Primary ImmunodeficiencyPhase 3NCT03907241
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
A Phase 3 study testing Octanorm 16.5% in people with Primary Immunodeficiency, run by Octapharma at 7 sites in 2 countries.
Trial summary
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01 trial. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Primary Immunodeficiency
- What is being tested?
- Octanorm 16.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Mar 2016to 5 Sep 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completion of the main study SCGAM-01, with good tolerance of Octanorm (as determined by the investigator).
- For adult patients: freely given written informed consent. For patients below the legal age of majority: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with local requirements.
- For female patients of child-bearing potential, a negative result in a urine pregnancy test conducted at the Screening visit.
- Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
- Either:
- SCGAM-01 patients (United States, Canada):
Show all 16Show fewer
- 1. Completion of the main study SCGAM-01, with good tolerance of octanorm (as determined by the investigator).
- Or:
- De novo patients (Canada only):
- C-a Age of ≥18 years and ≤75 years.
- 1C-b Confirmed diagnosis of PI as defined by ESID and PAGID and requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The exact type of PI should be recorded.
- C-c Availability of the IgG trough levels of 2 previous SCIG infusions before enrolment, and maintenance of ≥5.0 g/L in the trough levels of these 2 previous infusions.
- And:
- 2. For adult patients: freely given written informed consent. For patients below the legal age of majority: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with local requirements.
- 3. For female patients of child-bearing potential, a negative result in a urine pregnancy test conducted at the Screening Visit.
- 4. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
Who cannot join
- Subject being without any IgG treatment for period greater than approximately 5 weeks between the last infusion of Octanorm in the SCGAM-01 study and the first infusion of Octanorm in the SCGAM-03 study.
- Exposure to blood or any blood product or derivative, other than IgG used for regular PID treatment, within the 3 months before the first infusion in this study.
- Planned pregnancy during the course of the study.
- Either:
- SCGAM-01 patients (United States, Canada):
- 1 Subject being without any IgG treatment for period greater than 5 weeks between the last infusion of octanorm in the SCGAM-01 study and the first infusion of octanorm in the SCGAM-03 study.
Show all 27Show fewer
- Or:
- De novo patients (Canada only):
- 1C-a Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
- 1C-b Known history of adverse reactions to IgA in other products.
- 1C-c Patients with body mass index >40 kg/m2.
- 1C-d Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product (such as Polysorbate 80).
- 1C-e Requirement of any routine premedication for IgG administration.
- 1C-f History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
- 1C-g Severe liver function impairment (ALAT 3 times above upper limit of normal).
- 1C-h Known protein-losing enteropathies or proteinuria.
- 1C-i Presence of renal function impairment (creatinine >120 μM/L or creatinine >1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
- 1C-j Treatment with oral or parenteral steroids for ≥30 days or when given intermittently or as bolus at daily doses ≥0.15 mg/kg.
- 1C-k Treatment with immunosuppressive or immunomodulatory drugs.
- 1C-l Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
- And:
- 2. Exposure to blood or any blood product or plasma derivatives, other than SCIG used for regular PID treatment, within the 3 months before the first infusion of octanorm in this study.
- 3. Pregnant or nursing women or planned pregnancy during the course of the study.
- 4. Treatment with any investigational medicinal product (other than that of SCGAM-01) within 3 months prior to first infusion of octanorm.
- 5. Presence of any condition, that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
- 6. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
- 7. Known or suspected HIV, HCV, or HBV infection.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Octapharma Research Site
Centennial, Colorado, 80112
Octapharma Research Site
Frisco, Texas, 75034
Octapharma Research Site
Irvine, California, 92697
Octapharma Research Site
Papillion, Nebraska, 68046
Octapharma Research Site
San Diego, California, 92123
Octapharma Research Site
Toledo, Ohio, 43617
About this study
Official title: Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01 trial.
Summary for SCGAM-03 in Canada: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases, including (but not limited to) those who have completed the SCGAM-01 trial
- Conditions
- Primary Immunodeficiency
- Being tested
- Octanorm 16.5%
- 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.
Octanorm 16.5%Drug
Human normal immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| Octanorm 16.5% | Experimental | octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration. Receives: Drug: Octanorm 16.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of All Treatment-emergent Adverse Events (TEAEs)
Number of TEAEs
Measured: From study start to end, up to 3.5 years
Occurrence of Temporally Associated TEAEs
Measured: From study start to end, up to 3.5 years
Number of Temporally Associated TEAEs by Infusion Rate
Number of temporally associated TEAEs by infusion rate. Only includes systemic TEAEs without infections and without infusion site reactions
Measured: From study start to end, up to 3.5 years
Local Injection-site Reactions
Measured: From study start to end, up to 3.5 years
Blood Pressure
Systolic and diastolic.
