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Trial record 6 of 40 for:    "paroxysmal nocturnal hemoglobinuria"

E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

This study has been completed.
Sponsor:
Collaborator:
CMIC Co, Ltd.
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01194804
First received: August 30, 2010
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be conducted.


Condition Intervention Phase
Paroxysmal Nocturnal Hemoglobinuria
Drug: Eculizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Efficacy of Eculizumab treatment [ Time Frame: Baseline through Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of LDH [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of total scores of FACIT-Fatigue scale [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of PNH RBC [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Number of units of Packed RBCs transfused [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Lactate dehydrogenase (LDH) area under the curve (AUC) [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of plasma free Hemoglobin [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of total EORTC QLQ-C30 score [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2008
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eculizumab
Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
Drug: Eculizumab
Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Other Name: Soliris

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have fully completed C07-001 study 12-week treatment period

Exclusion Criteria:

  • Patients who terminated early from the C07-001 study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01194804     History of Changes
Other Study ID Numbers: E07-001
Study First Received: August 30, 2010
Last Updated: December 5, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Alexion Pharmaceuticals:
Hemolytic Paroxysmal Nocturnal Hemoglobinuria
Eculizumab
PNH

Additional relevant MeSH terms:
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Anemia
Anemia, Hemolytic
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 25, 2014