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

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Brief Title

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants With Any Adverse Event (AE) During the Treatment Phase

Secondary Outcome

 Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study

Condition

Hypereosinophilic Syndrome

Intervention

mepolizumab

Study Arms / Comparison Groups

 mepolizumab
Description:  750mg Intravenous, monthly and individual dosing schedule

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

78

Start Date

September 30, 2004

Completion Date

September 29, 2010

Primary Completion Date

September 29, 2010

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

GSK Clinical Trials, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00097370

Organization ID

100901


Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline


Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline


Verification Date

June 2017