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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00097370
• Date of registration: 22/11/2004
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• 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
• Date of first enrolment: September 30, 2004
• Target sample size: 78
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00097370
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypereosinophilic Syndrome

Intervention(s)

Drug: mepolizumab

Primary Outcome(s)

Number of Participants With Any Adverse Event (AE) During the Follow-up Phase [Time Frame: From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)]

Number of Participants With Any Adverse Event (AE) During the Treatment Phase [Time Frame: From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)]

Secondary Outcome(s)

Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter [Time Frame: Baseline and up to approximately 6 years]

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 [Time Frame: up to approximately 6 years]

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; [Time Frame: up to approximately 6 years]

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 [Time Frame: Baseline and up to approximately 6 years]

Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter [Time Frame: Baseline and up to approximately 6 years]

Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study [Time Frame: up to approximately 6 years]

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 [Time Frame: up to approximately 6 years]

Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3 [Time Frame: up to approximately 6 years]

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 [Time Frame: up to approximately 6 years]

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 [Time Frame: up to approximately 6 years]

Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study [Time Frame: up to approximately 6 years]

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 [Time Frame: Baseline and up to approximately 6 years]

Secondary ID(s)

100901

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00097370