Measured: From study start to end, up to 3.5 years
Body Temperature
Measured: From study start to end, up to 3.5 years
Respiratory Rate
Measured: From study start to end, up to 3.5 years
Sodium
Changes in sodium levels from baseline to end of study
Measured: From study start to end, up to 3.5 years
Potassium
Changes in potassium levels from baseline to end of study
Measured: From study start to end, up to 3.5 years
Blood Glucose
Changes in blood glucose from baseline to end of study
Measured: From study start to end, up to 3.5 years
ALAT
Changes in ALAT (alanine transaminase) from baseline to end of study
Measured: From study start to end, up to 3.5 years
ASAT
Changes in ASAT (aspartate aminotransferase) from baseline to end of study
Measured: From study start to end, up to 3.5 years
LDH
Changes in LDH (lactate dehydrogenase) from baseline to end of study
Measured: From study start to end, up to 3.5 years
Total Bilirubin
Changes in total bilirubin from baseline to end of study
Measured: From study start to end, up to 3.5 years
Blood Urea Nitrogen
Changes in blood urea nitrogen from baseline to end of study
Measured: From study start to end, up to 3.5 years
Creatinine
Changes in creatinine from baseline to end of study
Measured: From study start to end, up to 3.5 years
Urine pH
Changes in urine pH from baseline to end of study
Measured: From study start to end, up to 3.5 years
Number of Participants With a Change in Urine Glucose
Number of Participants with a Change in Urine Glucose
Measured: From study start to end, up to 3.5 years
Number of Participants With a Change in Urine Ketones
Number of Participants With a Change in Urine Ketones at baseline and end of study
Measured: From study start to end, up to 3.5 years
Number of Participants With a Change in Urine Leukocytes
Number of participants with a change in urine leukocytes at baseline and end of study
Measured: From study start to end, up to 3.5 years
Number of Participants With a Change in Urine Hemoglobin
Number of participants with a change in urine hemoglobin at baseline and end of study
Measured: From study start to end, up to 3.5 years
Complete Red Blood Cell Count
Changes in complete red blood cell count from baseline to end of study
Measured: From study start to end, up to 3.5 years
Haematocrit
Changes in haematocrit from baseline to end of study
Measured: From study start to end, up to 3.5 years
Haemoglobin
Changes in haemoglobin from baseline to end of study
Measured: From study start to end, up to 3.5 years
Complete White Blood Cell Count
Changes in complete white blood cell count from baseline to end of study
Measured: From study start to end, up to 3.5 years
Secondary outcomes (4)
Measurement of Trough Total IgG Levels
Measurement of trough total IgG levels from baseline to end of study
Measured: From study start to end, up to 3.5 years
Number of Participants With Serious Bacterial Infections (SBIs).
Number of participants with serious bacterial infections
Measured: From study start to end, up to 3.5 years
SF-36 Health Survey.
Quality of Life for patients >= age 14 assessed using the Short Form 36 Health survey. Likert like scale.
The responses given by patients were combined to create 8 SF-36 scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health
36 questions that fall into 4 Sub scale scoring ranges: Score 1-5: Where 1 is more favorable than 5 Score 1-3: Where 3 is more favorable than 1 Score 1-5: Where 5 is more favorable than 1 Score 1-6: Where 1 is more favorable than 6 The raw subscale scores are converted into a scale score between 0 to 100 using the Quality Metric Health Outcomes™ Scoring Software 2.0 Scale Title of final scales is: Physical and Mental Health Component Summary Scores Range: Lowest = 0 and highest = 100 where a high score equates to a more favorable health state
Measured: From study start to end, up to 3.5 years
CHQ-PF50 (Child Health Questionnaire-Parent Form)
Quality of Life for patients ages <14 years assessed using the CHQ-PF50. Measured values represent change in score from baseline to end of study.
Two summary scores were derived: physical and psychosocial. In accord with the scoring manual, computed scores were transformed giving each scale a possible range from 0 to 100, with the exception of change in health, with a possible range from 1 to 5. For all CHQ-PF50 scales, higher scores indicated more positive functioning or better health status.
Measured: From study start to end, up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Mar 2016
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907241
- Sponsor's protocol ID
- SCGAM-03 -
- Status last verified
- Oct 2020
- First submitted
- 7 Dec 2018
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
- ClinicalTrials.gov ID
- NCT03907241
- Acronym / sponsor ID
- SCGAM-03 -
- Conditions
- Primary Immunodeficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Posted 22 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01 trial.
Summary for SCGAM-03 in Canada: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases, including (but not limited to) those who have completed the SCGAM-01 trial
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Octanorm 16.5% | Experimental | Drug: Octanorm 16.5%octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Completion of the main study SCGAM-01, with good tolerance of Octanorm (as determined by the investigator).
- For adult patients: freely given written informed consent. For patients below the legal age of majority: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with local requirements.
