A Phase 3 interventional study of Boya IVIG in Primary Immunodeficiency Disease, sponsored by Azidus Brasil. Not yet recruiting. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment
Among 27 studies testing Immunoglobulins, Intravenous in Primary Immunodeficiency Diseases — 2 open to participants now, 4 under way, 4 of them phase 3. Immunoglobulins, Intravenous · Primary Immunodeficiency Diseases.
Among the 27 studies testing Immunoglobulins, Intravenous in Primary Immunodeficiency Diseases, this one is the 7th largest by planned enrollment of the 26 interventional ones, is the only one that started in 2026, is one of 18 in phase 3, and was the 27th registered.
211 studies on the registry are indexed under Primary Immunodeficiency Diseases; 51 are open to participants now.
This study's planned enrollment of 50 is above the median of 36 across 125 interventional studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →2 of the 27 studies testing Immunoglobulins, Intravenous in Primary Immunodeficiency Diseases are open now.
Immunoglobulins, Intravenous: first FDA approval 1944 (Baygam, Gamastan S/D), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 35 Primary Immunodeficiency Diseases studies recruiting now, 12 (34%) set no upper age limit and 10 (29%) stop at 75 or younger; 28 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2026.
Median enrollment 45 across the 26 interventional studies. Of the 23 that completed or were terminated, 14 (61%) have results posted.
24 of 27 have an industry lead sponsor. The 10 most frequent:
Azidus Brasil is the lead sponsor of 80 studies on the registry; 5 are open to participants now.
Azidus Brasil has 2 studies filed under Primary Immunodeficiency Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies testing Immunoglobulins, Intravenous in Primary Immunodeficiency Diseases that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04640142Phase 3OctapharmaStudy to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases | 2026-11 |
| NCT04944979Phase 3Kedrion S.p.A.Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10) | 2026-12 |
Among the 27 studies testing Immunoglobulins, Intravenous in Primary Immunodeficiency Diseases, from their registry updates:
The goal of this phase 3, open-label, single-group clinical trial is to assess the efficacy of Boya IVIG in maintaining the mean number of serious bacterial infections to less than one per year in participants with primary immunodeficiency (PYD) due to common variable immunodeficiency (CVID), as defined by the European Immunodeficiency Society (ESCID) / Pan American Immunodeficiency Group (PAGID), or X-linked agammaglobulinemia (XLA), as defined by molecular genetic testing (ESCID/PAGID).
The safety and pharmacokinetics (PK) of the investigational product will also be evaluated.
Participants must:
Fifty male or female participants aged 2 to 60 years, either treatment-naive or already receiving intravenous immunoglobulin replacement therapy, will be enrolled, including at least 20 participants aged 2 to 17 years. The study will also examine the pharmacokinetic (PK) profile in adult participants.
After obtaining signed informed consent or assent, screening will include reviewing immunodeficiency history in medical records, performing safety examinations, and assessing eligibility against inclusion and exclusion criteria.
Subjects who pass screening will begin a 6-visit run-in period. For participants already receiving treatment, the interval between intravenous injections should remain as prescribed before enrollment unless modified during the run-in period. During this period, participants will receive the study IVIG. For treatment-naïve participants, the dose and administration interval during the run-in will be determined by the Investigator.
After the run-in, the one-year trial will begin at V0. Study visits will be scheduled every 21 or 28 days, based on the participant's prescribed treatment plan. Each visit will have a ±3-day window around the scheduled date. At each visit, blood samples will be collected immediately before each IVIG dose to measure IgG trough levels. If a visit occurs earlier or later than the scheduled date, whether within or outside the allowed window, the timing of the next visit will be based on the actual date of the previous visit to maintain consistent planned inter-visit intervals throughout the study.
The V0 assessment will begin when participants have IgG concentrations ≥5 g/L on two consecutive infusions under the same dosing conditions. Therefore, the run-in period may include only two visits. If, among the six visits, the trough IgG concentration does not reach 5 g/L on two consecutive visits, the participant will be considered to have failed screening but may be rescreened.
To characterize the pharmacokinetic (PK) profile of the investigational product, at least 20 adult participants will undergo additional blood sampling between two consecutive study visits to measure total IgG concentrations and antigen-specific antibody levels, including anti-pneumococcal capsular polysaccharide, anti-Haemophilus influenzae, and anti-measles antibodies.
PK sampling should preferably be performed at Visit 4 (V4), provided that a stable dosing regimen has been maintained. Participants receiving IVIG on a 21-day schedule should collect seven samples at 30 minutes, 2 hours, 24 hours, 72 hours, 7 days, 14 days, and 21 days post-infusion. Participants receiving IVIG on a 28-day schedule should collect eight additional samples at 30 minutes, 2 hours, 24 hours, 72 hours, 14 days, 21 days, and 28 days post-infusion.
