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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00097370




Registration number
NCT00097370
Ethics application status
Date submitted
22/11/2004
Date registered
23/11/2004

Titles & IDs
Public title
Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome
Scientific title
An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes
Secondary ID [1] 0 0
100901
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypereosinophilic Syndrome 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - mepolizumab

Experimental: mepolizumab - 750mg Intravenous, monthly and individual dosing schedule


Treatment: Drugs: mepolizumab
Study Drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Event (AE) During the Treatment Phase
Timepoint [1] 0 0
From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)
Primary outcome [2] 0 0
Number of Participants With Any Adverse Event (AE) During the Follow-up Phase
Timepoint [2] 0 0
From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)
Secondary outcome [1] 0 0
Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study
Timepoint [1] 0 0
up to approximately 6 years
Secondary outcome [2] 0 0
Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study
Timepoint [2] 0 0
up to approximately 6 years
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
up to approximately 6 years
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
up to approximately 6 years
Secondary outcome [5] 0 0
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;
Timepoint [5] 0 0
up to approximately 6 years
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
up to approximately 6 years
Secondary outcome [7] 0 0
Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3
Timepoint [7] 0 0
up to approximately 6 years
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
up to approximately 6 years
Secondary outcome [9] 0 0
Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
Timepoint [9] 0 0
Baseline and up to approximately 6 years
Secondary outcome [10] 0 0
Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
Timepoint [10] 0 0
Baseline and up to approximately 6 years
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Baseline and up to approximately 6 years
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline and up to approximately 6 years

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/09/2010
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [2] 0 0
GSK Investigational Site - West Perth
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Canada
State/province [13] 0 0
Manitoba
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
France
State/province [16] 0 0
Lille
Country [17] 0 0
France
State/province [17] 0 0
Suresnes
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Niedersachsen
Country [20] 0 0
Germany
State/province [20] 0 0
Schleswig-Holstein
Country [21] 0 0
Italy
State/province [21] 0 0
Emilia-Romagna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00097370