A Phase 3 interventional study of Immune Globulin Intravenous and Prometic's Immune Globulin Intravenous 10% in Primary Immunodeficiency, sponsored by Prometic Biotherapeutics, Inc.. Completed at 13 sites in United States. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Prometic Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
This is a pivotal Phase 3, open-label, single-arm, multicenter study to assess the tolerability, safety, efficacy, and Pharmacokinetics of the Investigational Medicinal Product in adults and children with Primary Immunodeficiency Diseases (PIDD). A total of approximately 75 subjects aged 2-80 years will be enrolled in the study. Subjects who switch from an investigational immune globulin or subcutaneous immune globulin (IGSC) are required to receive a stable dose of commercial product (CP), which is a licensed commercially available immune globulin intravenous (IGIV) product for at least 3 cycles before they can be given the Investigational Medicinal Product . This study schema will result in the Commercial Product Treatment Period and Investigational Medicinal Product Treatment Period. All subjects will be treated on an outpatient basis with the Investigational Medicinal Product for approximately 1 year, with the dose and schedule based on their previous IGIV treatment regimen (21-day or 28-day dosing interval). A subset of subjects will participate in a Pharmacokinetics sub-study.
The primary objective of the study is to examine the rate of clinically documented serious bacterial infections (SBIs) in subjects treated with the Investigational Medicinal Product to achieve a rate of less than one SBI per year.
211 studies on the registry are indexed under Primary Immunodeficiency Diseases; 51 are open to participants now.
This study's enrollment of 82 is above the median of 36 across 125 interventional studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →Prometic Biotherapeutics, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The subject must have one of the following three diagnoses (isolated PIDD of other types will be excluded):
Exclusion Criteria:
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.
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.
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 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.
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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 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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who enroll in the study while on Gammargard, Gammaplex, Gamunex, or Octogam IGIV Product and need to wait for the scheduled start of Prometic IGIV (10%) treatment will continue on their usual dose and treatment cycle with Gammargard, Gammaplex, Gamunex, or Octogam IVIG Product during this period.
Biological: Immune Globulin Intravenous
Subjects will receive Prometic Immune Globulin Intravenous 10%
Biological: Prometic's Immune Globulin Intravenous 10%
Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product
Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG)
Annual Rate of Occurrence of Serious Bacterial Infections (SBI)
SBIs were calculated for each subject as 52n/w, where n is the number of reported SBIs and w is the number of weeks on study. For the combined cohorts only, a 99% one-sided (upper) confidence limit for the incidence rate of SBIs (scaled to represent 12 months exposure if necessary) was derived, and the objective of demonstrating that the true infection rate was below 1 per subject per year was considered established if this upper limit was less than 1. To calculate the confidence limit, a negative binomial regression model will be used. This model includes an overdispersion parameter to account for possible intra-subject correlation as well as the actual time period each subject is on the study as an offset variable.
Time frame: One year
Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion
Subject's total IgG levels will be assessed prior to each Prometic IGIV 10% infusion
Time frame: One year
| Milestone | Cohort 1 - Adult | Cohort 2 - Pediatric |
|---|---|---|
| Started | 50 | 25 |
| Completed | 47 | 18 |
| Not completed | 3 | 7 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Major protocol violation | 0 | 1 |
| Withdrew: Other | 2 | 2 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Physician decision | 0 | 1 |
SBIs were calculated for each subject as 52n/w, where n is the number of reported SBIs and w is the number of weeks on study. For the combined cohorts only, a 99% one-sided (upper) confidence limit for the incidence rate of SBIs (scaled to represent 12 months exposure if necessary) was derived, and the objective of demonstrating that the true infection rate was below 1 per subject per year was considered established if this upper limit was less than 1. To calculate the confidence limit, a negative binomial regression model will be used. This model includes an overdispersion parameter to account for possible intra-subject correlation as well as the actual time period each subject is on the study as an offset variable.
| Rate of events per subject per year | CP Treatment Period | Prometic IGIV 10% Treatment Period | Prometic IGIV 10% Treatment Period (Cohort 1) | Prometic IGIV 10% Treatment Period (Cohort 2) |
|---|---|---|---|---|
| Annual Rate of Occurrence of Serious Bacterial Infections (SBI) | 0 (NA to NA) | 0.01 (NA to 0.03) | 0 (NA to NA) | 0.03 (NA to NA) |
Subject's total IgG levels will be assessed prior to each Prometic IGIV 10% infusion
| mg/dL | CP Treatment Period | Prometic IGIV 10% Treatment Period | Prometic IGIV 10% Treatment Period (Cohort 1) | Prometic IGIV 10% Treatment Period (Cohort 2) |
|---|---|---|---|---|
| Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion | 1075.131 ± 210.7547 | 1043.401 ± 208.3044 | 1070.725 ± 219.3308 | 988.752 ± 175.7991 |
Collected over Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CP Treatment Period | 0/66 (0%) | 5/66 (7.6%) | 57/66 (86.4%) |
| Prometic IGIV 10% Treatment Period | 0/75 (0%) | 7/75 (9.3%) | 72/75 (96%) |
| Event | CP Treatment Period | Prometic IGIV 10% Treatment Period |
|---|---|---|
| BacteremiaInfections and infestations | 0/66 | 2/75 |
| GastroenteritisInfections and infestations | 1/66 | 0/75 |
| PneumoniaInfections and infestations | 1/66 | 0/75 |
| Knee arthroplastySurgical and medical procedures | 1/66 | 1/75 |
| Upper limb fractureInjury, poisoning and procedural complications | 1/66 | 0/75 |
| Cervical spinal stenosisMusculoskeletal and connective tissue disorders | 1/66 | 0/75 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/66 | 0/75 |
| InfluenzaInfections and infestations | 0/66 | 1/75 |
| SepsisInfections and infestations | 0/66 | 1/75 |
| False positive investigation resultInvestigations | 0/66 | 1/75 |
| Event | CP Treatment Period | Prometic IGIV 10% Treatment Period |
|---|---|---|
| HeadacheNervous system disorders | 11/66 | 24/75 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/66 | 21/75 |
| Upper respiratory tract infectionInfections and infestations | 13/66 | 18/75 |
| FatigueGeneral disorders | 3/66 | 17/75 |
| PyrexiaGeneral disorders | 3/66 | 16/75 |
| SinusitisInfections and infestations | 14/66 | 16/75 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/66 | 12/75 |
| Acute sinusitisInfections and infestations | 3/66 | 10/75 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 2/66 | 10/75 |
| DiarrhoeaGastrointestinal disorders | 1/66 | 9/75 |
| Age, Continuous(years) | Cohort 1 - Adult | Cohort 2 - Pediatric | Total |
|---|---|---|---|
| Median | 57 (17 to 75) | 9 (3 to 15) | 42.0 (3 to 75) |
| Sex: Female, Male(Participants) | Cohort 1 - Adult | Cohort 2 - Pediatric | Total |
|---|---|---|---|
| Female | 31 | 5 | 36 |
| Male | 19 | 20 | 39 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 - Adult | Cohort 2 - Pediatric | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 45 | 19 | 64 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Cohort 1 - Adult | Cohort 2 - Pediatric | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 46 | 24 | 70 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Time since first Primary Immune Deficiency Disease (PIDD) diagnosis (years)(years) | Cohort 1 - Adult | Cohort 2 - Pediatric | Total |
|---|---|---|---|
| Median | 12 (0.9 to 39.5) | 1.9 (0.3 to 14.1) | 6.4 (0.3 to 39.5) |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Nov 2021. 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.
Primary Immunodeficiency Diseases →
Prometic Biotherapeutics, Inc.