the following drugs or treatments prior to Day 1: Within 3 months - Rituximab; Within 2 weeks - Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG). Participation in a clinical trial involving any investigational agent within 4 weeks of Day 1. Exposure to eltrombopag or AMG -531. Significant medical conditions or diseases as determined by the Investigator (e.g., clinically active systemic lupus erythematosus; known or suspected HIV infection; acute hepatitis or clinically active chronic hepatitis; lymphoproliferative disease; congestive heart failure). History of cardiovascular disease (e.g., angina, unstable angina, myocardial infraction, coronary artery stent placement, angioplasty, coronary artery bypass grafting). History of thromboembolic disease (e.g., transient ischemic attack [TIA], stroke [CVA], pulmonary embolism [PE]). History of deep venous thrombosis (DVT). History of lupus anticoagulant or anticardiolipin antibody syndrome or positive anti b2 glycoprotein antibody. History of any medical condition where systemic anticoagulation was required for more than 6 months. Laboratory abnormalities: Hemoglobin < 12.5 g/dL for men and < 11.5 g/dL for women. If anemia is clearly related to ITP, for example excessive blood loss, then that patient may be enrolled without the need for a waiver after discussion with the Sponsor's medical monitor White blood cell count (WBC) < lower limit of normal Absolute neutrophil count (ANC) < 1000/mm^3 Prothrombin time (PT) > 1.25 x upper limit of normal Partial thromboplastin time (PTT) > 1.25 x upper limit of normal Total bilirubin > 3 x upper normal limit Alanine transaminase (ALT) > 3 x upper normal limit Aspartate transaminase (AST) > 3 x upper normal limit Creatinine > 1.5x upper normal limit Blood urea nitrogen (BUN) > 1.5 x upper normal limit HIV positive IgM HAV positive, Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV) positive. History of, or current alcohol or drug abuse likely to interfere with ability to comply with protocol. requirements or give informed consent, as determined by the Investigator. History of, or current psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent, as determined by the Investigator. Currently taking any of the following medications: Rituximab, Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Ran Ho, MD
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Cancer Medical Center, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Concord
State/Province
California
Country
United States
Facility Name
Pacific Coast Hematology/Oncology Medical Group Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of California Irvine Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Davis, Posteraro and Wasser, MDs, LLP
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Florida Cancer Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Columbus Clinic, PC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Comprehensive Bleeding Disorders Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Cancer Care Center, Inc.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Kansas City Cancer Center, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York Presbyterian Hospital, Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Emerywood Oncology and Hematology
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
UPENN
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Cancer Centers of the Carolina
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Puget Sound Blood Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98014
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24802775
Citation
Bussel JB, Kuter DJ, Aledort LM, Kessler CM, Cuker A, Pendergrass KB, Tang S, McIntosh J. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014 Jun 19;123(25):3887-94. doi: 10.1182/blood-2013-07-514398. Epub 2014 May 6.
Results Reference
derived

Learn more about this trial

Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

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