A Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered to Adult Subjects With Immune Thrombocytopenia (ITP)
This study has been terminated.
(The study objectives became unachievable as a result of the termination of 0913M0621)
Sponsor:
Shionogi
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT01054443
First received: January 20, 2010
Last updated: September 13, 2011
Last verified: July 2011
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Purpose
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of S-888711 in the treatment of subjects with immune thrombocytopenia. Eligible subjects will be randomized into one of four treatment groups to receive S-888711 0.5 mg, 0.75 mg, or 1.0 mg or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Immune Thrombocytopenia (ITP) |
Drug: placebo to S-888711 Drug: S-888711 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered Once-daily for 42 Days to Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy |
Resource links provided by NLM:
Further study details as provided by Shionogi Inc.:
Primary Outcome Measures:
- The primary efficacy endpoint is the proportion of responder subjects in each treatment group [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]The responders were subjects with 1) achieved a platelet count of ≥ 50, 000/µL after 6 weeks of dosing 2) prematurely withdrawn due to a platelet count > 400,000/ µL prior to Day 42
Secondary Outcome Measures:
- Safety of S-888711 [ Time Frame: 6-weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetics (PK) profile of S-888711 using sparse PK sampling [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
- PK profile of S-888711 using serial PK sampling in a selected subset of subjects [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
- PK/PD relationship of S-888711 with respect to platelet count [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
- Impact of S-888711 on the incidence and severity of bleeding [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
- Pharmacodynamic (PD) effect of S-888711 on platelet count and markers of platelet function, such as endogeneous thrombopoietin (TPO) [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: placebo to S-888711
Tablet
|
| Experimental: 0.5 mg |
Drug: S-888711
Tablet
|
| Experimental: 0.75 mg |
Drug: S-888711
Tablet
|
| Experimental: 1.0 mg |
Drug: S-888711
Tablet
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs
- 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. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1)
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 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
- Within 8 weeks - rituximab
- Within 2 weeks - platelet transfusions or plasmapheresis treatment
- Within 4 weeks - use of anti-platelet or anti-coagulant drugs
- Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin
- History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Screening
- Splenectomy within 4 weeks prior to 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
- 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 (HIV) positive
- Hepatitis A IgM antibody (IgM HAV) positive, hepatitis B surface antigen (HbsAg) or hepatitis C antibody (HCV) positive
- Thyroid stimulating hormone (TSH) > 1.5 x upper limit of normal
- Free thyroxine (T4) > 1.5 x upper limit of normal
- Exposure to previous TPO mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to Screening
- Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665)
- Exposure to an investigative medication within the past 30 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054443
Locations
| United States, California | |
| Investigator | |
| Anaheim, California, United States, 92801 | |
| Investigator | |
| Los Angeles, California, United States, 90272 | |
| United States, District of Columbia | |
| Investigator | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Investigator | |
| Boynton Beach, Florida, United States, 33426 | |
| Investigator | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| Investigator | |
| Atlanta, Georgia, United States, 30341 | |
| Investigator | |
| Riverdale, Georgia, United States, 30274 | |
| United States, Louisiana | |
| Investigator | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| Investigator | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Massachusetts | |
| Investigator | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Missouri | |
| Investigator | |
| Jefferson City, Missouri, United States, 65109 | |
| Investigator | |
| Kansas City, Missouri, United States, 64131 | |
| United States, New Jersey | |
| Investigator | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| Investigator | |
| New York, New York, United States, 10029 | |
| Investigator | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Investigator | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| Investigator | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Investigator | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Investigator | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Shionogi
Investigators
| Study Director: | Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi |
More Information
No publications provided
| Responsible Party: | Shionogi Clinical Trials Administrator, Shionogi |
| ClinicalTrials.gov Identifier: | NCT01054443 History of Changes |
| Other Study ID Numbers: | 0913M0621 |
| Study First Received: | January 20, 2010 |
| Last Updated: | September 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Shionogi Inc.:
|
Blood Platelet Disorders Immune Thrombocytopenia (ITP) Low Platelet Count Thrombocytopaenia S-888711 Splenectomy |
Thrombopoiesis Hematologic Disease Auto-immune thrombocytopenic Purpura Relapsed Persistent or Chronic ITP Idiopathic Thrombocytopenic Purpura Thrombotic Thrombocytopenic Purpura (TTP) |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013