Primary ImmunodeficiencyPhase 3NanogamNCT01985373
Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
A Phase 3 study testing Intravenous immunoglobulin infusion in people with Primary Immunodeficiency, run by Prothya Biosolutions at 4 sites in Netherlands.
Trial summary
Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiency
- What is being tested?
- Intravenous immunoglobulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesNetherlands
- Study dates
- Dec 2013to Mar 2015
- 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
- Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
- Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
- A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
- Age >= 18 years
- The patient has signed the consent form
Who cannot join
- Known with allergic reactions against human plasma or plasma products
- Having an ongoing progressive disease, including HIV infection
- Pregnancy or lactation
- Known with insufficiency of coronary or cerebral circulation
- Having renal insufficiency (plasma creatinin > 115µmol/L)
- Having IgA deficiency and anti-IgA antibodies have been detected
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
UMCG
Groningen
LUMC
Leiden
UMC St. Radboud
Nijmegen
About this study
Official title: Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml
Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.
- Conditions
- Primary Immunodeficiency
- Being tested
- Intravenous immunoglobulin infusion
- Keywords
- intravenous immunoglobulin, pharmacokinetics, 10% IVIG
- 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.
Intravenous immunoglobulin infusionDrug
Also called Nanogam
Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK
| Study group | Role | What they receive |
|---|---|---|
| Intravenous immunoglobulin infusion | Experimental | One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg) Receives: Drug: Intravenous immunoglobulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG trough levels
Comparison IVIG 5% and 10%
Measured: before infusion
plasma concentration-time curve
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
half-life
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
area under the curve
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
volume of distribution
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Cmax
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Tmax
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
elimination rate constant(s)
Comparison IVIG 5% and 10%
Measured: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Secondary outcomes (1)
Adverse Events
number and type
Measured: from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ImmunodeficiencyStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- F P Kroon, PhD, MD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985373
- Sponsor's protocol ID
- MD2012.02
- Other IDs
- 2012-005727-32
- Acronym
- Nanogam
- Status last verified
- Apr 2015
- First submitted
- 31 Oct 2013
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml
- ClinicalTrials.gov ID
- NCT01985373
- Acronym / sponsor ID
- Nanogam / MD2012.02
- Conditions
- Primary Immunodeficiency
- Keywords
- intravenous immunoglobulin, pharmacokinetics, 10% IVIG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Nov 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.
Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous immunoglobulin infusion | Experimental | Drug: Intravenous immunoglobulin infusionOne intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
- Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
- A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
- Age >= 18 years
- The patient has signed the consent form
Key exclusion criteria (6 listed)
- Known with allergic reactions against human plasma or plasma products
- Having an ongoing progressive disease, including HIV infection
- Pregnancy or lactation
- Known with insufficiency of coronary or cerebral circulation
- Having renal insufficiency (plasma creatinin > 115µmol/L)
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 infusionAlso: NanogamBlood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK | Drug | Intravenous immunoglobulin infusion |
Primary outcome
IgG trough levels
Time frame: before infusion
Comparison IVIG 5% and 10%
plasma concentration-time curve
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
half-life
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
area under the curve
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
volume of distribution
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
Cmax
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
Tmax
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
elimination rate constant(s)
Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
1 secondary outcome
Adverse Events
Time frame: from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)
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 6 Apr 2015.
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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.
F P Kroon, PhD, MD principal investigator
LUMC
4 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 Intravenous immunoglobulin infusion in people with Primary Immunodeficiency, run by Prothya Biosolutions at 4 sites in Netherlands.
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 5 inclusion and 6 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 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
IgG trough levels (time frame: before infusion). The study lists 8 primary outcomes in all. 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 6 Apr 2015.