Severe SepsisPhase 3NCT01315496
GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
A Phase 3 study testing Immunoglobulin G in people with Severe Sepsis and Septic Shock, run by Green Cross Corporation at 17 sites in South Korea.
Trial summary
This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- Immunoglobulin G
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 17 sitesSouth Korea
- Study dates
- Oct 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe sepsis or septic shock, if all of the following criteria is satisfied.
- Age ≥ 18 years
- Proved or suspected infection in at least one site
- pneumonia
- urinary tract infection
- intra-abdominal infection
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- primary bloodstream infection
- skin and soft tissue infection 3. Three or more of the following
- a core temperature ≥ 38° C or ≤ 36° C
- a heart rate ≥ 90 beats/min
- a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process
- a white blood cell count ≥ 12000/mm3 or ≤ 4000/ mm3 or immature neutrophils > 10% 4. Acute organ failure in one or more of the following
- kidney
- respiratory system
- blood system
- metabolic system
- circulatory system 5. APACHE score ≥ 20 and ≤ 29 6. Patient can treatment with GCIV in ICU within at least 48 hours 7. Informed consent
Who cannot join
- Pregnant or breast-feeding women
- a weight > 100kg
- discharged from the hospital at least 14 days prior to new admission
- Transferred from another hospital staying more than 48 hours
- allergy or shock of IVIG
- Treated with IVIG within the 12 weeks immediately preceding enrolment in this study
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- IgA deficiency
- Hypernatremia or hyperhydration
- Proved or suspected HIV or AIDS patients(CD4+ <200mL)
- Current participation in any study within the last 4 weeks
- Do not resuscitate (DNR) status
- Patient's death is considered imminent due to coexisting disease
- physicians decision to exclude patients from this protocol
- Immunocompromised patients
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Korea University Ansan Hospital
Ansan
Hallym University Sacred Heart Hospital
Anyang
Chungbuk National University Hospital
Cheongju-si
Gachon University Gil Hospital
Incheon
Gyrongsang National University Hospital
Jinju-si, Gyeongsangnam-do,
Asan Medical Center
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Kangdong Sacred Heart Hospital
Seoul
Kangnam Sacred Heart Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Medical Center
Seoul
Severance Hospital
Seoul
The Catholic of Korea Yeouido ST. Mary's Hospital
Seoul
Ajuo University Hospital
Suwon
Wonju Christian Hospital
Wŏnju
About this study
Official title: A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S Inj.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock
This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.
Read the detailed description
A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S inj.(Human Immunoglobulin G)' as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or Septic Shock.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- Immunoglobulin G
- Keywords
- Human Immunoglobulin G, Sepsis, Septic shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin GDrug
Also called GCIV
Immunoglobulin 1.5-2g/Kg/3days
| Study group | Role | What they receive |
|---|---|---|
| Imunoglobulin G | Experimental | The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days. Receives: Drug: Immunoglobulin G |
| Placebo control | Placebo comparator | The enrolled patients will be randomized to receive supplementation of placebo (0.9% NaCl) in ICU within 48 hours after hospital arrival admission for 3 consecutive days. Receives: Drug: Immunoglobulin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 28th day
Secondary outcomes (4)
All cause mortality
Measured: 7th day
Course of SOFA subscores
Measured: 5 Times: D-1, D1, D3, D5, D7
Laboratory Test
sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
Measured: 7th Day
Duration of ICU and general ward admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Responsible party
- Sponsor
- Investigators
- Min Ja Kim, Professor, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315496
- Sponsor's protocol ID
- GCIV_P3
- Status last verified
- Apr 2013
- First submitted
- 14 Mar 2011
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S Inj.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT01315496
- Acronym / sponsor ID
- GCIV_P3
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Human Immunoglobulin G, Sepsis, Septic shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Study start
- Oct 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Mar 2011 (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 is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.
Detailed description
A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S inj.(Human Immunoglobulin G)' as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or Septic Shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imunoglobulin G | Experimental | Drug: Immunoglobulin GThe enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days. |
| Placebo control | Placebo comparator | Drug: Immunoglobulin GThe enrolled patients will be randomized to receive supplementation of placebo (0.9% NaCl) in ICU within 48 hours after hospital arrival admission for 3 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with severe sepsis or septic shock, if all of the following criteria is satisfied.
- pneumonia
- urinary tract infection
- intra-abdominal infection
- primary bloodstream infection
Key exclusion criteria (14 listed)
- Pregnant or breast-feeding women
- a weight > 100kg
- discharged from the hospital at least 14 days prior to new admission
- Transferred from another hospital staying more than 48 hours
- allergy or shock of IVIG
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 |
|---|---|---|
| Immunoglobulin GAlso: GCIVImmunoglobulin 1.5-2g/Kg/3days | Drug | Imunoglobulin G, Placebo control |
Primary outcome
All cause mortality
Time frame: 28th day
4 secondary outcomes
All cause mortality
Time frame: 7th day
Course of SOFA subscores
Time frame: 5 Times: D-1, D1, D3, D5, D7
Laboratory Test
Time frame: 7th Day
Duration of ICU and general ward admission
Time frame: 28 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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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.
Min Ja Kim, Professor principal investigator
Korea University Anam Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunoglobulin G in people with Severe Sepsis and Septic Shock, run by Green Cross Corporation at 17 sites in South Korea.
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 17 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
All cause mortality (time frame: 28th day). 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 Apr 2013.