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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00540423 |
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Date of registration:
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05/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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Scientific title:
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Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00540423 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria.
At Screening (Week -4 or -3)
- Diagnosed with ITP for at least 6 months prior to screening.
- Have a platelet count of <30,000/µL.
- Previously treated refractory or relapsed patients who have failed to achieve a
platelet count of >=30,000/µL despite one or more prior therapies (either H. pylori
eradication, corticosteroids, splenectomy, danazol or immunosuppressive drugs). (Note:
Previous H. pylori eradication must have been completed at least 3 months prior to
screening and clearly be ineffective).
- Previous treatment for ITP with splenectomy, rituximab, and cyclophosphamide must have
been completed at Week -4 and clearly be ineffective.
- Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be
receiving a dose that has been stable for at least 3 months prior to screening."
- A complete blood count (CBC) within the reference range, with the following exceptions
1. Hemoglobin: females >=9g/dL and males >=10g/dL are eligible for inclusion if
hemorrhage is present.
2. Neutrophil count >=1,500/µL (1.5x109/L) is required for inclusion.
- The following clinical chemistries MUST NOT exceed 1.2 times the normal reference
range:creatinine, ALT, AST, total bilirubin and alkaline phosphatase.
- Albumin must be within 80 to 120% of normal range.
- Subject is >=20 years old.
- Female subjects must either be:
- of non-childbearing potential (bilateral tubal ligation or post-menopausal), or
- of childbearing potential and have a negative pregnancy test and agree to use
contraceptive methods specified in the GSK List of Highly Effective Methods for
Avoidance of Pregnancy
- Hospitalization status: No restriction.
- Gender: No restriction.
- Subject has signed and dated written informed consent. At Randomization (Week 0)
- Have a platelet count of <30,000/µL.
- Previous therapy for ITP with immunoglobulins (IVIG and anti-D) and vincristine must
have been completed at least 2 weeks prior to randomization and the platelet count
must show a clear downward trend after the last treatment with immunoglobulins.
- Subjects treated with corticosteroids or azathioprine must be receiving a dose that
has been stable for at least 4 weeks prior to randomization.
- Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must
not exceed 1.2 times the upper limit of the normal range with no history of
hypercoagulable state. (Note: These parameters will be measured at screening or at
randomization.)
- CBC and clinical chemistries fulfill the same criteria as those at screening.
- Reticulocyte count within the reference range or elevated in case of bleeding. (Note:
This parameter will be measured at screening or at randomization.)
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in the study.
At Screening (Week -4 or -3)
- Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic
ITP. (Note: ""Severe"" is defined as >=Grade 3 as a rule according to the
""Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80,
dated 29 June 1992) (Appendix X).)
- History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial
infarction, deep vein thrombosis) within the last 1 year.
- History of drug/alcohol abuse or dependence within 1 year prior to screening.
- Previous treatment with SB-497115-GR.
- Suspected blood disorder other than ITP.
- Suspected platelet aggregation abnormality.
- Suspected cyclic thrombocytopenia
- Current or history of HIV infection or hepatitis B virus or hepatitis C virus
infections.
- Current or history of malignancy (Exception: Subjects with a history of completely
resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are
eligible).
- Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate
pregnancy during the study period.
- Subjects who are deemed unsuitable for the study by the investigator (or sub
investigator).
- Subjects who are participating in any other clinical trials at present or ones who
previously participated in clinical trials and were treated with investigational
products within last one month." At Randomization (Week 0)
- Subject wishes to withdraw consent.
- Subject is lost to follow-up.
- Subject has consumed anti-platelet agents (e.g., ticlopidine and aspirin),
anticoagulants, or non-steroidal anti-inflammatory drugs (NSAIDs) for 7days prior to
the first dose of study medication and will require these medications during the study
period.
- Subjects who are deemed unsuitable for the study by the investigator (or sub
investigator).
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Idiopathic Thrombocytopenic Purpura
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Purpura, Thrombocytopenic, Idiopathic
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Intervention(s)
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Drug: SB-497115-GR 12.5mg
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Drug: SB-497115-GR 25mg
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Drug: SB-497115-GR 12.5mg matching placebo
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Drug: SB-497115-GR 50 mg
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Primary Outcome(s)
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Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders
[Time Frame: Week 26]
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Number of Responders at Week 6
[Time Frame: Week 6]
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Secondary Outcome(s)
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Mean Change From Baseline in Platelet Counts at Each Visit
[Time Frame: Baseline and Days 8, 15, 22, 29, 36, and 43]
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Pharmacokinetics of SB-497115-GR, CL/F
[Time Frame: Week 9 or 10]
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Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter
[Time Frame: Weeks 1 through 26]
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Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6
[Time Frame: Weeks 2 through 6]
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Mean Platelet Count at Each Visit
[Time Frame: Baseline and Days 8, 15, 22, 29, 36, and 43]
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Mean Platelet Counts of Participants at Each Visit
[Time Frame: Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26]
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Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline
[Time Frame: Baseline through Week 26]
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Percentage of Participants With Bleeding Episodes Since the Last Visit
[Time Frame: Days 1, 8, 15, 22, 29, 36, and 43]
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Percentage of Responders at Each Visit
[Time Frame: Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26]
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Percentage of Participants Who Received Rescue Treatment for ITP
[Time Frame: Weeks 1 through 26]
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Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter
[Time Frame: Weeks 1 through 26]
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Mean Number of Days of Concomitant ITP Medication Use Per Month
[Time Frame: Weeks 1 through 26]
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Pharmacokinetics of SB-497115, t1/2
[Time Frame: Week 9 or 10]
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Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24
[Time Frame: Week 9 or 10]
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Pharmacokinetics of SB-497115-GR, Cmax
[Time Frame: Week 9 or 10]
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Percentage of Participants With Bleeding Episode Since the Last Visit
[Time Frame: Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26]
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Pharmacokinetics of SB-497115-GR, Lambda z
[Time Frame: Week 9 or 10]
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Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
[Time Frame: Baseline and Days 8, 15, 22, 29, 36, and 43]
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Pharmacokinetics of SB-497115-GR, Tmax
[Time Frame: Week 9 or 10]
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Pharmacokinetics of SB-497115-GR, Vz/F
[Time Frame: Week 9 or 10]
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Mean Change From Baseline in Platelet Counts at Each Visit
[Time Frame: Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26]
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Percentage of Responders at Each Visit
[Time Frame: Days 8, 15, 22, 29, 36, and 43]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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