Clinical trial NCT00097370: Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome
Official title: An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypereosinophilic Syndrome
Keywords: Mepolizumab
Open-label
Anti-IL-5
Hypereosinophilic Syndrome
Hypereosinophilia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-11-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

* Signed informed consent.
* Subjects who have participated in Study MHE100185 and have been administered at least 2 doses of study medication.
* Not pregnant or nursing
* Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or
* Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea \[even severe\], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following:1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; Or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose:Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; Implants of levonorgestrel;Injectable progestogen;Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; Oral contraceptives (either combined or progestogen only)

Exclusion criteria:

* Has developed life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator
* Has any of the following abnormal laboratory values at the Week36/EW Visit of Study MHE100185: • Serum creatinine ≥3 times institutional upper limit normal (ULN); • AST or/ALT ≥5 times institutional ULN; • Platelet count \< 50,000/uL
* Has developed abnormal cardiac functions, as the following, within past 3 months:• Left ventricular ejection fraction (LVEF) \< 20%; • NYHA class IIIb or IV; • Angina or acute myocardial infarction
* Has developed allergic reaction to Study MHE100185 investigational product Use of an investigational drug as concurrent medication
* Does not complete Week36/EW Visit assessments required in Study MHE100185
* Has completed or been terminated from Study MHE100185 for more than 1 month
* Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months
* Positive pregnancy test at the Week36/EW Visit of Study MHE100185

Primary outcomes:
measure: Number of Participants With Any Adverse Event (AE) During the Treatment Phase
timeFrame: From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)
measure: Number of Participants With Any Adverse Event (AE) During the Follow-up Phase
timeFrame: From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)
Secondary outcomes:
measure: Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study
timeFrame: up to approximately 6 years
measure: Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study
timeFrame: up to approximately 6 years
measure: 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
timeFrame: up to approximately 6 years
measure: 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
timeFrame: up to approximately 6 years
measure: 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;
timeFrame: up to approximately 6 years
measure: 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
timeFrame: up to approximately 6 years
measure: Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3
timeFrame: up to approximately 6 years
measure: 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
timeFrame: up to approximately 6 years
measure: Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
timeFrame: Baseline and up to approximately 6 years
measure: Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
timeFrame: Baseline and up to approximately 6 years
measure: 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
timeFrame: Baseline and up to approximately 6 years
measure: 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
timeFrame: Baseline and up to approximately 6 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: West Perth
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Lille
country: France
facility: GSK Investigational Site
city: Suresnes
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Bramstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: