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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01755429
Other study ID # C11-004J
Secondary ID
Status Completed
Phase N/A
First received December 4, 2012
Last updated December 21, 2012
Start date May 2012
Est. completion date July 2012

Study information

Verified date February 2012
Source Alexion Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date July 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Patient and/or legal guardian must be willing and able to give written informed consent and id the patient is not an adult and able to read and write, the patient is willing to give written informed assent

2. Eculizumab treatment initiated as personal importation for aHUS in 201

Exclusion Criteria:

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Shinshu University School of Medicine Matsumoto
Japan Tokyo Medical and Dental University Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in platelet count from baseline 26 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT01757431 - The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS) Phase 2
Not yet recruiting NCT06312644 - Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Completed NCT02949128 - Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Phase 3
Completed NCT03131219 - Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS) Phase 3
Completed NCT01770951 - A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)