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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).


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic

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Trial Information

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).


This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging,
parallel-group study. The PK and PK/PD relationship of AKR-501 will also be studied.
Approximately 65 eligible patients 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 AKR-501 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each AKR-501 dosing
group will consist of 15 patients while the placebo group will consist of 5 patients. All
study patients will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy,
and (Days 7, 14, 21, and 28) AKR-501 pharmacokinetics 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, patients who complete 28±1 days of study dosing will be
assessed for eligibility to enroll into the rollover Study 501-CL-004 based on this visit.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Assess response to therapy on Day 28

Outcome Time Frame:

Days 3, 5, 7, 14, 21, 28 and 42

Safety Issue:

No

Principal Investigator

Pei-Ran Ho, MD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AKR-501-CL-003

NCT ID:

NCT00441090

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Chronic Idiopathic Thrombocytopenic Purpura
  • Purpura, Thrombocytopenic, Idiopathic
  • Chronic Idiopathic Thrombocytopenic Purpura
  • Idiopathic Thrombocytopenic Purpura
  • ITP
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombocytopenic, Idiopathic

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Capitol Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
Mount Sinai Medical CenterNew York, New York  10029
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Georgetown UniversityWashington, District of Columbia  20007-2197
Bay Area Cancer Research Group, LLCConcord, California  94520
Florida Cancer InstituteNew Port Richey, Florida  34652
New York Presbyterian Hospital, Weill Medical College of Cornell UniversityNew York, New York  10021
Cancer Care Center, Inc.New Albany, Indiana  47150
Comprehensive Bleeding Disorders CenterPeoria, Illinois  61614
Pacific Cancer Medical Center, IncAnaheim, California  92801
Cancer Centers of the CarolinaGreenville, South Carolina  29615
Columbus Clinic, PCColumbus, Georgia  31901
Pacific Coast Hematology/Oncology Medical Group Inc.Fountain Valley, California  92708
University of California Irvine Cancer CenterOrange, California  92618
Davis, Posteraro and Wasser, MDs, LLPManchester, Connecticut  06105
John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and OncologyChicago, Illinois  60612
Kansas City Cancer Center, LLCKansas City, Missouri  64131
UMDNJ - Robert Wood Johnson Medical SchoolNews Brunswick, New Jersey  08901
Emerywood Oncology and HematologyHigh Point, North Carolina  27262
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister CenterColumbus, Ohio  43219
UPENNPhiladelphia, Pennsylvania  19104
Puget Sound Blood CenterSeattle, Washington  98014