- For female patients of child-bearing potential, a negative result in a urine pregnancy test conducted at the Screening visit.
- Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
- 1. Completion of the main study SCGAM-01, with good tolerance of octanorm (as determined by the investigator).
Key exclusion criteria (27 listed)
- Subject being without any IgG treatment for period greater than approximately 5 weeks between the last infusion of Octanorm in the SCGAM-01 study and the first infusion of Octanorm in the SCGAM-03 study.
- Exposure to blood or any blood product or derivative, other than IgG used for regular PID treatment, within the 3 months before the first infusion in this study.
- Planned pregnancy during the course of the study.
- Either:
- 1 Subject being without any IgG treatment for period greater than 5 weeks between the last infusion of octanorm in the SCGAM-01 study and the first infusion of octanorm in the SCGAM-03 study.
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 |
|---|---|---|
| Octanorm 16.5%Human normal immunoglobulin | Drug | Octanorm 16.5% |
Primary outcome
Occurrence of All Treatment-emergent Adverse Events (TEAEs)
Time frame: From study start to end, up to 3.5 years
Number of TEAEs
Occurrence of Temporally Associated TEAEs
Time frame: From study start to end, up to 3.5 years
Number of Temporally Associated TEAEs by Infusion Rate
Time frame: From study start to end, up to 3.5 years
Number of temporally associated TEAEs by infusion rate. Only includes systemic TEAEs without infections and without infusion site reactions
Local Injection-site Reactions
Time frame: From study start to end, up to 3.5 years
Blood Pressure
Time frame: From study start to end, up to 3.5 years
Systolic and diastolic.
Body Temperature
Time frame: From study start to end, up to 3.5 years
Respiratory Rate
Time frame: From study start to end, up to 3.5 years
Sodium
Time frame: From study start to end, up to 3.5 years
Changes in sodium levels from baseline to end of study
Potassium
Time frame: From study start to end, up to 3.5 years
Changes in potassium levels from baseline to end of study
Blood Glucose
Time frame: From study start to end, up to 3.5 years
Changes in blood glucose from baseline to end of study
ALAT
Time frame: From study start to end, up to 3.5 years
Changes in ALAT (alanine transaminase) from baseline to end of study
ASAT
Time frame: From study start to end, up to 3.5 years
Changes in ASAT (aspartate aminotransferase) from baseline to end of study
LDH
Time frame: From study start to end, up to 3.5 years
Changes in LDH (lactate dehydrogenase) from baseline to end of study
Total Bilirubin
Time frame: From study start to end, up to 3.5 years
Changes in total bilirubin from baseline to end of study
Blood Urea Nitrogen
Time frame: From study start to end, up to 3.5 years
Changes in blood urea nitrogen from baseline to end of study
Creatinine
Time frame: From study start to end, up to 3.5 years
Changes in creatinine from baseline to end of study
Urine pH
Time frame: From study start to end, up to 3.5 years
Changes in urine pH from baseline to end of study
Number of Participants With a Change in Urine Glucose
Time frame: From study start to end, up to 3.5 years
Number of Participants with a Change in Urine Glucose
Number of Participants With a Change in Urine Ketones
Time frame: From study start to end, up to 3.5 years
Number of Participants With a Change in Urine Ketones at baseline and end of study
Number of Participants With a Change in Urine Leukocytes
Time frame: From study start to end, up to 3.5 years
Number of participants with a change in urine leukocytes at baseline and end of study
Number of Participants With a Change in Urine Hemoglobin
Time frame: From study start to end, up to 3.5 years
Number of participants with a change in urine hemoglobin at baseline and end of study
Complete Red Blood Cell Count
Time frame: From study start to end, up to 3.5 years
Changes in complete red blood cell count from baseline to end of study
Haematocrit
Time frame: From study start to end, up to 3.5 years
Changes in haematocrit from baseline to end of study
Haemoglobin
Time frame: From study start to end, up to 3.5 years
Changes in haemoglobin from baseline to end of study
Complete White Blood Cell Count
Time frame: From study start to end, up to 3.5 years
Changes in complete white blood cell count from baseline to end of study
4 secondary outcomes
Measurement of Trough Total IgG Levels
Time frame: From study start to end, up to 3.5 years
Number of Participants With Serious Bacterial Infections (SBIs).
Time frame: From study start to end, up to 3.5 years
SF-36 Health Survey.
Time frame: From study start to end, up to 3.5 years
CHQ-PF50 (Child Health Questionnaire-Parent Form)
Time frame: From study start to end, up to 3.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octanorm 16.5% in people with Primary Immunodeficiency, run by Octapharma at 7 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 16 inclusion and 27 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurrence of All Treatment-emergent Adverse Events (TEAEs) (time frame: From study start to end, up to 3.5 years). The study lists 25 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 27 Oct 2020.