An open-label extension study to Study 100185 to evaluate long-term saftey, efficacy and optimal dosing frequency of 750mg intravenous mepolizumab in subjects with hypereosinophilic syndrome.
- Conditions
- Hypereosinophilic syndrome (HES)MedDRA version: 7.0Level: LLTClassification code 10048643
- Registration Number
- EUCTR2004-000930-35-BE
- Lead Sponsor
- SmithKline Beecham plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 84
• Subjects who have participated in Study MHE100185
• A female subject is eligible to enter the study if she is:
• 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 tubal 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:
- 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;
- 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Patients who have developed life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in the study per the principal investigator
• Has any of the following abnormal laboratory values at the Week 36/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 per µL.
• Has developed abnormal cardiac functions, as the following, within the 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 product as concurrent medication.
• Does not complete Week36/EW Visit assessments requitred 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To describe long-term safety of 750mg mepolizumab administered via iv infusion in subjects with HES at maximum dosing frequency of once every month.;Secondary Objective: • To describe durable effect of 750mg iv mepolizumab in maintaining the prednisone dose level of those subjects who completed 9 months of dosing of MHE100185 and achieved a prednisone dose <10mg<br>• To describe drable effect of 750mg iv mepolizumab in reducing blood eosinophil count<br>• To gain further information on a possible optimal dosing frequency of 750mg iv mepolizumab in HES subjects using blood eosinophil count as a dosing marker<br>• To describe clinical efficacy of 750mg iv mepolizumab greater than 9 months duration in subjects with various HES clinical manisfestations<br>• To gain further information on quality of life measurements in HES subjects treated with 750mg mepolizmab<br>;Primary end point(s): • Frequency of all adverse events.
- Secondary Outcome Measures
Name Time Method