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Study terminated by sponsor (29 Sep 2010). Subjects eligible to continue mepolizumab treatment were transferred into the compassionate use program (MHE104317)
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This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mepolizumab | Experimental | 750mg Intravenous, monthly and individual dosing schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mepolizumab | Drug | Study Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) During the Treatment Phase | An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE | From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years) |
| Number of Participants With Any Adverse Event (AE) During the Follow-up Phase | An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE | From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study | Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis. | up to approximately 6 years |
| Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Diego | California | 92103 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 100901 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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This study was open-label extension to previous Study MHE100185 (NCT00086658). A total of seventy-eight participants participated in this study. Of these, 38 participants previously received placebo in Study MHE100185 and 40 participants previously received mepolizumab in Study MHE100185.
Participants (par.) who completed 9 months of treatment or withdrew from Study MHE100185 after receiving >=2 infusions of study medication were enrolled in this open label extension study. Par. with daily dose of prednisone >10 milligrams (mg) or <=10 mg at the end of Study MHE100185 were enrolled in Stage 1 or Stage 2 of this study, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepolizumab 750 mg | Participants received mepolizumab 750 mg by intravenous (IV) infusion monthly in Stage 1 along with concomitant hypereosinophilic syndrome (HES)-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint. |
| up to approximately 6 years |
| For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months). | up to approximately 6 years |
| For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks). | up to approximately 6 years |
| For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months; | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months). | up to approximately 6 years |
| For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months) | up to approximately 6 years |
| Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3 | Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included. | up to approximately 6 years |
| Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2 | The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency. | up to approximately 6 years |
| Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score. | Baseline and up to approximately 6 years |
| Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score.. | Baseline and up to approximately 6 years |
| Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline. | Baseline and up to approximately 6 years |
| Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline. | Baseline and up to approximately 6 years |
| Denver |
| Colorado |
| 80206 |
| United States |
| GSK Investigational Site | Bethesda | Maryland | 20892 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Richmond | Virginia | 23298 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53705 | United States |
| GSK Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| GSK Investigational Site | West Perth | Western Australia | 6005 | Australia |
| GSK Investigational Site | Brussels | 1070 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5V 2T3 | Canada |
| GSK Investigational Site | Lille | 59000 | France |
| GSK Investigational Site | Suresnes | 92150 | France |
| GSK Investigational Site | Munich | Bavaria | 80802 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | 24576 | Germany |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40138 | Italy |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100901 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100901 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100901 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100901 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100901 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100901 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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|
| Stage 2 |
|
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| Stage 3 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepolizumab 750 mg | Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| 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 Participants With Any Adverse Event (AE) During the Treatment Phase | An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE | Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of mepolizumab in this study. | Posted | Number | Participants | From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Any Adverse Event (AE) During the Follow-up Phase | An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE | Follow-up Population: subset of the modified ITT Population who had evidence of being in the study > length of dosing cycle + 7 days after the date of their last dose of study medication and up to and including 97 days after their last dose date. | Posted | Number | Participants | From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study | Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis. | ITT Population | Posted | Number | Participants | up to approximately 6 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study | The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint. | ITT Population | Posted | Number | Participants | up to approximately 6 years |
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| Secondary | For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months). | ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level <=10 mg were analyzed. | Posted | Number | Participants | up to approximately 6 years |
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| Secondary | For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks). | ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level >10 mg were analyzed. | Posted | Number | Participants | up to approximately 6 years |
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| Secondary | For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months; | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months). | ITT Population. Only those participants who entered Stage 2 from study MHE100185 with a prednisone level of <=10 mg prednisone were analyzed. | Posted | Number | Participants | up to approximately 6 years |
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| Secondary | For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months | Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months) | ITT Population. Only those participants who entered Stage 1 from study MHE100185 with >10 mg prednisone were analyzed. | Posted | Number | Participants | up to approximately 6 years |
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| Secondary | Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3 | Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Cell/uL | up to approximately 6 years |
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| Secondary | Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2 | The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency. | ITT Population. Only those participants available at end of Stage 2 were included. | Posted | Number | Participants | up to approximately 6 years |
|
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| Secondary | Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Scores on the scale | Baseline and up to approximately 6 years |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score.. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to approximately 6 years |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Scores on the scale | Baseline and up to approximately 6 years |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter | The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to approximately 6 years |
|
On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from from the first dose of study medication up to 7 days after the last dose (up to approximately 6 years).
SAEs and non-serious AEs were collected in members of the Intent to treat (ITT)population, comprised of all enrolled participants who received at least one dose of mepolizumab in this study
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 | Mepolizumab 750 mg | Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring. | 40 | 78 | 72 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Dyspnoea | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis eosinophilic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Motor neurone disease | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Radiculitis brachial | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hypereosinophilic syndrome | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Angioimmunoblastic T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eosinophilic cellulitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| T-lymphocyte count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Self-injurious ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA r | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | Neck pain | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypereosinophilic syndrome | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular 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 |
|---|---|
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
| ID | Term |
|---|---|
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C434107 | mepolizumab |
Not provided
Not provided
Not provided
| Pregnancy |
|
| Sponsor Terminated Study |
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| Lost to Follow-up |
|
| Sponsor Terminated Study |
|
| Lost to Follow-up |
|
| East and South East Asian |
|
| South Asian |
|
| White/Caucasian |
|
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| Units | Counts |
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| Participants |
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