Primary Antibody DeficiencyPhase 3NCT02247141
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
A Phase 3 study testing Subgam® (Human Normal Immunoglobulin Solution) in people with Primary Antibody Deficiency, run by Bio Products Laboratory at 14 sites in United Kingdom.
Trial summary
The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Antibody Deficiency
- What is being tested?
- Subgam® (Human Normal Immunoglobulin Solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 14 sitesUnited Kingdom
- Study dates
- Jun 2000to Jan 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The main criteria for inclusion in the study were as follows:
- A diagnosis of primary antibody deficiency;
- No lower or upper age limit (any age was eligible);
- With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
- Written informed consent (patient/parent/guardian).
Who cannot join
- -
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Birmingham Children's Hospital
Birmingham
University Hospital of Wales
Cardiff
Guest Hospital
Dudley, West Midlands
St James' University Hospital
Leeds
Leicester Royal Infirmary
Leicester
Great Ormond Street Hospital
London
St Bartholomew's Hospital
London
John Radcliffe Hospital
Oxford
Papworth Hospital
Papworth Everard, Cambridgeshire
Royal Preston Hospital
Preston, Lancashire
Hope Hospital
Salford
Northern General Hospital
Sheffield
Southampton General Hospital
Southampton
St Helier Hospital, Carshalton
Surrey
About this study
Official title: A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.
The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.
The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.
- Conditions
- Primary Antibody Deficiency
- Being tested
- Subgam® (Human Normal Immunoglobulin Solution)
- 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.
Subgam® (Human Normal Immunoglobulin Solution)Biological
| Study group | Role | What they receive |
|---|---|---|
| Subgam® | Experimental | Not described Receives: Biological: Subgam® (Human Normal Immunoglobulin Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
Measured: Before each infusion in the first 6 months of the study (approximately 30 infusions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startJun 2000
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Antibody 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 3
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247141
- Sponsor's protocol ID
- SCIG01
- Status last verified
- Jan 2018
- First submitted
- 2 Sep 2014
- Last updated
- 24 Jan 2018
- Results posted
- No
Publications
Dash C, Gascoigne E, Gillanders K, Gooi H. Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141). PLoS One. 2015 Jul 29;10(7):e0131565. doi: 10.1371/journal.pone.0131565. eCollection 2015.
PubMed 26222441
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.
- ClinicalTrials.gov ID
- NCT02247141
- Acronym / sponsor ID
- SCIG01
- Conditions
- Primary Antibody Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Jun 2000
- Primary completion
- Jan 2005 (actual)
- First posted
- 23 Sep 2014 (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 primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.
The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subgam® | Experimental | Biological: Subgam® (Human Normal Immunoglobulin Solution) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The main criteria for inclusion in the study were as follows:
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Subgam® (Human Normal Immunoglobulin Solution) | Biological | Subgam® |
Primary outcome
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
Time frame: Before each infusion in the first 6 months of the study (approximately 30 infusions)
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 Jan 2018.
- Derived from this study: PubMed 26222441Dash C, Gascoigne E, Gillanders K, Gooi H. Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141). PLoS One. 2015 Jul 29;10(7):e0131565. doi: 10.1371/journal.pone.0131565. eCollection 2015.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 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 Subgam® (Human Normal Immunoglobulin Solution) in people with Primary Antibody Deficiency, run by Bio Products Laboratory at 14 sites in United Kingdom.
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 1 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. 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?
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L (time frame: Before each infusion in the first 6 months of the study (approximately 30 infusions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02247141, which also lists 1 linked publication.
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 Jan 2018.