Primary Immunodeficiency Diseases (PID)Phase 2NCT00161993
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
A Phase 2 study testing Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution and Gammagard S/D (Solvent/Detergent) in people with Primary Immunodeficiency Diseases (PID) and Agammaglobulinemia, run by Baxalta now part of Shire at 6 sites in 2 countries.
Trial summary
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID), Agammaglobulinemia, Hypogammaglobulinemia
- What is being tested?
- Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution and Gammagard S/D (Solvent/Detergent)
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 13 Jun 2002to 24 Sep 2003
- Phase
- Phase 2
- 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
- Subjects will be eligible for study entry if they:
- are at least 18 years old
- have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
- have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
- have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
- if female of childbearing potential, agree to employ adequate birth control measures during the study
- have given written informed consent
Who cannot join
- Subjects will not be eligible for study entry if they:
- had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
- suffer from documented selective IgA deficiency with antibodies against IgA
- have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
- are known to be infected with HIV, HCV, or HBV
- are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
Show all 10Show fewer
- suffer from congestive heart failure and receive on-demand treatment with furosemide
- show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
- received another investigational drug in the three weeks preceding study entry
- in case of females, are pregnant or nursing mothers
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Sweden4 sites
SU/Sahlgrenska
Gothenburg, 41345
University Hospital Lund
Lund, 221 85
University Hospital MAS
Malmö, 205 02
Sundsvall Hospital
Sundsvall, 851 86
Finland2 sites
Tampere University Hospital
Tampere, 33 521
Turku University Central Hospital
Turku, 205 20
About this study
Official title: Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
- Being tested
- Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution, Gammagard S/D (Solvent/Detergent)
- Keywords
- Gammaglobulin
- Medical subject headings
- Primary Immunodeficiency Diseases, Agammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) SolutionDrug
Gammagard S/D (Solvent/Detergent)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
Measured: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study start13 Jun 2002
- Primary completion24 Sep 2003
- Study completion24 Sep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161993
- Sponsor's protocol ID
- 160001
- Status last verified
- Aug 2021
- First submitted
- 8 Sep 2005
- Last updated
- 24 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia
- ClinicalTrials.gov ID
- NCT00161993
- Acronym / sponsor ID
- 160001
- Keywords
- Gammaglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2002 (actual)
- Primary completion
- 24 Sep 2003 (actual)
- Study completion
- 24 Sep 2003 (actual)
- First posted
- 13 Sep 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 purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
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 (7 listed)
- are at least 18 years old
- have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
- have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
- have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
- if female of childbearing potential, agree to employ adequate birth control measures during the study
Key exclusion criteria (10 listed)
- had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
- suffer from documented selective IgA deficiency with antibodies against IgA
- have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
- are known to be infected with HIV, HCV, or HBV
- are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
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 |
|---|---|---|
| Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution | Drug | – |
| Gammagard S/D (Solvent/Detergent) | Drug | – |
Primary outcome
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
Time frame: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit
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 24 Aug 2021.
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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.
Study Director study director
Takeda
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution and Gammagard S/D (Solvent/Detergent) in people with Primary Immunodeficiency Diseases (PID) and Agammaglobulinemia, run by Baxalta now part of Shire at 6 sites in 2 countries.
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 7 inclusion and 10 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 24 Aug 2021. 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 Sweden, Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution) (time frame: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit). 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 24 Aug 2021.