Primary Immune DeficiencyNCT01166074
Retrospective Chart Review of Subcutaneous IgG Use in Infants
An observational study of Primary Immune Deficiency, run by CSL Behring at 5 sites in United States.
Trial summary
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- Subcutaneous IgG (SCIG)
- Type of treatment
- Injection or infusion
- How many people
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2010to Dec 2010
- Phase
- Observational
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 2 years of age
Who may be able to join
- Infants who received more than one dose of IgG by the subcutaneous route before the age of two years.
- Consent of parent/guardian if required by institution/IRB.
Who cannot join
- Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy.
- Concomitant treatment with plasma, other blood products or IGIV while on SCIG.
- Lack of consent by parent/guardian (if required by Institution/IRB).
- Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Children's Hospital of Los Angeles
Los Angeles, California, 90027
St. Judes Children's Research Hospital
Memphis, Tennessee, 38105
Midwest Immunology Clinic
Plymouth, Minnesota, 55446
University of South Florida
Tampa, Florida, 33612
About this study
Official title: Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
- Conditions
- Primary Immune Deficiency
- Being tested
- Subcutaneous IgG (SCIG)
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous IgG (SCIG)Biological
Also called Vivaglobin, SCIG
Administered according to normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| SCIG | Not described Receives: Biological: Subcutaneous IgG (SCIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCIG use
To describe the use of SCIG in infants below the age of two years in major academic medical centers and immunologists' practices in the US
Measured: 1 year
Secondary outcomes (1)
Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Melvin Berger, MD, PhD, Principal investigator, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166074
- Sponsor's protocol ID
- Ig_6001_R_D
- Status last verified
- Feb 2011
- First submitted
- 19 Jul 2010
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
- ClinicalTrials.gov ID
- NCT01166074
- Acronym / sponsor ID
- Ig_6001_R_D
- Conditions
- Primary Immune Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jul 2010 (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 a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCIG | – | Biological: Subcutaneous IgG (SCIG) |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 2 years of age
Key inclusion criteria (2 listed)
- Infants who received more than one dose of IgG by the subcutaneous route before the age of two years.
- Consent of parent/guardian if required by institution/IRB.
Key exclusion criteria (4 listed)
- Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy.
- Concomitant treatment with plasma, other blood products or IGIV while on SCIG.
- Lack of consent by parent/guardian (if required by Institution/IRB).
- Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.
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 |
|---|---|---|
| Subcutaneous IgG (SCIG)Also: Vivaglobin, SCIGAdministered according to normal clinical practice | Biological | SCIG |
Primary outcome
SCIG use
Time frame: 1 year
To describe the use of SCIG in infants below the age of two years in major academic medical centers and immunologists' practices in the US
1 secondary outcome
Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC
Time frame: 1 year
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 11 Feb 2011.
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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.
Melvin Berger, MD, PhD principal investigator
CSL Behring
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Deficiency, run by CSL Behring at 5 sites in United States.
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 2 inclusion and 4 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 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
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?
SCIG use (time frame: 1 year). 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 11 Feb 2011.