Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

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Brief Title

Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Official Title

A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES

Brief Summary

      Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms
      which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells,
      various end-organ damages (including skin, heart, lung, nervous system and digestive system
      etc.), and with exclusion of known secondary causes of hypereosinophilia.

      HES has a high morbidity/mortality rate. The major treatment of HES has been systemic
      corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon)
      with the intention to lower eosinophil counts and therefore to slow down the progression of
      disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia
      in some patients, some may eventually become nonresponsive and intolerable to the amount of
      side effects of the long-term therapy with these medications.

      Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5
      (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective
      in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES
      clinical signs and symptoms. This study intends to further evaluate the
      corticosteroid-sparing and clinical benefit of mepolizumab in HES.
    

Detailed Description

      A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study
      to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously
      in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of
      Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of subjects who achieve a total daily prednisone dose of 					

Secondary Outcome

 Assess the effect of mepo in lowering prednisone dose and blood eosinophil count, improving HES-associated skin manifestations, improving quality of life (QoL), safety and tolerability.

Condition

Hypereosinophilia

Intervention

mepolizumab


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

86

Start Date

March 23, 2004

Completion Date

May 1, 2006

Primary Completion Date

May 1, 2006

Eligibility Criteria

        Inclusion criteria:

          -  Documented history of Hypereosinophilic Syndrome (HES)

          -  Eosinophil count greater than 1500 cells for 6 months

          -  Signs and symptoms of organ system involvement

          -  No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive
             evaluation.

          -  Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study
             medication.

          -  Not pregnant or nursing.

        Exclusion criteria:

          -  Churg-Strauss Syndrome

          -  Wegener's Granulomatosis

          -  Lymphoma, hematological malignancy, advanced and metastatic solid tumors

          -  Chemotherapy, radiotherapy or interleukin 2 treatment.
      

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

NCT00086658

Organization ID

100185


Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline


Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline


Verification Date

May 2020