Guillain-Barré SyndromePhase 3NCT02342184
Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
A Phase 3 study testing GB-0998 in people with Guillain-Barré Syndrome, run by Japan Blood Products Organization at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Guillain-Barré Syndrome
- What is being tested?
- GB-0998
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2014to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Neurology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama
About this study
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
- Being tested
- GB-0998
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0998Drug
Also called Venoglobulin-IH
| Study group | Role | What they receive |
|---|---|---|
| GB-0998 | Experimental | Not described Receives: Drug: GB-0998 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
Measured: 4 weeks
Secondary outcomes (12)
days required for 1 grade improvement of FG
Measured: 1,2,3,4,6,8,12 weeks
days required for 2 grade improvement of FG
Measured: 1,2,3,4,6,8,12 weeks
changes in FG
Measured: 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
Measured: 4weeks
days required for 1 grade improvement of the AG
Measured: 1,2,3,4,6,8,12 weeks
days required for 2 grade improvement of the AG
Measured: 1,2,3,4,6,8,12 weeks
changes in AG
Measured: 1,2,3,4,6,8,12 weeks
changes in grip strength
Measured: 1,2,4,8,12 weeks
changes in manual muscle testing (MMT)
Measured: 1,2,4,8,12 weeks
changes in activity of daily living (ADL)
Measured: 1,2,4,8,12 weeks
changes in motor nerve conduction velocity
Measured: 4,12 weeks
changes in FG on rescue treatment
Measured: 1,2,3,4,6,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barré SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Blood Products Organization
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoichi Nomura, Study chair, Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342184
- Sponsor's protocol ID
- B211-13
- Status last verified
- Dec 2015
- First submitted
- 25 Dec 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT02342184
- Acronym / sponsor ID
- B211-13
- Conditions
- Guillain-Barré Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Japan Blood Products OrganizationIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB-0998 | Experimental | Drug: GB-0998 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-0998Also: Venoglobulin-IH | Drug | GB-0998 |
Primary outcome
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
Time frame: 4 weeks
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoichi Nomura study chair
Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GB-0998 in people with Guillain-Barré Syndrome, run by Japan Blood Products Organization at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.