The PK profile should be evaluated only after at least four consecutive dosing intervals with no changes in posology, meaning both the dose and dosing interval remain unchanged, preferably at Visit 4 (V4). If any dose or interval adjustments occur between V0 and V4, PK profile sampling should be delayed until the next visit, after dosage stability is confirmed.
Participants will be contacted weekly between infusions to collect data on adverse events, concomitant medications, duration of infection treatment, and time lost from work or school due to infections during the period.
Additionally, subjects will have continued access to the investigator's team to report adverse events and to receive advice on next steps or additional medical evaluations, if necessary.
Medical evaluation, vital signs, and oximetry, adverse events, and concomitant medication will be assessed at all visits.
Safety laboratory tests (including direct Coombs and pregnancy tests) will be performed at every 4th or 5th visit.
Inclusion Criteria
Exclusion Criteria Patients who meet any of the following criteria will be disqualified from participating.
changes in safety assessments, defined as:
Blood count
Coagulation:
o PT and > 2,5 x .
Biochemistry:
Urine I:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive Boya IVIG: Dose: 200 to 800 mg/kg Schedule of administration: 21- or 28-day interval Time frame: 54 weeks (21-day interval) or 56 weeks (28-day interval)
Biological: Boya IVIG
Intervention: Biological: Boya IVIG Boya IVIG is a 5% human immunoglobulin for intravenous administration
Also known as: IVIG, BOYA
Primary Efficacy Objective
Average incidence of serious bacterial infections per participant between V0 and Vfinal.
Time frame: 54 weeks (21-day interval schedule) or 56 weeks (28-day interval schedule)
Assessment of the rate of non-serious infections within one year
The incidence of all acute infections except the serious acute bacterial infections within the 1-year follow-up (simple descriptive statistics).
Time frame: Average incidence of non-serious infections per patient between Visit 0 and Final Visit (through study completion, an average of 1 year), as documented as treatment emergent adverse events (TEAEs).
Missing time from school/work
Assessment of time lost at school/work due to infections per year
Time frame: Average number of days off from school/work per patient/year, as collected in weekly telephone contacts.
Length of hospitalization
Assessment of the length of hospital stay per year.
Time frame: Number of days of hospitalization due to infections per participant/year between V0 and Vfinal, as documented as Adverse Events.
Use of antibiotics
Assess the use of antibiotics for therapeutic purposes.
Time frame: Tabulation of all antibiotics used, separating those indicated for prophylactic and therapeutic purposes
Total IgG trough levels
To assess the total IgG serum concentration before each infusion (IgG trough levels), between Visit 4 and Final Visit (through study completion).
Time frame: 9 months
Total IgG pharmacokinetic profile
Assess total serum IgG levels at defined times, at the fifth consecutive infusion with stable dosing, regardless of the visit.
Time frame: 21 or 28 days
Total IgG primary and secondary PK parameters
Determine area under the curv (AUC), maximum concentration (Cmax), elimination constant (Kel), distribution volume, half-life of total IgG from the concentration vs time curve.
Time frame: 21 or 28 days
Pharmacokinetic profile of anti-pneumococcal capsular antipolysaccharide
Assess anti-pneumococcal capsular antipolysaccharide levels at defined times, at the fifth consecutive infusion with stable dosing, regardless of the visit.
Time frame: 21 or 28 days
Pharmacokinetic profile of anti-Haemophilus influenzae
Assess anti-Haemophilus influenzae levels at defined times, at the fifth consecutive infusion with stable dosing, regardless of the visit.
Time frame: 21 or 28 days
Pharmacokinetic profile of anti-measles
Assess anti-measles levels at defined times, at the fifth consecutive infusion with stable dosing, regardless of the visit.
Time frame: 21 or 28 days
Infusion-related adverse events
Incidence, severity, and causality of adverse events during or within 72 hours after each infusion.
Time frame: up to 72 hours after each infusion
Emergent adverse events (TEAEs.)
Incidence, severity, and causality of all treatment-emergent adverse events, except those related to the infusion.
Time frame: 12 months
Exploratory outcome
Serum levels of IgG1, IgG2, IgG3, and IgG4 before V-6 and before and 30 minutes after the end of the V4 infusion.
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No — It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 25 phase 3 interventional studies under Primary Immunodeficiency Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 41. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Immunoglobulins, Intravenous
Primary Immunodeficiency Diseases →