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Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342184
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Japan Blood Products Organization

Tracking Information
First Submitted Date  ICMJE December 25, 2014
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date February 4, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG) [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02342184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
  • days required for 1 grade improvement of FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • days required for 2 grade improvement of FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • changes in FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline [ Time Frame: 4weeks ]
  • days required for 1 grade improvement of the AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • days required for 2 grade improvement of the AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • changes in AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • changes in grip strength [ Time Frame: 1,2,4,8,12 weeks ]
  • changes in manual muscle testing (MMT) [ Time Frame: 1,2,4,8,12 weeks ]
  • changes in activity of daily living (ADL) [ Time Frame: 1,2,4,8,12 weeks ]
  • changes in motor nerve conduction velocity [ Time Frame: 4,12 weeks ]
  • changes in FG on rescue treatment [ Time Frame: 1,2,3,4,6,8,12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
Official Title  ICMJE Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
Brief Summary This study will carry out to assess the efficacy of GB-0998 (intravenous immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to assess the safety of GB-0998.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Guillain-Barré Syndrome
Intervention  ICMJE Drug: GB-0998
Other Name: Venoglobulin-IH
Study Arms  ICMJE Experimental: GB-0998
Intervention: Drug: GB-0998
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
21
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2015)
25
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. In principle, patients are able to receive the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms.
  2. Patients with predominant motor neuropathy and FG is grade 4 or grade 5 (if symptoms is progressive, patients with FG is grade 3 involve in this study).
  3. Patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset.

Exclusion Criteria:

  1. Patients who have the anamnesis of shock or hypersensitivity to GB-0998.
  2. Patients who have been diagnosed as hereditary fructose intolerance.
  3. Patients who have impaired peripheral neuropathy except Guillain-Barré syndrome.
  4. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy.
  5. Patients who have received treatment of malignant tumors.
  6. Patients who were administered immunoglobulin within 8 weeks before informed consent.
  7. Patients who have been diagnosed IgA deficiency in their past history.
  8. Patients with severe renal disorder or decreased cardiac function.
  9. Patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases.
  10. Patients with high risk of thromboembolism.
  11. Pregnant, lactating, and probably pregnant patients.
  12. Patients who were administered other investigational drug within 12 weeks before consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342184
Other Study ID Numbers  ICMJE B211-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Japan Blood Products Organization
Study Sponsor  ICMJE Japan Blood Products Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kyoichi Nomura Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
PRS Account Japan Blood Products Organization
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP