HypogammaglobulinemiaPhase 2/3NCT00138697
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
A Phase 2/3 study testing IVIG-L in people with Hypogammaglobulinemia, run by Prothya Biosolutions at 6 sites in Netherlands.
Trial summary
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypogammaglobulinemia
- What is being tested?
- IVIG-L
- How many people
- 15 participants
- Where
- 6 sitesNetherlands
- Study dates
- May 2001to Dec 2004
- Phase
- Phase 2/3
- 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 X-linked agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID)
- Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals
- A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose)
- Age > 18 years
- The patient/legally acceptable representative has signed the consent form
Who cannot join
- Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- Known allergic reactions to human plasma or plasma products
- Have an ongoing progressive terminal disease, including HIV infection
- Pregnancy or lactation
- Known insufficiency of coronary or cerebral circulation
- Have renal insufficiency (plasma creatinine > 115µmol/L)
Show all 9Show fewer
- Have an ongoing active disease causing general symptoms, e.g. chronic active hepatitis, persistent enterovirus infection.
- Have IgA deficiency, and anti-IgA antibodies have been detected
- Active systemic lupus erythematosus (SLE)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Medical Centre Alkmaar
Alkmaar, 1815 JD
Academic Medical Centre
Amsterdam, 1100 DD
Academic Hospital Groningen
Groningen, 9700 RB
LUMC
Leiden, 2333 ZA
UMC St. Radboud
Nijmegen, 6525 GA
Leyenburg Hospital
The Hague, 2545 CH
About this study
Official title: Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.
Read the detailed description
Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage.
In addition to the donor selection and donor screening, several viral safety steps have been included into the production process.
In this clinical trial, the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic ITP (KB98001). Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands.
- Conditions
- Hypogammaglobulinemia
- Being tested
- IVIG-L
- Keywords
- Agammaglobulinemia, Hypogammaglobulinemia, Immunoglobulins, Intravenous
- Medical subject headings
- Agammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG-LDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of IVIG-L in patients with hypogammaglobulinemia
Efficacy of IVIG-L in patients with hypogammaglobulinemia
Safety of IVIG-L in patients with hypogammaglobulinemia
Secondary outcomes (2)
To compare the IgG trough level
To compare dosage and treatment intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMay 2001
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogammaglobulinemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J WM van der Meer, MD, PhD, Principal investigator, UMC St Radboud Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138697
- Sponsor's protocol ID
- KB97003 (A & B)
- Status last verified
- Apr 2007
- First submitted
- 29 Aug 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
- ClinicalTrials.gov ID
- NCT00138697
- Acronym / sponsor ID
- KB97003 (A & B)
- Conditions
- Hypogammaglobulinemia
- Keywords
- Agammaglobulinemia, Hypogammaglobulinemia, Immunoglobulins, Intravenous
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Study completion
- Dec 2004 (actual)
- First posted
- 30 Aug 2005 (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.
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.
Detailed description
Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage.
In addition to the donor selection and donor screening, several viral safety steps have been included into the production process.
In this clinical trial, the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic ITP (KB98001). Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 X-linked agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID)
- Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals
- A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose)
- Age > 18 years
- The patient/legally acceptable representative has signed the consent form
Key exclusion criteria (9 listed)
- Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- Known allergic reactions to human plasma or plasma products
- Have an ongoing progressive terminal disease, including HIV infection
- Pregnancy or lactation
- Known insufficiency of coronary or cerebral circulation
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 |
|---|---|---|
| IVIG-L | Drug | – |
Primary outcome
Kinetics of IVIG-L in patients with hypogammaglobulinemia
Efficacy of IVIG-L in patients with hypogammaglobulinemia
Safety of IVIG-L in patients with hypogammaglobulinemia
2 secondary outcomes
To compare the IgG trough level
To compare dosage and treatment intervals
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 19 Apr 2007.
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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.
J WM van der Meer, MD, PhD principal investigator
UMC St Radboud Nijmegen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IVIG-L in people with Hypogammaglobulinemia, run by Prothya Biosolutions at 6 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 9 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 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Kinetics of IVIG-L in patients with hypogammaglobulinemia. The study lists 3 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 19 Apr 2007.