IgG DeficiencyPhase 4SubklasseNCT00522821
Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response
A Phase 4 study testing intravenous immunoglobulins and antibiotics in people with IgG Deficiency and Infections, run by Prothya Biosolutions at 9 sites in Netherlands.
Trial summary
There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- IgG Deficiency, Infections
- What is being tested?
- intravenous immunoglobulins and antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 9 sitesNetherlands
- Study dates
- Nov 2007to Jul 2014
- Phase
- Phase 4
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency
- At least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.
- Total serum IgG > 4 g/l
- ≥ 5 years of age
- Informed consent
Who cannot join
- Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study
- Allergic reactions against human plasma/plasma products, or co-trimoxazole
- An ongoing progressive terminal disease
- Pregnancy or lactation
- History of (transient) cerebrovascular accident or coronary insufficiency
- Renal insufficiency (plasma creatinin > 115 µmol/L; or creatinin clearance <20 ml/min)
Show all 10Show fewer
- An ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints
- Detectable anti-IgA antibodies
- Active systemic lupus erythematosus (SLE)
- Glucose-6-phosphate hydrogenase deficiency
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
AMC
Amsterdam
VU
Amsterdam
UMCG
Groningen
LUMC
Leiden
AZM
Maastricht
UMC St Radboud
Nijmegen
Erasmus MC
Rotterdam
UMCU
Utrecht
About this study
Official title: Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response
There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Therefore, the Dutch Inter University Working Party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.
Read the detailed description
There is no consensus on the treatment of patients with recurrent infections and isolated IgG-subclass deficiency and/or selective antipolysaccharide antibody deficiency. At present, there are no robust criteria to predict which patient will or will not respond adequately to antibiotic treatment or to IVIG. Furthermore, it is unknown whether IVIG treatment improves the quality of life in these patients. Therefore, the Dutch InterUniversity Working Party intends to start a study in this patient group. In this study, treatment for a year with antibiotics will be compared with a year intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.
The patient will visit the clinic every 3 months during which laboratory tests and physiological measurements will be performed. Moreover the occurrence of infections and fever, the use of antibiotics, hospital admissions, and quality of life will be documented.
The study should result in a national harmonization in the treatment of this patient group. To this end, the results of the study will be used to compile a treatment protocol for this group of patients in the Netherlands and if applicable also in other countries worldwide.
- Conditions
- IgG Deficiency, Infections
- Being tested
- intravenous immunoglobulins, antibiotics
- Keywords
- IgG subclass deficiency, Anti-polysaccharide deficiency, therapy, Immunoglobulins, Intravenous, co-trimoxazole
- Medical subject headings
- IgG Deficiency, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulinsDrug
Also called Nanogam
- Adults: 600 mg/kg bodyweight every 3 weeks
- Children: 800 mg/kg bodyweight every 3 week
antibioticsDrug
Also called co-trimoxazol, if not lorated: azitromycine
- Children ≥5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid.
- Adults and children ≥12 years or ≥40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Other | A: co-trimoxazole prophylactically for 12 months followed by intravenous immunoglobulin treatment for 12 months.
Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given. Receives: Drug: intravenous immunoglobulins; Drug: antibiotics |
| intravenous immunoglobulins | Other | B: intravenous immunoglobulin treatment for 12 months followed by co-trimoxazole prophylactically for 12 months.
Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given. Receives: Drug: intravenous immunoglobulins; Drug: antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections.
Measured: 27 months
Secondary outcomes (1)
Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG DeficiencyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J T van Dissel, PhD, MD, Principal investigator, LUMCT W Kuijpers, PhD, MD, Principal investigator, AIDS Malignancy ConsortiumE AM Sanders, PhD, MD, Principal investigator, UMCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522821
- Sponsor's protocol ID
- IUWP2005.01
- Acronym
- Subklasse
- Status last verified
- Apr 2015
- First submitted
- 29 Aug 2007
- 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
- Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response
- ClinicalTrials.gov ID
- NCT00522821
- Acronym / sponsor ID
- Subklasse / IUWP2005.01
- Conditions
- IgG Deficiency, Infections
- Keywords
- IgG subclass deficiency, Anti-polysaccharide deficiency, therapy, Immunoglobulins, Intravenous, co-trimoxazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Aug 2007 (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.
There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Therefore, the Dutch Inter University Working Party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.
Detailed description
There is no consensus on the treatment of patients with recurrent infections and isolated IgG-subclass deficiency and/or selective antipolysaccharide antibody deficiency. At present, there are no robust criteria to predict which patient will or will not respond adequately to antibiotic treatment or to IVIG. Furthermore, it is unknown whether IVIG treatment improves the quality of life in these patients. Therefore, the Dutch InterUniversity Working Party intends to start a study in this patient group. In this study, treatment for a year with antibiotics will be compared with a year intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.
The patient will visit the clinic every 3 months during which laboratory tests and physiological measurements will be performed. Moreover the occurrence of infections and fever, the use of antibiotics, hospital admissions, and quality of life will be documented.
The study should result in a national harmonization in the treatment of this patient group. To this end, the results of the study will be used to compile a treatment protocol for this group of patients in the Netherlands and if applicable also in other countries worldwide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Other | Drug: intravenous immunoglobulins, Drug: antibioticsA: co-trimoxazole prophylactically for 12 months followed by intravenous immunoglobulin treatment for 12 months. Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given. |
| intravenous immunoglobulins | Other | Drug: intravenous immunoglobulins, Drug: antibioticsB: intravenous immunoglobulin treatment for 12 months followed by co-trimoxazole prophylactically for 12 months. Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency
- At least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.
- Total serum IgG > 4 g/l
- ≥ 5 years of age
- Informed consent
Key exclusion criteria (10 listed)
- Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study
- Allergic reactions against human plasma/plasma products, or co-trimoxazole
- An ongoing progressive terminal disease
- Pregnancy or lactation
- History of (transient) cerebrovascular accident or coronary insufficiency
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 immunoglobulinsAlso: Nanogam* Adults: 600 mg/kg bodyweight every 3 weeks * Children: 800 mg/kg bodyweight every 3 week | Drug | Antibiotics, intravenous immunoglobulins |
| antibioticsAlso: co-trimoxazol, if not lorated: azitromycine* Children ≥5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid. * Adults and children ≥12 years or ≥40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid. | Drug | Antibiotics, intravenous immunoglobulins |
Primary outcome
the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections.
Time frame: 27 months
1 secondary outcome
Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.
Time frame: 27 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 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.
J T van Dissel, PhD, MD principal investigator
LUMC
T W Kuijpers, PhD, MD principal investigator
AIDS Malignancy Consortium
E AM Sanders, PhD, MD principal investigator
UMCU
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous immunoglobulins and antibiotics in people with IgG Deficiency and Infections, run by Prothya Biosolutions at 9 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 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 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 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections. (time frame: 27 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 6 Apr 2015.