Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects

Bio2RDF identifier

NCT00546871

http://www.w3.org/2001/XMLSchema#string

Bio2RDF namespace

clinicaltrials

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Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT00546871

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identifiers.org URI

NCT00546871

actual enrollment [clinicaltrials_vocabulary:actual-enrollment]

49

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authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:d942c8692d257084abf3ac87279faff6

baseline [clinicaltrials_vocabulary:baseline]

baseline for NCT00546871 [clinicaltrials_resource:NCT00546871/baseline]

brief summary [clinicaltrials_vocabulary:brief-summary]

The purpose of this stu ...... nodeficiency (PID) disorders.

http://www.w3.org/2001/XMLSchema#string

brief title [clinicaltrials_vocabulary:brief-title]

Comparison of Intravenous and ...... mmunodeficiency (PID) Subjects

http://www.w3.org/2001/XMLSchema#string

clinical result [clinicaltrials_vocabulary:clinical-result]

clinical results for clinicaltrials:NCT00546871 [clinicaltrials_resource:b5ca8d14e5bf11035e497e1f9820559e]

clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:5dd192c78739096076c5d78e1029f1ef]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:64fb0e9799c2969bd7d6794a10180f3d]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:82eb0713d06c5d044191f5d68e101bdb]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:8326ebfa7626ef872d9bf3fa821b5614]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:9b6714323a6579d598e63f1aa02cfb3e]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:c640641732700dd1dac6261757573c48]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:ced8b4163728f049427afaf0c67a57c8]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:f10a06909749816dad40c8c6dc85d5f6]

clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:01e4fd6aa614f891197f29871ad183ff]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:06d161e6cbc4eee6b79b9fb48a64a6d6]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:07e7e3b26dc03f2df6c94450e6d2c555]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:109487f799d8f76171a1fed9c1126f7e]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:13560fea56b7bf083aa44ad1b2b921eb]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:1cbf5049d652a68f6ca54aff321c3520]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:30253b9e0d53dcf9520c4d60bb8d6889]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:37f351d8054b30e4dfb337d1f139b020]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:3df27d043498807fd63a4974585d5341]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage Week 12 (IV) and week 32 or 33 (SC) [clinicaltrials_resource:43a430da782adfda4ed711e6062a2e62]

completion date [clinicaltrials_vocabulary:completion-date]

2009-09-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

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eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT00546871 [clinicaltrials_resource:a9dff490cda2145432491ebbdcfb68f8]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2007-10-18T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

firstreceived results date [clinicaltrials_vocabulary:firstreceived-results-date]

2011-11-15T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

has expanded access [clinicaltrials_vocabulary:has-expanded-access]

No

http://www.w3.org/2001/XMLSchema#string

intervention [clinicaltrials_vocabulary:intervention]

Immune Globulin Intravenous (Human), 10% [clinicaltrials_resource:4304e3f1fa79d9c682389240a43ebb8f]

intervention browse [clinicaltrials_vocabulary:intervention-browse]

Immunoglobulins [clinicaltrials_resource:0500f0878274529629f2a912a5d91f88]

Rho(D) Immune Globulin [clinicaltrials_resource:8a1a5f343d201b7bef7ad0d1622d5882]

Immunoglobulins, Intravenous [clinicaltrials_resource:aa6a036fc8bcb4dd799da9e2890471f8]

Antibodies [clinicaltrials_resource:f0fcd498b473a1694055ba911752dd43]

is fda regulated [clinicaltrials_vocabulary:is-fda-regulated]

Yes

http://www.w3.org/2001/XMLSchema#string

is section 801 [clinicaltrials_vocabulary:is-section-801]

Yes

http://www.w3.org/2001/XMLSchema#string

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2015-06-26T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Baxalta US Inc. [clinicaltrials_resource:5716b9aa6b652d93955eca87736328fd]

location [clinicaltrials_vocabulary:location]

[clinicaltrials_resource:e9df592f3b727e6540b0aa7648172476]

nct id [clinicaltrials_vocabulary:nct-id]

NCT00546871

http://www.w3.org/2001/XMLSchema#string

number of arms [clinicaltrials_vocabulary:number-of-arms]

1

http://www.w3.org/2001/XMLSchema#integer

official title [clinicaltrials_vocabulary:official-title]

Tolerability and Pharmacokinet ...... mary Immunodeficiency Diseases

http://www.w3.org/2001/XMLSchema#string

org study id [clinicaltrials_vocabulary:org-study-id]

160,601

http://www.w3.org/2001/XMLSchema#integer

outcome [clinicaltrials_vocabulary:outcome]

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage [clinicaltrials_resource:NCT00546871/outcome/1]

overall official [clinicaltrials_vocabulary:overall-official]

Baxter BioScience Investigator [clinicaltrials_resource:3dcfc03ec440f1426d768b0e8e629e16]

overall status [clinicaltrials_vocabulary:overall-status]

Completed [clinicaltrials_resource:07ca5050e697392c9ed47e6453f1453f]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:965595316c5ae1a4521a298d475eb908]

participant flow [clinicaltrials_vocabulary:participant-flow]

participant flow for clinicaltrials:NCT00546871 [clinicaltrials_resource:bde84c8d8d65eaf9f0fa83d8015137b9]

phase [clinicaltrials_vocabulary:phase]

Phase 2/Phase 3 [clinicaltrials_resource:d4235ce98efbb8b69dded131ccb7fa52]

primary completion date [clinicaltrials_vocabulary:primary-completion-date]

2009-07-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

reference [clinicaltrials_vocabulary:reference]

9440877 [pubmed:9440877]

reported events [clinicaltrials_vocabulary:reported-events]

Reported events for NCT00546871 [clinicaltrials_resource:649c4eaa15fa422a69283e934d4a0230]

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

source [clinicaltrials_vocabulary:source]

Baxalta US Inc. [clinicaltrials_resource:5716b9aa6b652d93955eca87736328fd]

start date [clinicaltrials_vocabulary:start-date]

2007-10-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT00546871 study design [clinicaltrials_resource:9049054f2cef72e352baff329e17058d]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT00546871

verification date [clinicaltrials_vocabulary:verification-date]

2015-04-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

identifier

clinicaltrials:NCT00546871

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