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Due to limited data available, efficacy, and PK analyses were not performed.
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Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.
The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.
The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octagam 10% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octagam 10% | Drug | 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Occurrence of Adverse Events | During infusion or within 72 hours after end of infusion |
| Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment | Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment | after 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs | during each treatment | |
| Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis) | at each treatment date (every three to four weeks) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Frenzel, Dr. | Octapharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information | Vienna | 1100 | Austria |
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Patients previously treated with commercial Octagam 5% were to be enrolled in the study on the basis of the in- and exclusion criteria defined in the study protocol. Patients were to be enrolled only after written informed consent by the patient had been obtained.
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| ID | Title | Description |
|---|---|---|
| FG000 | Octagam 10% | Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was terminated prematurely. Owing to the limited data available (only 5 patients enrolled, of whom 2 completed the study and 3 ended treatment prematurely), efficacy and PK analyses were not performed. The safety analysis did not yield any unexpected results suggestive of a change in the risk-benefit evaluation of Octagam 10%.
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| ID | Title | Description |
|---|---|---|
| BG000 | Octagam 10% | Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days) |
| 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 | Adverse Events | Occurrence of Adverse Events | Posted | Number | participants | During infusion or within 72 hours after end of infusion |
|
|
12 Months
In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.
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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 | Octagam 10% | Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgery for inguinal condyloma | Skin and subcutaneous tissue disorders | MedDRA SOC | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eppolito | Octapharma | 201-604-1155 | michael.eppolito@octapharma.com |
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| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Assessment of Viral Safety |
| Every three months |
| Pre-next-dose Levels of Serum Total IgG | before each treatment |
| Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents | before treatement 10 and 13 (of 13 or 17 treatments) and at the end |
| Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics) | 12 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment | Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | after 6 months of treatment |
|
|
| Secondary | Vital Signs | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | during each treatment |
|
|
| Secondary | Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis) | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | at each treatment date (every three to four weeks) |
|
|
| Secondary | Assessment of Viral Safety | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | Every three months |
|
|
| Secondary | Pre-next-dose Levels of Serum Total IgG | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | before each treatment |
|
|
| Secondary | Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | before treatement 10 and 13 (of 13 or 17 treatments) and at the end |
|
|
| Secondary | Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics) | Due to premature termination of the study, data were unavailable and no analysis was done. | Posted | 12 months |
|
|
| 1 |
| 5 |
| 5 |
| 5 |
| upper respirotory infection | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
|
| gastroenteritis | Gastrointestinal disorders | MedDRA SOC | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
|
| pharyngolarynngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
|
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