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| Name | Class |
|---|---|
| Grifols Therapeutics LLC | INDUSTRY |
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The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.
Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First IVIG, then Placebo | Experimental | Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. |
|
| First Placebo, then IVIG | Experimental | Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinically Diagnosed Bacterial Infections During the Treatment Period | The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted. | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinically Diagnosed Viral Infections | This is to measure the effect of IVIG on viral infections. | 3 month |
| Number of Hospital Admissions | This is to measure the effect of IVIG on hospitalizations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selim M Arcasoy, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital Lung Transplant Program | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25090414 | Result | Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014. |
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Eleven subjects were eligible and randomized, and 10 completed all study assessments. One subject discontinued the interventions because of inability to comply with the schedule of study visits. 10 subjects are needed to detect a reduction in the mean number of bacterial infections/patient by one standard deviation over three months with 80% power.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Placebo Then IVIG | Study participants consented to receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of IVIG over 12 weeks (period 2). Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks) Analysis: modified intention-to-treat |
| FG001 | Group: 2 IVIG Then Placebo | Study participants consented to receive three doses of IVIG given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of placebo over 12 weeks (period 2). Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks) Analysis: modified intention-to-treat |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Study participants consented to receive three doses of IVIG (or 0.1% albumin solution (placebo)) given four weeks apart followed by a twelve-week washout and then three doses of placebo (or IVIG). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Clinically Diagnosed Bacterial Infections During the Treatment Period | The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted. | The crossover design, in which each subject serves as his or her own control, allows sufficient power for the detection of a clinically significant effect of IVIG with only a small number of patients. A sample size of 10 patients in a crossover trial has more power to detect differences than double the sample size using a parallel design. | Posted | Number | Infections | 3 month |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Receiving IVIG During Period 1 or Period 2 | Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Selim Arcasoy, MD | Columbia University Medical Cetner | 212-305-7771 | sa2059@columbia.edu |
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| ID | Term |
|---|---|
| D000361 | Agammaglobulinemia |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Placebo | Other | 0.1% Albumin in an equal volume to the investigational product |
|
| 3 month |
| Number of Antibiotic Initiation | This is to measure the effect of IVIG on the use of antibiotics. | 3 month |
| Number of Clinically Diagnosed Fungal Infection | This is to measure the effect of IVIG on fungal infections. | 3 months |
| Number of Lymphocytic Bronchiolitis | This is to measure the effect of IVIG on lung function. | 3 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Participants Receiving Placebo During Period 1 or Period 2 | Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout). |
|
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| Secondary | Number of Clinically Diagnosed Viral Infections | This is to measure the effect of IVIG on viral infections. | Posted | Number | Number of Infections | 3 month |
|
|
|
| Secondary | Number of Hospital Admissions | This is to measure the effect of IVIG on hospitalizations. | Posted | Number | Admissions | 3 month |
|
|
|
| Secondary | Number of Antibiotic Initiation | This is to measure the effect of IVIG on the use of antibiotics. | Posted | Number | Uses of antibiotics | 3 month |
|
|
|
| Secondary | Number of Clinically Diagnosed Fungal Infection | This is to measure the effect of IVIG on fungal infections. | Posted | Number | Infections | 3 months |
|
|
|
| Secondary | Number of Lymphocytic Bronchiolitis | This is to measure the effect of IVIG on lung function. | Posted | Number | Instances of bronchiolitis | 3 months |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| 7 |
| 10 |
| EG001 | Participants Receiving Placebo During Period 1 or Period 2 | Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout). | 0 | 10 | 1 | 10 | 6 | 10 |
| Vitreous hemorrhage | Eye disorders | Non-systematic Assessment |
|
| E. coli pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospital admission for thymoglobulin infusion | Surgical and medical procedures | Non-systematic Assessment |
|
| Night sweats | General disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pedal edema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Stiff neck | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D008206 | Lymphatic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |