Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

An Open-label Safety Study of S-888711

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. Identifier: NCT01129024
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : May 23, 2018
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Brief Summary:
This is a Phase 2, multicenter, open-label, extension study to evaluate the safety of S-888711 in the treatment of subjects with immune thrombocytopenia. Patients who participate in this study must have completed the Phase 2 double-blind, randomized, placebo controlled study.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: S-888711 0.5 mg tablet Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Safety Study of S-888711 in Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy
Study Start Date : March 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: S-888711 0.5 mg tablet
S-888711 0.5 mg tablet q.d.
Drug: S-888711 0.5 mg tablet
The starting dose was 0.5 mg q.d., if the platelet response was not sufficient, the dose could be increased at 0.5 mg q.d. increments up to 2.0 mg q.d.
Other Name: Lusutrombopag

Primary Outcome Measures :
  1. To evaluate the long-term safety of S-888711 [ Time Frame: From start of treatment Up to three years ]
    By measuring the number of study participants with AEs as an indication of drug safety and tolerability

Secondary Outcome Measures :
  1. To assess dose requirements for long-term platelet response [ Time Frame: Up to three years ]
    Platelet counts will be determined periodically during the study

  2. To assess durability of platelet response [ Time Frame: From start of treatment up to three years ]
    Platelet counts will be determined periodically during the study

  3. To evaluate bleeding events by World Health Organization (WHO) bleeding criteria [ Time Frame: From start of treatment up to three years ]
    Evaluation will utilize World Health Organization (WHO) bleeding criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • A signed and dated written informed consent
  • Males and females ≥ 18 years of age
  • All subjects must agree to use barrier contraception
  • Diagnosis of ITP
  • Subjects > 60 years must have had a diagnostic bone marrow aspiration
  • Relapsed persistent or chronic ITP status
  • Subjects receiving steroid therapy must be on a stable dose
  • PT and APTT within 20% of the upper limit of normal
  • Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed

Exclusion Criteria:

  • History of clinically important hemorrhagic clotting disorder
  • Females who are pregnant, lactating, or taking oral contraceptives
  • History of alcohol/drug abuse or dependence within 1 year
  • Use of the following drugs or treatment prior to Visit 1 (Day 1):

    • Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin;
    • Within 2 weeks - plasmaphoresis treatment;
    • Within 4 weeks - use of anti-platelet or anti-coagulant drugs;
    • Within 8 weeks - rituximab;
    • Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
  • History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Initial Screening
  • Splenectomy within 4 weeks prior to Initial Screening
  • Clinically significant laboratory abnormalities

    • Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP
    • Absolute neutrophil count < 1000/mm3
    • Abnormal peripheral blood smear with evidence of fibrosis confirmed by bonemarrow biopsy
    • Total bilirubin > 1.5 x upper limit of normal
    • Alanine aminotransferase (ALT) > 1.5 x upper limit of normal
    • Aspartate aminotransferase (AST) > 1.5 x upper limit of normal
    • Creatinine > 1.5 x upper limit of normal
    • Human immunodeficiency virus positive
    • Hepatitis A IgM antibody positive, hepatitis B surface antigen or hepatitis C antibody positive
  • Exposure to previous TPO mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to Initial Screening
  • Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665)
  • Exposure to an investigative medication within 4 weeks prior to the initial Screening Visit

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 identifier (NCT number): NCT01129024

Layout table for location information
United States, California
Anaheim, California, United States, 92801
Los Angeles, California, United States, 90272
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Boynton Beach, Florida, United States, 33426
Jacksonville, Florida, United States, 32207
United States, Georgia
Atlanta, Georgia, United States, 30341
Riverdale, Georgia, United States, 30274
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Missouri
Jefferson City, Missouri, United States, 65109
Kansas City, Missouri, United States, 64131
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
New York, New York, United States, 10021
New York, New York, United States, 10029
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Texas
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Layout table for investigator information
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi

Layout table for additonal information
Responsible Party: Shionogi Identifier: NCT01129024    
Other Study ID Numbers: 0914M0622
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Keywords provided by Shionogi Inc. ( Shionogi ):
Low Platelet Count
Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenia (ITP)
Thrombotic Thrombocytopenic Purpura (ITP)
Hematologic Disease
Auto-immune Thrombocytopenic Purpura
Blood Platelet Disorders
Relapsed Persistent or Chronic ITP
Additional relevant MeSH terms:
Layout table for MeSH terms
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms