A Phase 3 interventional study of Gammaplex (5%) and Gammaplex 10 in Primary Immune Deficiency Disorders, Common Variable Immunodeficiency and X-linked Agammaglobulinaemia, sponsored by Bio Products Laboratory. Completed at 17 sites in 3 countries. Open to participants aged 2 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Bio Products Laboratory · Phase 3, Interventional, and Treatment
The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects.
The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.
211 studies on the registry are indexed under Primary Immunodeficiency Diseases; 51 are open to participants now.
This study's enrollment of 48 is above the median of 36 across 125 interventional studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →Bio Products Laboratory is the lead sponsor of 27 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.
Adult cohort: The subject is aged 16 to 55 years inclusive, is of either sex, and belongs to any ethnic group.
Pediatric cohort: The subject is aged 2 to 15 years inclusive, is of either sex, weighs at least 10 kg, and belongs to any ethnic group.
Exclusion criteria:
The subject has positive results for any of the following at Screening:
The subject has levels > 2.5 times the , as defined at the central laboratory, of any of the following at Screening:
The subject is receiving the following medication:
The subject is known to be intolerant to any component of Gammaplex, such as sorbitol (i.e. hereditary intolerance to fructose) or glycine.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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 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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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 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).
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Biological: Gammaplex (5%) · Biological: Gammaplex 10
Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Biological: Gammaplex (5%) · Biological: Gammaplex 10
Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Biological: Gammaplex 10
Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects
Time frame: After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion
Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects
Time frame: After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion
Secondary Bioequivalence Analysis - IgG Trough Levels
Time frame: After a minimum 5 infusions on each product, at pre-infusion.
| Milestone | Treatment Sequence 1 - Adults | Treatment Sequence 2 - Adults | Pediatrics |
|---|---|---|---|
| Started | 14 | 19 | 15 |
| Completed | 14 | 18 | 14 |
| Not completed | 0 | 1 | 1 |
| ratio Gammaplex 10%/Gammaplex 5% | Gammaplex 10% | Gammaplex 5% |
|---|---|---|
| AUC(0-t) absolute | 1.01 (0.98 to 1.03) | 1.01 (0.98 to 1.03) |
| AUC(0-t) baseline-adjusted | 1.07 (0.93 to 1.23) | 1.07 (0.93 to 1.23) |
| ratio Gammaplex 10%/Gammaplex 5% | Gammaplex 10% | Gammaplex 5% |
|---|---|---|
| AUC(0-t) absolute | 0.99 (0.95 to 1.02) | 0.99 (0.95 to 1.02) |
| AUC(0-t) baseline-adjusted | 1.10 (0.96 to 1.26) | 1.10 (0.96 to 1.26) |
| ratio Gammaplex 10%/Gammaplex 5% | Gammaplex 10% | Gammaplex 5% |
|---|---|---|
| 28-day dosing interval | 0.98 (0.94 to 1.02) | 0.98 (0.94 to 1.02) |
| 21-day dosing interval | 0.95 (0.92 to 0.99) | 0.95 (0.92 to 0.99) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gammaplex 5% - All Subjects | 0/33 (0%) | 2/33 (6.1%) | 23/33 (69.7%) |
| Gammaplex 10% - All Subjects | 0/47 (0%) | 1/47 (2.1%) | 44/47 (93.6%) |
| Event | Gammaplex 5% - All Subjects | Gammaplex 10% - All Subjects |
|---|---|---|
| Neuroendocrine tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/33 | 0/47 |
| Craniocerebral injuryInjury, poisoning and procedural complications | 1/33 | 0/47 |
| IIIrd nerve paralysisNervous system disorders | 1/33 | 0/47 |
| Anaphylactic reactionImmune system disorders | 0/33 | 1/47 |
| Event | Gammaplex 5% - All Subjects | Gammaplex 10% - All Subjects |
|---|---|---|
| HeadacheNervous system disorders | 6/33 | 11/47 |
| Upper respiratory tract infectionInfections and infestations | 2/33 | 8/47 |
| Acute sinusitisInfections and infestations | 5/33 | 3/47 |
| SinusitisInfections and infestations | 1/33 | 7/47 |
| InfluenzaInfections and infestations | 0/33 | 6/47 |
| Viral upper respiratory tract infectionInfections and infestations | 4/33 | 4/47 |
| NasopharyngitisInfections and infestations | 1/33 | 5/47 |
| RashSkin and subcutaneous tissue disorders | 0/33 | 5/47 |
| BronchitisInfections and infestations | 3/33 | 0/47 |
| MigraineNervous system disorders | 3/33 | 3/47 |
| Age, Categorical(Participants) | Treatment Sequence 1 - Adults | Treatment Sequence 2 - Adults | Pediatrics | Total |
|---|---|---|---|---|
| <=18 years | 1 | 1 | 15 | 17 |
| Between 18 and 65 years | 13 | 18 | 0 | 31 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Treatment Sequence 1 - Adults | Treatment Sequence 2 - Adults | Pediatrics | Total |
|---|---|---|---|---|
| Female | 12 | 9 | 7 | 28 |
| Male | 2 | 10 | 8 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Sequence 1 - Adults | Treatment Sequence 2 - Adults | Pediatrics | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 2 | 3 |
| Not Hispanic or Latino | 14 | 18 | 13 | 45 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Sequence 1 - Adults | Treatment Sequence 2 - Adults | Pediatrics | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 14 | 19 | 15 | 48 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Sequence 1 - Adults | Treatment Sequence 2 - Adults | Pediatrics | Total |
|---|---|---|---|---|
| Hungary | 0 | 0 | 1 | 1 |
| United States | 11 | 19 | 14 | 44 |
| United Kingdom | 3 | 0 | 0 | 3 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Primary Immunodeficiency Diseases →
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