Primary Immune Deficiency DisorderNCT01859754
Octagam 5% Versus Comparator Post Marketing Trial
An observational study of Primary Immune Deficiency Disorder, run by Octapharma at 27 sites in United States.
Trial summary
Study Design: This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Deficiency Disorder
- What is being tested?
- Octagam 5% and Other marketed IVIG product
- Type of treatment
- Injection or infusion
- How many people
- 623 participants
- Where
- 27 sitesUnited States
- Study dates
- 21 May 2013to 22 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment
Who may be able to join
- Male and female patients aged 18 years.
- Patients with confirmed diagnosis of Primary Humoral Immunodeficiency (PI) as stated by the World Health Organization and requiring immunoglobulinreplacement therapy due to hypogammaglobulinemia or agammaglobulinemia.
- Patients on regular treatment (every 3 to 4 weeks) with low dose IGIV (1 g/kg) for a period of at least 6 months without changing the brand.
Who cannot join
- Patients with a history of TEEs within the previous 24 months.
- Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Octapharma Research Site
Amarillo, Texas, 79124
Octapharma Research Site
Anderson, South Carolina, 29621
Octapharma Research Site
Centennial, Colorado, 80112
Octapharma Research Site
Chicago, Illinois, 60612
Octapharma Research Site
Columbus, Ohio, 43235
Octapharma Research Site
Dallas, Texas, 75231
Octapharma Research Site
East Setauket, New York, 11733
Octapharma Research Site
Farmington Hills, Michigan, 48334
Octapharma Research Site
Fort Mitchell, Kentucky, 41017
Octapharma Research Site
Fort Wayne, Indiana, 46815
Octapharma Research Site
Granada Hills, California, 91344
Octapharma Research Site
Irvine, California, 92697
Octapharma Research Site
Irving, Texas, 75014
Octapharma Research Site
Los Angeles, California, 90025
Octapharma Research Site
Mayfield Heights, Ohio, 44124
Octapharma Research Site
Nashville, Tennessee, 37203
Octapharma Research Site
New York, New York, 10012
Octapharma Research Site
New York, New York, 10065
Octapharma Research Site
Omaha, Nebraska, 68124
Octapharma Research Site
Pawtucket, Rhode Island, 02860
Octapharma Research Site
Plymouth, Minnesota, 55446
Octapharma Research Site
Plymouth, Minnesota, 55447
Octapharma Research Site
Redlands, California, 92373
Octapharma Research Site
Roswell, Georgia, 30076
Octapharma Research Site
Springfield, Illinois, 62701
Octapharma Research Site
Toledo, Ohio, 43617
Octapharma Research Site
Wichita, Kansas, 67201
About this study
Official title: Postmarketing Requirement Non-Interventional 2-armed Study to Evaluate the Safety of Octagam® Immune Globulin Intravenous (Human) 5% Liquid Preparation, With a Special Emphasis on Monitoring, Analysis and Reporting of Thromboembolic Events
Study Design:
This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.
Read the detailed description
This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.
The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use.
- Conditions
- Primary Immune Deficiency Disorder
- Being tested
- Octagam 5%, Other marketed IVIG product
- Keywords
- Primary Immune Deficiency Syndrome, Primary immunodeficiency Disease (PIDD), PID
- 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.
Octagam 5%Biological
Intravenous immunoglobulin 5%
Other marketed IVIG productBiological
Any intravenous immunoglobulin marketed product approved for the treatment of PID
| Study group | Role | What they receive |
|---|---|---|
| Octagam 5% | Primary Immune Deficiency Syndrome patients receiving Octagam 5% by infusion who have been treated with a marketed IVIG product for at least 6 months. Receives: Biological: Octagam 5% | |
| Other marketed IVIG product | Primary Immune Deficiency Syndrome patients receiving marketed IVIG product other than Octagam 5% by infusion as treatment for at least 6 months. Receives: Biological: Other marketed IVIG product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Thromboembolytic events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study start21 May 2013
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Frenzel, Principal investigator, International Medical Monitor, Octapharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859754
- Sponsor's protocol ID
- GAM5-28
- Status last verified
- Jun 2019
- First submitted
- 9 May 2013
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Requirement Non-Interventional 2-armed Study to Evaluate the Safety of Octagam® Immune Globulin Intravenous (Human) 5% Liquid Preparation, With a Special Emphasis on Monitoring, Analysis and Reporting of Thromboembolic Events
- ClinicalTrials.gov ID
- NCT01859754
- Acronym / sponsor ID
- GAM5-28
- Conditions
- Primary Immune Deficiency Disorder
- Keywords
- Primary Immune Deficiency Syndrome, Primary immunodeficiency Disease (PIDD), PID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 21 May 2013 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 22 May 2013 (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.
Study Design:
This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.
Detailed description
This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.
The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octagam 5% | – | Biological: Octagam 5%Primary Immune Deficiency Syndrome patients receiving Octagam 5% by infusion who have been treated with a marketed IVIG product for at least 6 months. |
| Other marketed IVIG product | – | Biological: Other marketed IVIG productPrimary Immune Deficiency Syndrome patients receiving marketed IVIG product other than Octagam 5% by infusion as treatment for at least 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment
Key inclusion criteria (3 listed)
- Male and female patients aged 18 years.
- Patients with confirmed diagnosis of Primary Humoral Immunodeficiency (PI) as stated by the World Health Organization and requiring immunoglobulinreplacement therapy due to hypogammaglobulinemia or agammaglobulinemia.
- Patients on regular treatment (every 3 to 4 weeks) with low dose IGIV (1 g/kg) for a period of at least 6 months without changing the brand.
Key exclusion criteria (2 listed)
- Patients with a history of TEEs within the previous 24 months.
- Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
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 |
|---|---|---|
| Octagam 5%Intravenous immunoglobulin 5% | Biological | Octagam 5% |
| Other marketed IVIG productAny intravenous immunoglobulin marketed product approved for the treatment of PID | Biological | Other marketed IVIG product |
Primary outcome
Incidence Rate of Thromboembolytic events
Time frame: 4 months
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 10 Jun 2019.
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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.
Wolfgang Frenzel principal investigator
International Medical Monitor, Octapharma AG
27 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 Disorder, run by Octapharma at 27 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 3 inclusion and 2 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
Incidence Rate of Thromboembolytic events (time frame: 4 months). 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 10 Jun 2019.