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Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products in order to improve viral safety and to remove procoagulant activity. Since the new manufacturing process will be the same for all Quin products, a clinical study with one of the Quin products is sufficient for marketing authorisation of all new Quin products. HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are considered as a surrogate indicator of efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human hepatitis B immunoglobulin | Experimental | once, i.m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a human hepatitis B immunoglobulin solution for injection for intramuscular administration | Biological | intramuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| half-life of anti-HBs antibodies | Pharmacokinetics | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| number of adverse events | Safety | 84 days |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | Germany |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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