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

NCT ID: NCT00097370

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-09-29

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.

Conditions

Hypereosinophilic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mepolizumab

750mg Intravenous, monthly and individual dosing schedule

Group Type: EXPERIMENTAL

mepolizumab

Intervention Type: DRUG

Study Drug

Interventions

mepolizumab

Study Drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Rochester, Minnesota, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

St Leonards, New South Wales, Australia

GSK Investigational Site

West Perth, Western Australia, Australia

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Lille, , France

GSK Investigational Site

Suresnes, , France

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, Germany

GSK Investigational Site

Bologna, Emilia-Romagna, Italy

Countries

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

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

100901

Identifier Type: -

Identifier Source: org_study_id