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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early and Late Prognosis in Patients With Guillain-Barre Syndrome

NCT06041451

Guillain-Barre Syndrome

UNKNOWN PHASE4

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

NCT02221271

Guillain-Barré Syndrome

COMPLETED PHASE3

Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

NCT00004833

Guillain-Barre Syndrome

TERMINATED NA

A Study of Imlifidase in Patients With Guillain-Barré Syndrome

NCT03943589

Guillain-Barré Syndrome (GBS)

COMPLETED PHASE2

Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

NCT00515450

Generalized Myasthenia Gravis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Guillain-Barré Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GB-0998

Group Type EXPERIMENTAL

GB-0998

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GB-0998

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Venoglobulin-IH

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No