Trial · NCT00097370

Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome

NCT00097370, Phase 3, Terminated, GlaxoSmithKline; results first posted 2015-12-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome. Trials, record NCT00097370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00097370

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome
NCT number: NCT00097370
Status: Terminated
Phases: Phase 3
Enrollment: 78 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Hypereosinophilic Syndrome
Interventions: mepolizumab
First posted: 2004-11-23
Last updated: 2017-07-07
Results first posted: 2015-12-15

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Any Adverse Event (AE) During the Treatment Phase	From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)	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
Primary	Number of Participants With Any Adverse Event (AE) During the Follow-up Phase	From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)	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
Secondary	Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study	up to approximately 6 years	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.
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	up to approximately 6 years	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.
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	up to approximately 6 years	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).
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	up to approximately 6 years	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).
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;	up to approximately 6 years	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).
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	up to approximately 6 years	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)
Secondary	Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3	up to approximately 6 years	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.
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	up to approximately 6 years	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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Any Adverse Event (AE) During the Treatment Phase	From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)	Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of mepolizumab in this study.	Participants	NUMBER
PRIMARY	Number of Participants With Any Adverse Event (AE) During the Follow-up Phase	From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)	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.	Participants	NUMBER
SECONDARY	Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study	up to approximately 6 years	ITT Population	Participants	NUMBER
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	up to approximately 6 years	ITT Population	Participants	NUMBER
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	up to approximately 6 years	ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level \<=10 mg were analyzed.	Participants	NUMBER
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	up to approximately 6 years	ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level \>10 mg were analyzed.	Participants	NUMBER
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;	up to approximately 6 years	ITT Population. Only those participants who entered Stage 2 from study MHE100185 with a prednisone level of \<=10 mg prednisone were analyzed.	Participants	NUMBER
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	up to approximately 6 years	ITT Population. Only those participants who entered Stage 1 from study MHE100185 with \>10 mg prednisone were analyzed.	Participants	NUMBER
SECONDARY	Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3	up to approximately 6 years	ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).	Cell/uL	MEAN
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	up to approximately 6 years	ITT Population. Only those participants available at end of Stage 2 were included.	Participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group83

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Any Adverse Event (AE) During the Treatment Phase	Mepolizumab 750 mg		76		Participants
Number of Participants With Any Adverse Event (AE) During the Follow-up Phase	Mepolizumab 750 mg		3		Participants
Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study	Mepolizumab 750 mg		62		Participants
Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study	Mepolizumab 750 mg		46		Participants
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	Mepolizumab 750 mg		39		Participants
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	Mepolizumab 750 mg		5		Participants
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;	Mepolizumab 750 mg		43		Participants
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	Mepolizumab 750 mg		22		Participants
Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3	Mepolizumab 750 mg	MHE100185 Baseline; n=78	456.2	Standard Deviation 713.81	Cell/uL
Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3	Mepolizumab 750 mg	MHE100901 Baseline, n=65	467.2	Standard Deviation 719.66	Cell/uL

1 to 10 of 83Source ClinicalTrials.gov

See all 83 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Stage 1	STARTED	Mepolizumab 750 mg	37
Stage 1	COMPLETED	Mepolizumab 750 mg	31
Stage 1	NOT COMPLETED	Mepolizumab 750 mg	6
Stage 2	STARTED	Mepolizumab 750 mg	72
Stage 2	COMPLETED	Mepolizumab 750 mg	59
Stage 2	NOT COMPLETED	Mepolizumab 750 mg	13
Stage 3	STARTED	Mepolizumab 750 mg	59
Stage 3	COMPLETED	Mepolizumab 750 mg	0
Stage 3	NOT COMPLETED	Mepolizumab 750 mg	59

Source ClinicalTrials.gov

Adverse events159

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	Mepolizumab 750 mg	22	78
other	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Mepolizumab 750 mg	22	78
other	Bronchitis	Respiratory, thoracic and mediastinal disorders	Mepolizumab 750 mg	21	78
other	Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	Mepolizumab 750 mg	18	78
other	Rhinitis	Infections and infestations	Mepolizumab 750 mg	9	78
other	Ear infection	Infections and infestations	Mepolizumab 750 mg	7	78
other	Gastroenteritis	Infections and infestations	Mepolizumab 750 mg	6	78
other	Pharyngitis	Infections and infestations	Mepolizumab 750 mg	6	78
other	Urinary tract infection	Infections and infestations	Mepolizumab 750 mg	6	78
other	Cystitis	Infections and infestations	Mepolizumab 750 mg	5	78

1 to 10 of 159Source ClinicalTrials.gov

See all 159 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mepolizumab 750 mg
Total, other adverse events	Mepolizumab 750 mg	72	78
Total, serious adverse events	Mepolizumab 750 mg	40	78

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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