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

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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

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.

Condition or disease Intervention/treatment Phase
Guillain-Barré Syndrome Drug: GB-0998 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: GB-0998 Drug: GB-0998
Other Name: Venoglobulin-IH




Primary Outcome Measures :
  1. Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. days required for 1 grade improvement of FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  2. days required for 2 grade improvement of FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  3. changes in FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  4. proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline [ Time Frame: 4weeks ]
  5. days required for 1 grade improvement of the AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  6. days required for 2 grade improvement of the AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  7. changes in AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  8. changes in grip strength [ Time Frame: 1,2,4,8,12 weeks ]
  9. changes in manual muscle testing (MMT) [ Time Frame: 1,2,4,8,12 weeks ]
  10. changes in activity of daily living (ADL) [ Time Frame: 1,2,4,8,12 weeks ]
  11. changes in motor nerve conduction velocity [ Time Frame: 4,12 weeks ]
  12. changes in FG on rescue treatment [ Time Frame: 1,2,3,4,6,8,12 weeks ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342184


Locations
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Japan
Department of Neurology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama, Japan
Sponsors and Collaborators
Japan Blood Products Organization
Investigators
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Study Chair: Kyoichi Nomura Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan

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Responsible Party: Japan Blood Products Organization
ClinicalTrials.gov Identifier: NCT02342184     History of Changes
Other Study ID Numbers: B211-13
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs