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The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eltrombopag | Drug | 25, 50, 75, 100 mg tablets taken once daily orally | ||
| placebo | Drug | matched placebo taken once daily orally |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase | Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw. |
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Inclusion Criteria:
Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned
Exclusion criteria:
Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin
Subjects with a history of any one of the following:
Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder
The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294-0005 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26173631 | Derived | Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451. | |
| 25777337 | Derived | Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gomez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag: OL Phase | Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label (OL) Pre-Antiviral Treatment |
|
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| From Baseline up to Week 9 in the OL Phase |
| Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase. | From Baseline up to Week 9 in the OL Phase |
| Median Platelet Count at the Indicated Time Points During the OL Phase | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. | OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82) |
| Median Platelet Count at the Indicated Time Points During the DB Phase | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
| Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase | The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12. | From Baseline up to Week 12 |
| Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment. | From Baseline up to Week 12 |
| Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment. | From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3) |
| Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase | There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase | Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase | Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral. | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
| Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. | DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72) |
| Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS. | End of Treatment (up to Week 52); and 24-week FU (up to Week 72) |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
| Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
| Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
| Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
| Tucson |
| Arizona |
| 85750 |
| United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205-7199 | United States |
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| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Seoul | 135-710 | South Korea |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Granada | 18012 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobregat. Barcelona | 08907 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28029 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | San Sebastián | 20014 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Kaohsiung City | 80708 | Taiwan |
| GSK Investigational Site | Taichung | 407 | Taiwan |
| GSK Investigational Site | Tainan | 704 | Taiwan |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| GSK Investigational Site | Chiang Mai | 50200 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| GSK Investigational Site | Songkhla | 90110 | Thailand |
| GSK Investigational Site | Donetsk | 83114 | Ukraine |
| GSK Investigational Site | Kyiv | 01030 | Ukraine |
| GSK Investigational Site | Kyiv | 04112 | Ukraine |
| GSK Investigational Site | Vinnytsia | 21021 | Ukraine |
| GSK Investigational Site | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
| GSK Investigational Site | London | NW3 2QG | United Kingdom |
| GSK Investigational Site | London | W2 1NY | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 8DH | United Kingdom |
| 24126097 | Derived | Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12. |
| FG001 | Placebo+Antiviral Therapy: DB Phase | Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). |
| FG002 | Eltrombopag+Antiviral Therapy: DB Phase | Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). |
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| NOT COMPLETED |
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| Double-blind (DB) Antiviral Treatment |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo+Antiviral Therapy: DB Phase | Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). |
| BG001 | Eltrombopag+Antiviral Therapy: DB Phase | Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age Continuous | Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all randomized participants in the Double-blind (DB) Phase of the study. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all randomized participants in the Double-blind (DB) Phase of the study. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. | Number | participants |
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| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) | Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. The HCV is a small, enveloped, single-stranded, positive-sense ribonucleic acid (RNA) virus. There are seven major genotypes of HCV, which are indicated numerically from Genotype 1 to 7. | Number | participants |
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| Number of participants categorized into the indicated Child-Pugh (CP) Class | The CP score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5-6 = Class A (mild); 7-9 = Class B (moderate); >=10 = Class C (severe). | Number | participants |
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| Number of participants with or without previous interferon (IFN) use | Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. Participants at Baseline were classified as not having used IFN previously (Naïve) or having used IFN previously (Experienced). | Number | participants |
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| Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score | FibroSURE is a noninvasive blood test that combines the quantitative results of 6 serum biochemical markers (α2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, γ-glutamyl transpeptidase [GGT], and ALT) with a participant's age and gender to generate a measure of liver fibrosis/cirrhosis and necroinflammatory activity. It provides a numerical quantitative estimate of liver fibrosis ranging from 0.00 to 1.00, corresponding to the Metavir scoring system of stages F0 to F4 (F0, no fibrosis [F]; F1, portal F; F2, bridging F with few septa; F3, bridging F with many septa; F4=cirrhosis). | Number | participants |
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| Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT) | Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. The normal range of ALT is 0 to 48 International Units per Liter (IU/L). | Number | participants |
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| Baseline HCV Ribonucleic Acid (RNA) | Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. HCV RNA was assessed at baseline of the DB Phase. Data are missing for one participant in the Eltrombopag+Antiviral Therapy treatment group. | Mean | Standard Deviation | International Units per milliliter |
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| Baseline Platelet Count | Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. Platelet count eligibility was confirmed at the Baseline visit, prior to administration of eltrombopag, and was defined as the average of the screening and baseline counts, which must be <75 Gi/L. | Mean | Standard Deviation | Giga (10^9) cells per liter (Gi/L) |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase. | Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase | Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw. | Safety Population: all participants who had received study drug in the OL Phase | Posted | Number | participants | From Baseline up to Week 9 in the OL Phase |
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| Secondary | Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase. | Safety Population. Participants with a platelet count >=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed. | Posted | Number | participants | From Baseline up to Week 9 in the OL Phase |
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| Secondary | Median Platelet Count at the Indicated Time Points During the OL Phase | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Median | Full Range | Gi/L | OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82) |
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| Secondary | Median Platelet Count at the Indicated Time Points During the DB Phase | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. | Posted | Median | Full Range | Gi/L | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
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| Secondary | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase | The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L. | ITT Population | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12. | ITT Population | Posted | Number | participants | From Baseline up to Week 12 |
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| Secondary | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment. | ITT Population | Posted | Number | participants | From Baseline up to Week 12 |
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| Secondary | Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment. | ITT Population | Posted | Number | participants | From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin. | ITT Population | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction. | ITT Population. Only those participants with dose reductions were analyzed. | Posted | Mean | Standard Deviation | weeks | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved. | ITT Population. One participant could have had more than one dose reduction. | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3. | ITT Population | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase | There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0. | Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase | Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | Safety DB Population: all randomized participants who had received study drug in the DB Phase | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | Safety DB Population | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase | Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral. | Safety DB Population | Posted | Number | participants | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) |
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| Secondary | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given). | Posted | Number | participants | DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72) |
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| Secondary | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS. | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Number | participants | End of Treatment (up to Week 52); and 24-week FU (up to Week 72) |
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| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
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| Secondary | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | beats per minute | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
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| Secondary | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Kilograms (kg) | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
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| Secondary | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Kilograms per meters squared (kg/m^2) | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) |
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Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 72).
In the study, AEs were collected during the Open-Label (OL) Pre-Antiviral Treatment Phase and the Double-Blind (DB) Phase, which included antiviral therapy and a 6-month post-therapy follow-up. Data for SAEs and AEs are presented for the Safety Population, comprised of all randomized participants who received the study drug.
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 | Eltrombopag: OL Phase | Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits. | 8 | 715 | 49 | 715 | ||
| EG001 | Placebo+Antiviral Therapy: DB Phase | Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). | 35 | 232 | 219 | 232 | ||
| EG002 | Eltrombopag+Antiviral Therapy: DB Phase | Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). | 89 | 449 | 424 | 449 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal Varices Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric Varices Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peptic Ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Varices Oesophageal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Peritonitis Bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhea Infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Disseminated Tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis Cryptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Prostatic Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Renal Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acinetobacter Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis Perforated | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hemolytic Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatitis Alcoholic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatorenal Syndrome | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Portal Vein Thrombosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Edema Peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Multi-organ Failure | General disorders | MedDRA | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Brain Edema | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vocal Cord Paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ruptured Cerebral Aneurysm | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract Nuclear | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye Disorder | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal Vein Occlusion | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cystitis Ulcerative | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urethral Polyp | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea Exertional | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb Traumatic Amputation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic Lung Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Retinal Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Bleeding Varicose Vein | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Varicose Vein | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Juvenile Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Epidermolysis Bullosa | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Deafness Neurosensory | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Alcohol Use | Social circumstances | MedDRA | Systematic Assessment |
| |
| Portal Shunt | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Edema Peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Hemoglobin Decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
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 |
|---|---|
| D019698 | Hepatitis C, Chronic |
| C537560 | Jacobs syndrome |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Protocol Violation |
|
| Physician Decision |
|
| Male |
|
| American Indian/Alaska Native |
|
| Central/South Asian Heritage |
|
| Japanese/East Asian Heritage/South East Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Asian and White |
|
| Native Hawaiian/ Other Pacific Islander and White |
|
| Genotype 2 |
|
| Genotype 3 |
|
| Genotype 4 |
|
| Genotype 5 |
|
| Genotype 6 |
|
| Genotype 7 |
|
| Missing Data |
|
| Class B |
|
| Class C |
|
| Missing Data |
|
| Experienced |
|
| Score: F3/F4 |
|
| Missing |
|
| Elevated |
|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Eltrombopag+Antiviral Therapy: DB Phase |
Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). |
|
|
Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
|
|
|
|
|
|
| Eltrombopag+Antiviral Therapy: DB Phase |
Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). |
|
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