Stevens-Johnson SyndromePhase 3NCT01696500
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
A Phase 3 study testing Intravenous immunoglobulin in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
Trial summary
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
- What is being tested?
- Intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Jun 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who the disease evaluation score is more than 14 at study medication received.
- Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received and continued this treatment more than 2 days.
- Patients with treatment effect is insufficiency before study medication received and need additional treatment.
- Patients aged more than twenty years old at informed consent.
Who cannot join
- Patients who the SCORTEN score is more than 4 at study medication received.
- Patients with multiple organ failure at study medication received.
- Patients with severe respiratory disorder at study medication received.
- Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
- Patients with malignancy during treatment at informed consent.
- Patients treated with corticosteroids dosage is change at 2 days before study medication received.
Show all 18Show fewer
- Patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at 2 days before study medication received.
- Patients treated with plasmapheresis at 2 days before study medication received.
- Patients treated with high-dose intravenous immunoglobulin at 28 days before informed consent.
- Patients with history of shock or hypersensitivity for NPB-01.
- Patients with IgA deficiency.
- Patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis et al.
- Patients with more than 2mg/dL serum creatinine.
- Patients with severe cerebro- or cardiovascular disorders.
- Patients with high risk of thromboembolism.
- Patients with hemolytic/hemorrhagic anemia.
- Patients with severe decreased cardiac function.
- Patients with decreased platelet less than 75,000/μL..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be evaluated the disease evaluation score et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 20 days after the start of the study treatment.
- Being tested
- Intravenous immunoglobulin
- Keywords
- IVIG in Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Patients with Stevens-Johnson syndrome, Toxic Epidermal Necrolysis unresponsive to corticosteroids
- Medical subject headings
- Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous immunoglobulinDrug
| Study group | Role | What they receive |
|---|---|---|
| NPB-01 | Experimental | Not described Receives: Drug: Intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease evaluation score
Measured: 7 days
Secondary outcomes (3)
disease evaluation score
Measured: 4 ,10 ,20 days
avulsed skin area
Measured: 20 days
erythematous area
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens-Johnson 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696500
- Sponsor's protocol ID
- NPB-01-07/C-01
- Status last verified
- Oct 2013
- First submitted
- 20 Sep 2012
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
- ClinicalTrials.gov ID
- NCT01696500
- Acronym / sponsor ID
- NPB-01-07/C-01
- Keywords
- IVIG in Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Patients with Stevens-Johnson syndrome, Toxic Epidermal Necrolysis unresponsive to corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Oct 2012 (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.
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be evaluated the disease evaluation score et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 20 days after the start of the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPB-01 | Experimental | Drug: Intravenous immunoglobulin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who the disease evaluation score is more than 14 at study medication received.
- Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received and continued this treatment more than 2 days.
- Patients with treatment effect is insufficiency before study medication received and need additional treatment.
- Patients aged more than twenty years old at informed consent.
Key exclusion criteria (18 listed)
- Patients who the SCORTEN score is more than 4 at study medication received.
- Patients with multiple organ failure at study medication received.
- Patients with severe respiratory disorder at study medication received.
- Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
- Patients with malignancy during treatment at informed consent.
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 |
|---|---|---|
| Intravenous immunoglobulin | Drug | NPB-01 |
Primary outcome
disease evaluation score
Time frame: 7 days
3 secondary outcomes
disease evaluation score
Time frame: 4 ,10 ,20 days
avulsed skin area
Time frame: 20 days
erythematous area
Time frame: 20 days
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 2 Jul 2014.
Related trials for Stevens-Johnson Syndrome
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
Not yet recruitingPhase 4
HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness
Gout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis
Not yet recruitingPhase 1/2
New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.
Toxic Epidermal Necrolysis, Immunotherapy
RecruitingPhase 1/2
LYell SYndrome MEsenchymal Stromal Cells Treatment
Epidermal Necrolysis, Lyell Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravenous immunoglobulin in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Nihon Pharmaceutical Co., Ltd 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 18 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 2 Jul 2014. 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?
disease evaluation score (time frame: 7 days). 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 2 Jul 2014.