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

NCT02342184 | Completed Phase 3

• 1 other identifier: B211-13
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain-Barré Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)

  4 weeks

Secondary Outcomes (12)

• days required for 1 grade improvement of FG

  1,2,3,4,6,8,12 weeks

• days required for 2 grade improvement of FG

  1,2,3,4,6,8,12 weeks

• changes in FG

  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

  4weeks

• days required for 1 grade improvement of the AG

  1,2,3,4,6,8,12 weeks

Study Arms (1)

GB-0998

EXPERIMENTAL

Drug: GB-0998

Interventions

GB-0998 DRUG

Also known as: Venoglobulin-IH

GB-0998

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In principle, patients are able to receive the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms.
• 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).
• Patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset.

You may not qualify if:

• Patients who have the anamnesis of shock or hypersensitivity to GB-0998.
• Patients who have been diagnosed as hereditary fructose intolerance.
• Patients who have impaired peripheral neuropathy except Guillain-Barré syndrome.
• Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy.
• Patients who have received treatment of malignant tumors.
• Patients who were administered immunoglobulin within 8 weeks before informed consent.
• Patients who have been diagnosed IgA deficiency in their past history.
• Patients with severe renal disorder or decreased cardiac function.
• Patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases.
• Patients with high risk of thromboembolism.
• Pregnant, lactating, and probably pregnant patients.
• Patients who were administered other investigational drug within 12 weeks before consent.

Sponsors & Collaborators

• Japan Blood Products Organization: lead

Study Sites (1)

Department of Neurology, Saitama Medical Center, Saitama Medical University

Kawagoe, Saitama, Japan

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyoichi Nomura

  Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2014
• First Posted: January 19, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2015-12

Locations

JP (1)