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This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB-497115-GR group | Experimental | Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg. |
|
| placebo group | Placebo Comparator | Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-497115-GR 12.5mg | Drug | SB-497115-GR 12.5mg tablet once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders at Week 6 | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). | Week 6 |
| 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 | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6 | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits. | Weeks 2 through 6 |
| Percentage of Responders at Each Visit |
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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
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)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Gifu | 503-8502 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22409309 | Derived | Tomiyama Y, Miyakawa Y, Okamoto S, Katsutani S, Kimura A, Okoshi Y, Ninomiya H, Kosugi H, Nomura S, Ozaki K, Ikeda Y, Hattori T, Katsura K, Kanakura Y. A lower starting dose of eltrombopag is efficacious in Japanese patients with previously treated chronic immune thrombocytopenia. J Thromb Haemost. 2012 May;10(5):799-806. doi: 10.1111/j.1538-7836.2012.04695.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7 |
| FG001 | SB-497115-GR, Double-blind |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
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| SB-497115-GR 25mg |
| Drug |
SB-497115-GR 25mg tablet once a day |
|
| SB-497115-GR 12.5mg matching placebo | Drug | SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day |
|
| SB-497115-GR 50 mg | Drug | SB-497115-GR 25mg tablet x2 once a day |
|
|
A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). |
| Days 8, 15, 22, 29, 36, and 43 |
| Mean Platelet Count at Each Visit | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. | Baseline and Days 8, 15, 22, 29, 36, and 43 |
| Mean Change From Baseline in Platelet Counts at Each Visit | Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value | Baseline and Days 8, 15, 22, 29, 36, and 43 |
| Percentage of Participants With Bleeding Episodes Since the Last Visit | When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). | Days 1, 8, 15, 22, 29, 36, and 43 |
| Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. | Baseline and Days 8, 15, 22, 29, 36, and 43 |
| Percentage of Responders at Each Visit | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
| Mean Platelet Counts of Participants at Each Visit | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
| Mean Change From Baseline in Platelet Counts at Each Visit | Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
| Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter | Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Weeks 1 through 26 |
| Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter | Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Weeks 1 through 26 |
| Percentage of Participants With Bleeding Episode Since the Last Visit | When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
| Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline | ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Baseline through Week 26 |
| Percentage of Participants Who Received Rescue Treatment for ITP | Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Weeks 1 through 26 |
| Mean Number of Days of Concomitant ITP Medication Use Per Month | Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Weeks 1 through 26 |
| Pharmacokinetics of SB-497115-GR, Cmax | Cmax: Peak plasma concentration of SB-497115 | Week 9 or 10 |
| Pharmacokinetics of SB-497115-GR, Tmax | tmax: Time when Cmax was achieved | Week 9 or 10 |
| Pharmacokinetics of SB-497115, t1/2 | t1/2 is half life based on the terminal phase | Week 9 or 10 |
| Pharmacokinetics of SB-497115-GR, Lambda z | Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve. | Week 9 or 10 |
| Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24 | AUC is area under a concentration vs. time curve. AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation: AUC0-24= AUClast + Clast × (1 - e-λz × [24-tlast])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation. | Week 9 or 10 |
| Pharmacokinetics of SB-497115-GR, CL/F | CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. | Week 9 or 10 |
| Pharmacokinetics of SB-497115-GR, Vz/F | VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed. | Week 9 or 10 |
| Hiroshima |
| 734-8551 |
| Japan |
| GSK Investigational Site | Ibaraki | 305-8576 | Japan |
| GSK Investigational Site | Osaka | 565-0871 | Japan |
| GSK Investigational Site | Osaka | 596-8501 | Japan |
| GSK Investigational Site | Tochigi | 329-0498 | Japan |
| GSK Investigational Site | Tokyo | 160-8582 | Japan |
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7. |
| FG002 | SB-497115-GR, Open-label | All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count. |
| COMPLETED |
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| NOT COMPLETED |
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| Open-Label Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | SB-497115-GR | SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7. |
| BG001 | Placebo | Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Responders at Week 6 | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). | Full Analysis Set: all randomized participants, with the exception of (1) those who did not receive any dose of study medication and (2) those with no valid platelet count measurements on therapy | Posted | Number | Participants | Week 6 |
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| Secondary | Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6 | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits. | Full Analysis Set | Posted | Number | Participants | Weeks 2 through 6 |
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| Primary | 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 | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Responders at Each Visit | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). | Full Analysis Set | Posted | Number | Percentage of responders | Days 8, 15, 22, 29, 36, and 43 |
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| Secondary | Mean Platelet Count at Each Visit | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. | Full Analysis Set | Posted | Mean | Standard Deviation | 10^9/Liter | Baseline and Days 8, 15, 22, 29, 36, and 43 |
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| Secondary | Mean Change From Baseline in Platelet Counts at Each Visit | Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value | Full Analysis Set | Posted | Mean | Standard Deviation | 10^9/Liter | Baseline and Days 8, 15, 22, 29, 36, and 43 |
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| Secondary | Percentage of Participants With Bleeding Episodes Since the Last Visit | When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). | Full Analysis Set | Posted | Number | Percentage of participants | Days 1, 8, 15, 22, 29, 36, and 43 |
