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Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

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ClinicalTrials.gov Identifier: NCT02221271
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd

Brief Summary:

Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days.

Patients evaluate the Functional Grade(FG) and Arm Grade(AG) et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.


Condition or disease Intervention/treatment Phase
Guillain-Barré Syndrome Drug: NPB-01 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: NPB-01 Drug: NPB-01



Primary Outcome Measures :
  1. proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks. [ Time Frame: Baseline,4weeks ]

Secondary Outcome Measures :
  1. days required for 1 grade improvement of the Hughes functional grading scale(FG) [ Time Frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
  2. days required for 2 grade improvement of the Hughes functional grading scale(FG) [ Time Frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
  3. changes in Hughes functional grading scale(FG) [ Time Frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
  4. proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks. [ Time Frame: Baseline,4weeks ]
  5. days required for 1 grade improvement of the Arm Grade(AG) [ Time Frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
  6. days required for 2 grade improvement of the Arm Grade(AG) [ Time Frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
  7. changes in Arm Grade(AG) [ Time Frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
  8. changes in manual muscle testing(MMT) [ Time Frame: Baseline,1,2,3,4,8,12 weeks ]
  9. changes in grip strength [ Time Frame: Baseline,1,2,3,4,8,12 weeks ]
  10. changes in activity of daily living(ADL) [ Time Frame: Baseline,1,2,3,4,8,12 weeks ]
  11. changes in electrophysiological findings [ Time Frame: Baseline,4,12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
  2. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).
  3. Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
  4. Patients with greater than or equal to 18 years old at informed consent.

Exclusion Criteria:

  1. Patients with history of shock for NPB-01.
  2. Patients with history of hypersensitivity for NPB-01.
  3. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.
  4. Patients with malignancy at informed consent.
  5. Patients treated with immune globulin at 8 weeks before informed consent.
  6. Patients with IgA deficiency.
  7. Patients with impaired liver function.
  8. Patients with impaired renal function.
  9. Patients with cerebro- or cardiovascular disorders.
  10. Patients with high risk of thromboembolism.
  11. Patients with hemolytic/hemorrhagic anemia.
  12. Patients with decreased cardiac function.
  13. Patients with decreased platelet.

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): NCT02221271


Locations
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Japan
Nihon Pharmaceutical Co., Ltd
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd

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Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02221271     History of Changes
Other Study ID Numbers: NPB-01-13/C-01
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Syndrome
Guillain-Barre 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