GSK: Protocol Summary for 100901

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Protocol Summary for 100901

Protocol Summary
Protocol Id:	100901
Secondary Ids:
Title:	An Open-Label Extension Study to Study MHE100185, to Evaluate Long-term Safety, Efficacy and Optimal Dosing Frequency of 750 mg Intravenous Mepolizumab in Subjects with Hypereosinophilic Syndromes
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CBER
IND/IDE Number:	11,295
IND/IDE Serial Number:	0011
Has Expanded Access?:
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:
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.
Detailed Description:
Record Verification Date:	October 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	September 2004
Study Completion Date:	September 2010
Study Completion Date Type:	Actual
Primary Completion Date:	December 2009
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Non-randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Frequency of all Adverse Events yes 6 years
Secondary Outcomes:	Blood eosinophil count (with consideration of their HES background therapy) during Stages 1-3 6 years Proportion of subjects by dosing frequency groups (defined as two week dosing ranges greater than a 4 week interval) at the end of Stage 2 6 years QoL and current health status: physical summary score of the SF12TM 3 months after the start of study MHE100901 and every 6 months thereafter 6 years Pruritus visual analogue scale (pVAS) 3 months after the start of study MHE100901 and every 6 months thereafter 6 years Proportion of subjects achieving an eosinophil level of < 600cell/ul (in addition to the lowest background HES therapy) at the end of study MHE100901 6 years For those subjects who completed 9 months of dosing in study MHE100185 and achieved a prednisone level ≤10mg ; the proportion of subjects achieving ≤ 10mg prednisone (as sole background therapy) for ≥ 3months 6 years - Describe maintenance of durable effect on prednisone dose level. - Describe durable effect in reducing blood eosinophil count. - Optimal dosing frequency of mepolizumab. - Quality of life measures. 6 years Proportion of subjects achieving a prednisone level of ≤10mg (as sole background therapy) at the end of study MHE100901 6 years For those subjects who entered stage 1 from study MHE100185 with >10mg prednisone; the proportion of subjects achieving a prednisone dose ≤10mg (as sole background therapy) for≥3 months 6 years For those subjects who entered stage 2 from study MHE100185 with a prednisone level of ≤10mg prednisone; the proportion of subjects achieving a prednisone dose ≤10mg (as sole background therapy) for ≥3 months 6 years Erythema/edema score 3 months after the start of study MHE100901 and every 6 months thereafter 6 years For those subjects who completed 9 months of dosing in study MHE100185 and achieved a prednisone level > 10mg at the end of Study MHE100185; the proportion of subjects achieving ≤10mg prednisone (as sole background therapy) for ≥ 8 weeks 6 years QoL and current health status: mental summary score of the SF12TM 3 months after the start of study MHE100901 and every 6 months thereafter 6 years
Conditions:	Hypereosinophilic Syndrome
Keywords:	Hypereosinophilic Syndrome Anti-IL-5 Open-label Mepolizumab Hypereosinophilia
Eligibility Criteria:	Click to view inclusion/exclusion 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
Gender:	Both
Minimum Age:	18 Year
Maximum Age:	75 Year
Enrollment:	78
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Australia (click to view all sites in Australia) GSK Investigational Site St Leonards, New South Wales, 2065; Completed; GSK Investigational Site West Perth, Western Australia, 6005; Completed; Belgium (click to view all sites in Belgium) GSK Investigational Site Leuven, 3000; Completed; Canada (click to view all sites in Canada) GSK Investigational Site Winnipeg, Manitoba, R3C 0N2; Completed; GSK Investigational Site Halifax, Nova Scotia, B3H 1V7; Completed; GSK Investigational Site Toronto, Ontario, M5V 2T3; Completed; GSK Investigational Site Hamilton, Ontario, L8N 3Z5; Completed; France (click to view all sites in France) GSK Investigational Site Suresnes, 92150; Completed; GSK Investigational Site Lille, 59000; Completed; Germany (click to view all sites in Germany) GSK Investigational Site Muenchen, Bayern, 80802; Completed; GSK Investigational Site Hannover, Niedersachsen, 30625; Completed; GSK Investigational Site Bad Bramstedt, Schleswig-Holstein, 24576; Completed; Italy (click to view all sites in Italy) GSK Investigational Site Bologna, Emilia-Romagna, 40138; Completed; United States (click to view all sites in United States) California (click to view) GSK Investigational Site San Diego, California, 92103; Completed; Colorado (click to view) GSK Investigational Site Denver, Colorado, 80206; Completed; Maryland (click to view) GSK Investigational Site Bethesda, Maryland, 20892; Completed; Massachusetts (click to view) GSK Investigational Site Boston, Massachusetts, 02215; Completed; Minnesota (click to view) GSK Investigational Site Rochester, Minnesota, 55905; Completed; Ohio (click to view) GSK Investigational Site Cincinnati, Ohio, 45229; Completed; Tennessee (click to view) GSK Investigational Site Nashville, Tennessee, 37203-1424; Completed; Utah (click to view) GSK Investigational Site Salt Lake City, Utah, 84132; Completed; Virginia (click to view) GSK Investigational Site Richmond, Virginia, 23298; Completed; Wisconsin (click to view) GSK Investigational Site Madison, Wisconsin, 53705; Completed;

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Protocol Summary for 100901