Scleroderma, SystemicPhase 3NCT00348296
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
A Phase 3 study testing High-dose intravenous immunoglobulin (Venoglobulin-IH) in people with Scleroderma, Systemic, run by Benesis Corporation at 1 site in Japan.
Trial summary
This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, 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
- Scleroderma, Systemic
- What is being tested?
- High-dose intravenous immunoglobulin (Venoglobulin-IH)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2006to Jul 2009
- 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 who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma.
- Patients who have not less than 20 points of TSS.
- Patients with no appropriate therapeutic treatment.
Who cannot join
- Patients with severe hepatic disorder, severe renal disorder or severe heart disorder.
- Patients with malignant tumors.
- Patients who have the anamnesis of shock or hypersensitivity to this drug.
- 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 had any dose increase or new dosing of steroid within 12 weeks before consent.
- 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, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.
- Conditions
- Scleroderma, Systemic
- Being tested
- High-dose intravenous immunoglobulin (Venoglobulin-IH)
- Keywords
- Scleroderma, Systemic
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose intravenous immunoglobulin (Venoglobulin-IH)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in TSS at 12 weeks
Secondary outcomes (1)
Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies 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
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benesis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kazuhiko Takehara, Professor, Study chair, Kanazawa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348296
- Sponsor's protocol ID
- 0998-A1
- Status last verified
- Jul 2010
- First submitted
- 3 Jul 2006
- Last updated
- 30 Jul 2010
- Results posted
- No
Publications
Takehara K, Ihn H, Sato S. A randomized, double-blind, placebo-controlled trial: intravenous immunoglobulin treatment in patients with diffuse cutaneous systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):151-6. Epub 2013 Jul 23.
PubMed 23910617
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, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00348296
- Acronym / sponsor ID
- 0998-A1
- Conditions
- Scleroderma, Systemic
- Keywords
- Scleroderma, Systemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benesis CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Jul 2006 (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, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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)
- Patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma.
- Patients who have not less than 20 points of TSS.
- Patients with no appropriate therapeutic treatment.
Key exclusion criteria (8 listed)
- Patients with severe hepatic disorder, severe renal disorder or severe heart disorder.
- Patients with malignant tumors.
- Patients who have the anamnesis of shock or hypersensitivity to this drug.
- 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.
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 |
|---|---|---|
| High-dose intravenous immunoglobulin (Venoglobulin-IH) | Drug | – |
Primary outcome
Changes in TSS at 12 weeks
1 secondary outcome
Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.
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.
- Derived from this study: PubMed 23910617Takehara K, Ihn H, Sato S. A randomized, double-blind, placebo-controlled trial: intravenous immunoglobulin treatment in patients with diffuse cutaneous systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):151-6. Epub 2013 Jul 23.
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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.
Kazuhiko Takehara, Professor study chair
Kanazawa University
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 High-dose intravenous immunoglobulin (Venoglobulin-IH) in people with Scleroderma, Systemic, 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 3 inclusion and 8 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 TSS at 12 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348296, which also lists 1 linked publication.
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.