A Phase 4 interventional study of Vivaglobin in Common Variable Immunodeficiency and Agammaglobulinemia, sponsored by CSL Behring. Completed at 6 sites in 4 countries. Open to participants aged 1 Year to 70 Years. Per ClinicalTrials.gov, last updated 2013-06-20.
Sponsored by CSL Behring (part of CSL Limited) · Phase 4, Interventional, and Treatment
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.
54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 39 interventional studies indexed under Common Variable Immunodeficiency.
Browse Common Variable Immunodeficiency studies →CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key 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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
Drug: Vivaglobin
Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.
Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12
Time frame: On Day 12
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19
Time frame: On Day 19
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26
Time frame: On Day 26
IgG Increase (Change From Baseline) on Day 12
Time frame: Baseline to Day 12
Overall Rate of Infections
Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations".
Time frame: For the duration of the study, up to approximately 25 weeks
Total Serum IgG Trough Levels on Day 12
Time frame: On Day 12
Total Serum IgG Trough Levels at Week 25
Time frame: At Week 25
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12
Time frame: On Day 12
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25
Time frame: At Week 25
Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12
Time frame: On Day 12
Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25
Time frame: At Week 25
Use of Antibiotics for Infection Prophylaxis and Treatment
Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.
Time frame: For the duration of the study, up to approximately 25 weeks
Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)
The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.
Time frame: At study completion, approximately Week 25
Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)
The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.
Time frame: At study completion, approximately Week 25
Number of Patients With Adverse Events (AEs) by Severity and Relatedness
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Rate of AEs by Severity and Relatedness
The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Number of Patients With Local Reactions by Severity and Relatedness
Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Rate of Local Reactions by Severity and Relatedness
The rate was the number of local reactions over the number of infusions administered. Local reactions included: * infusion site: erythema, pain, pruritus, rash, reaction, swelling; * injection site: bruising, erythema, irritation, pruritus, swelling; * edema peripheral; * tenderness; * erythema; * pruritus; and * skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters
Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).
Time frame: At Weeks 12 and 25
Number of Patients With Clinically Relevant Changes in Vital Signs
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Time frame: At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)
| Milestone | Vivaglobin |
|---|---|
| Started | 18 |
| Completed | 17 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| proportion of participants | Vivaglobin |
|---|---|
| Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19 | 0.944 (0.7271 to 0.9986) |
| proportion of participants | Vivaglobin |
|---|---|
| Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26 | 1.000 (0.8147 to 1.0000) |
| g/L | Vivaglobin |
|---|---|
| IgG Increase (Change From Baseline) on Day 12 | 3.941 ± 0.7466 |
Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations".
| infections per patient year | Vivaglobin |
|---|---|
| Overall Rate of Infections | 2.785 (1.785 to 4.144) |
| g/L | Vivaglobin |
|---|---|
| Total Serum IgG Trough Levels on Day 12 | 7.466 ± 1.4592 |
| g/L | Vivaglobin |
|---|---|
| Total Serum IgG Trough Levels at Week 25 | 8.039 ± 1.1793 |
| IU/mL | Vivaglobin |
|---|---|
| Cytomegalovirus | 3.182 ± 0.8025 |
| Tetanus | 1.399 ± 0.3846 |
| Measles | 0.743 ± 0.3681 |
| proportion of patients | Vivaglobin |
|---|---|
| Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 | 0.944 (0.7271 to 0.9986) |
| IU/mL | Vivaglobin |
|---|---|
| Cytomegalovirus | 3.638 ± 2.2649 |
| Tetanus | 1.623 ± 0.9344 |
| Measles | 0.879 ± 0.8993 |
| mg/L | Vivaglobin |
|---|---|
| H. influenzae | 1.023 ± 0.3141 |
| S. pneumoniae | 18.588 ± 9.4659 |
| mg/L | Vivaglobin |
|---|---|
| H. influenzae | 1.671 ± 0.7796 |
| S. pneumoniae | 26.985 ± 22.2594 |
Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.
| participants | Vivaglobin |
|---|---|
| Prophylaxis | 1 |
| Treatment | 8 |
The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.
| units on a scale | Vivaglobin |
|---|---|
| Physical functioning | 75.50 ± 33.948 |
| Role-physical | 70.63 ± 37.038 |
| Bodily pain | 65.60 ± 37.262 |
| General health | 56.40 ± 27.097 |
| Vitality | 54.40 ± 28.575 |
| Social functioning | 80.00 ± 30.162 |
| Role-emotional | 79.17 ± 33.158 |
| Mental health | 74.50 ± 23.268 |
The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.
| units on a scale | Vivaglobin |
|---|---|
| Global health | 82.50 ± 15.353 |
| Physical functioning | 97.91 ± 4.135 |
| Role/social limitations - emotional/behavioral | 100.00 ± 0.000 |
| Role/social limitations - physical | 95.84 ± 11.773 |
| Bodily pain | 82.50 ± 24.349 |
| Behavior | 74.06 ± 13.899 |
| Global behavior | 75.63 ± 12.939 |
| Mental health | 83.13 ± 13.871 |
| Self esteem | 90.64 ± 6.948 |
| General health perceptions | 61.66 ± 22.791 |
| Change in health | 84.38 ± 18.601 |
| Parental impact - emotional | 64.58 ± 39.530 |
| Parental impact - time | 88.90 ± 15.698 |
| Family activities | 86.98 ± 17.457 |
| Family cohesion | 77.50 ± 15.353 |
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
| participants | Vivaglobin |
|---|---|
| Total AEs | 14 |
| Mild AEs | 14 |
| Moderate AEs | 5 |
| Severe AEs | 2 |
| Not related AEs | 14 |
| Possibly related AEs | 3 |
| Probably related AEs | 4 |
| Related AEs | 5 |
The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
| AEs per infusion | Vivaglobin |
|---|---|
| Total AEs | 0.305 |
| Mild AEs | 0.263 |
| Moderate AEs | 0.034 |
| Severe AEs | 0.007 |
| Not related AEs | 0.200 |
| Possibly related AEs | 0.013 |
| Probably related AEs | 0.018 |
| Related AEs | 0.074 |
Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
| participants | Vivaglobin |
|---|---|
| Total local reactions | 6 |
| Mild local reactions | 6 |
| Moderate local reactions | 0 |
| Severe local reactions | 0 |
| Not related local reactions | 1 |
| Possibly related local reactions | 0 |
| Probably related local reactions | 1 |
| Related local reactions | 5 |
The rate was the number of local reactions over the number of infusions administered. Local reactions included: * infusion site: erythema, pain, pruritus, rash, reaction, swelling; * injection site: bruising, erythema, irritation, pruritus, swelling; * edema peripheral; * tenderness; * erythema; * pruritus; and * skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
| local reactions per infusion | Vivaglobin |
|---|---|
| Total local reactions | 0.076 |
| Mild local reactions | 0.076 |
| Moderate local reactions | 0.000 |
| Severe local reactions | 0.000 |
| Not related local reactions | 0.004 |
| Possibly related local reactions | 0.000 |
| Probably related local reactions | 0.009 |
| Related local reactions | 0.064 |
Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).
| participants | Vivaglobin |
|---|---|
| Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters | 0 |
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
| participants | Vivaglobin |
|---|---|
| Number of Patients With Clinically Relevant Changes in Vital Signs | 0 |
Collected over For the duration of the study, up to approximately 25 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivaglobin | — | 2/18 (11.1%) | 14/18 (77.8%) |
| Event | Vivaglobin |
|---|---|
| HeadacheNervous system disorders | 1/18 |
| MeningitisInfections and infestations | 1/18 |
| PyrexiaGeneral disorders | 1/18 |
| VomitingGastrointestinal disorders | 1/18 |
| Pseudomonal bacteraemiaInfections and infestations | 1/18 |
| Haemophilus infectionInfections and infestations | 1/18 |
| Pseudomonas bronchitisInfections and infestations | 1/18 |
| Event | Vivaglobin |
|---|---|
| PyrexiaGeneral disorders | 5/18 |
| HeadacheNervous system disorders | 5/18 |
| NauseaGastrointestinal disorders | 4/18 |
| Injection site swellingGeneral disorders | 4/18 |
| AstheniaGeneral disorders | 3/18 |
| Injection site erythemaGeneral disorders | 3/18 |
| Upper respiratory tract infectionInfections and infestations | 3/18 |
| VomitingGastrointestinal disorders | 2/18 |
| FatigueGeneral disorders | 2/18 |
| Infusion site erythemaGeneral disorders | 2/18 |
| Age Continuous(years) | Vivaglobin |
|---|---|
| Mean | 25.9 ± 21.85 |
| Age, Customized(participants) | Vivaglobin |
|---|---|
| 2 to < 12 years | 6 |
| ≥ 12 to ≤ 16 years | 2 |
| > 16 to < 65 years | 8 |
| ≥ 65 years | 2 |
| Sex: Female, Male(Participants) | Vivaglobin |
|---|---|
| Female | 8 |
| Male | 10 |
The record gives a start of Mar 2007, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.
Results were first posted in May 2013, 4 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Common Variable Immunodeficiency →