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| Secondary | Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. | Full Analysis Set | Posted | Number | Participants | Baseline and Days 8, 15, 22, 29, 36, and 43 |
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| Secondary | Percentage of Responders at Each Visit | A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Number | Percentage of responders | Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
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| Secondary | Mean Platelet Counts of Participants at Each Visit | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Mean | Standard Deviation | 10^9/Liter | Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
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| Secondary | Mean Change From Baseline in Platelet Counts at Each Visit | Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Mean | Standard Deviation | 10^9/Liter | Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
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| Secondary | Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter | Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Mean | Standard Deviation | Days | Weeks 1 through 26 |
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| Secondary | Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter | Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Mean | Standard Deviation | Days | Weeks 1 through 26 |
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| Secondary | Percentage of Participants With Bleeding Episode Since the Last Visit | When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Number | Percentage of participants | Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 |
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| Secondary | Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline | ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set. Four participants in the Full Analysis Set did not have concomitant ITP medication at Baseline. | Posted | Number | Percentage of participants | Baseline through Week 26 |
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| Secondary | Percentage of Participants Who Received Rescue Treatment for ITP | Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Number | Percentage of participants | Weeks 1 through 26 |
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| Secondary | Mean Number of Days of Concomitant ITP Medication Use Per Month | Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. | Full Analysis Set | Posted | Mean | Standard Deviation | Days | Weeks 1 through 26 |
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| Secondary | Pharmacokinetics of SB-497115-GR, Cmax | Cmax: Peak plasma concentration of SB-497115 | Pharmacokinetic (PK) Population: all participants with valid PK data following SB-497115-GR treatment | Posted | Mean | Standard Deviation | ng/mL (nanograms/milliliter) | Week 9 or 10 |
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| Secondary | Pharmacokinetics of SB-497115-GR, Tmax | tmax: Time when Cmax was achieved | PK Population | Posted | Median | Full Range | Hours | Week 9 or 10 |
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| Secondary | Pharmacokinetics of SB-497115, t1/2 | t1/2 is half life based on the terminal phase | PK Population. Data from one participant were abnormal; this participant was excluded from this analysis. | Posted | Mean | Standard Deviation | Hours | Week 9 or 10 |
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| Secondary | Pharmacokinetics of SB-497115-GR, Lambda z | Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve. | PK Population. Data from one participant were abnormal; this participant was excluded from this analysis. | Posted | Mean | Standard Deviation | 1/hour | Week 9 or 10 |
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| Secondary | Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24 | AUC is area under a concentration vs. time curve. AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation: AUC0-24= AUClast + Clast × (1 - e-λz × [24-tlast])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation. | PK Population. Data from one participant were abnormal; this participant was excluded from this analysis. | Posted | Mean | Standard Deviation | hr*ng/mL | Week 9 or 10 |
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| Secondary | Pharmacokinetics of SB-497115-GR, CL/F | CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. | PK Population. Data from one participant were abnormal; this participant was excluded from this analysis. | Posted | Mean | Standard Deviation | L/hr (Liters/hour) | Week 9 or 10 |
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| Secondary | Pharmacokinetics of SB-497115-GR, Vz/F | VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed. | PK Population. Data from one participant were abnormal; this participant was excluded from this analysis. | Posted | Mean | Standard Deviation | Liters | Week 9 or 10 |
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AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Short-Term (Double-Blind) Phase | Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7. | 0 | 8 | 2 | 8 | ||
| EG001 | SB-497115-GR Short-Term (Double-Blind) Phase | SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7. | 1 | 15 | 7 | 15 | ||
| EG002 | SB-497115-GR Long-Term Phase | All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count | 6 | 23 | 19 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Aspartate aminotransferase increased | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Platelet count increased | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Conjunctival hemorrhage | Eye disorders | MedDRA | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Cataract | Eye disorders |
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| Blood alkaline phosphatase increased | Investigations |
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| Blood creatine phosphokinase decresed | Investigations |
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| Pharyngitis | Infections and infestations |
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| Hypermagnesemia | Metabolism and nutrition disorders |
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| Hypophosphatemia | Metabolism and nutrition disorders |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
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| Palpitations | Cardiac disorders |
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| Cystitis-like symptom | Renal and urinary disorders |
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| Dysmenorrhoea | Renal and urinary disorders |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| C537560 | Jacobs syndrome |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
Not provided
Not provided
Not provided
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