Generalized Myasthenia GravisPhase 3NCT00515450
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
A Phase 3 study testing GB-0998 (Intravenous immunoglobulin) and Plasmapheresis in people with Generalized Myasthenia Gravis, run by Benesis Corporation at 1 site in Japan.
Trial summary
This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) 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
- Generalized Myasthenia Gravis
- What is being tested?
- GB-0998 (Intravenous immunoglobulin) and Plasmapheresis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2007to Jun 2010
- 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
- Patients diagnosed as generalized myasthenia gravis
- Patients who are not controlled by current therapy and need plasmapheresis therapy
- Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent
- Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment
Who cannot join
- Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment
- Patients who had undergone thymectomy within 24 weeks prior to enrollment
- Patients with 3 points item in bulbar symptom of MG-ADL scale
- Patients with severe hepatic disorder, severe renal disorder or severe heat disorder
- Patients who have received treatment of malignant tumors
- Patients who have the anamnesis of shock or hypersensitivity to this drug
Show all 11Show fewer
- Patients who have been diagnosed as hereditary fructose intolerance
- Patients who have the anamnesis of cerebral infarction or symptom of these diseases
- Patients who have been diagnosed as IgA deficiency in their past history
- Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant
- Patients who were administered other investigational drug within 12 weeks before consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- GB-0998 (Intravenous immunoglobulin), Plasmapheresis
- Keywords
- Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0998 (Intravenous immunoglobulin)Biological
Also called Venoglobulin-IH
PlasmapheresisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: GB-0998 (Intravenous immunoglobulin) |
| 2 | Active comparator | Not described Receives: Procedure: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in QMG score
Measured: at 4 weeks
Secondary outcomes (1)
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
Measured: from beginning of the treatment through 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benesis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Masaharu Takamori, Director, Study chair, Neurological Center Kanazawa-Nishi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515450
- Sponsor's protocol ID
- 0998-B1
- Status last verified
- Jul 2010
- First submitted
- 10 Aug 2007
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT00515450
- Acronym / sponsor ID
- 0998-B1
- Conditions
- Generalized Myasthenia Gravis
- Keywords
- Myasthenia Gravis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Benesis CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Aug 2007 (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 randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: GB-0998 (Intravenous immunoglobulin) |
| 2 | Active comparator | Procedure: Plasmapheresis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed as generalized myasthenia gravis
- Patients who are not controlled by current therapy and need plasmapheresis therapy
- Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent
- Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment
Key exclusion criteria (11 listed)
- Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment
- Patients who had undergone thymectomy within 24 weeks prior to enrollment
- Patients with 3 points item in bulbar symptom of MG-ADL scale
- Patients with severe hepatic disorder, severe renal disorder or severe heat disorder
- 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-0998 (Intravenous immunoglobulin)Also: Venoglobulin-IH | Biological | 1 |
| Plasmapheresis | Procedure or surgery | 2 |
Primary outcome
Changes in QMG score
Time frame: at 4 weeks
1 secondary outcome
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
Time frame: from beginning of the treatment through 4th week
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 30 Jul 2010.
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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.
Masaharu Takamori, Director study chair
Neurological Center Kanazawa-Nishi Hospital
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 (Intravenous immunoglobulin) and Plasmapheresis in people with Generalized Myasthenia Gravis, run by Benesis Corporation 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 4 inclusion and 11 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 30 Jul 2010. 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?
Changes in QMG score (time frame: at 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 30 Jul 2010.