Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS

Study Identifier:
C08-002A
ClinicalTrials.gov Identifier:
NCT00844545
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Atypical Hemolytic Uremic Syndrome
Study Drug
  • Drug: Eculizumab
Date
May 2009 - Sep 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Exclusion Criteria
  • TTP, (defined as ADAMTS-13 activity \<5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory
  • Malignancy within 5 years of screening
  • Typical HUS (Shiga toxin +)
  • Known HIV infection
  • Identified drug exposure-related HUS.
  • Infection-related HUS
  • HUS related to bone marrow transplant
  • HUS related to vitamin B12 deficiency
  • Renal function status requiring chronic dialysis
  • Patients with a confirmed diagnosis of sepsis
  • Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease
  • Pregnancy or lactation
  • Unresolved meningococcal disease
  • Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome
  • Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
  • Patients who have received previous treatment with eculizumab
  • Patients receiving IVIG within 8 weeks or Rituximab therapy within 12 weeks of screening.
  • Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: \[1\] part of an established post-transplant anti-rejection regime, \[2\] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and \[3\] dose of such medications have been unchanged for at least 4 weeks prior to the screening period or \[4\] patient is experiencing an acute aHUS relapse immediately after transplant
  • Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period, or a washout period of at least 2 weeks from the last dose of ESA therapy.
  • Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial.
  • Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Atypical Hemolytic Uremic Syndrome
Study Drug
  • Drug: Eculizumab
Date
May 2009 - Sep 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Exclusion Criteria
  • TTP, (defined as ADAMTS-13 activity \<5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory
  • Malignancy within 5 years of screening
  • Typical HUS (Shiga toxin +)
  • Known HIV infection
  • Identified drug exposure-related HUS.
  • Infection-related HUS
  • HUS related to bone marrow transplant
  • HUS related to vitamin B12 deficiency
  • Renal function status requiring chronic dialysis
  • Patients with a confirmed diagnosis of sepsis
  • Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease
  • Pregnancy or lactation
  • Unresolved meningococcal disease
  • Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome
  • Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
  • Patients who have received previous treatment with eculizumab
  • Patients receiving IVIG within 8 weeks or Rituximab therapy within 12 weeks of screening.
  • Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: \[1\] part of an established post-transplant anti-rejection regime, \[2\] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and \[3\] dose of such medications have been unchanged for at least 4 weeks prior to the screening period or \[4\] patient is experiencing an acute aHUS relapse immediately after transplant
  • Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period, or a washout period of at least 2 weeks from the last dose of ESA therapy.
  • Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial.
  • Hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Protocol Summary

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

Trial Locations

Location
Status
Location
Atlanta, Georgia, United States, 30322
Status
N/A
Location
Fort Wayne, Indiana, United States, 46804
Status
N/A
Location
New York, New York, United States, 10032
Status
N/A
Location
New York, New York, United States, 10065
Status
N/A
Location
Grapevine, Texas, United States, 76051
Status
N/A
Location
Houston, Texas, United States, 77030
Status
N/A
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