A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection

Bio2RDF uri

A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection

http://bio2rdf.org/clinicaltrials:NCT01147302

Bio2RDF identifier

NCT01147302

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Bio2RDF namespace

clinicaltrials

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Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT01147302

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

brief summary [clinicaltrials_vocabulary:brief-summary]

The purpose of this res ...... diated Rejection (AMR).

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

brief title [clinicaltrials_vocabulary:brief-title]

A Pilot Study to Evaluate the ...... te Antibody-Mediated Rejection

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

clinical result [clinicaltrials_vocabulary:clinical-result]

clinical results for clinicaltrials:NCT01147302 [clinicaltrials_resource:b19659fd094846ada8451739092107c1]

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

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:bad2da00df76a68bdd546df9a0a03bd7]

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

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:286e26afea3b653c4f493443dbb35780]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:29a0831f933970ff20bfeec9e67cd64f]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:555649f0dbbb70b11bd0b8d9750052f6]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:5673ba36e020a4097df83fc9b1764729]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:61f0151ea832bf5fe5069a29e0f9e6b4]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:87e75b1175895ace1a19c1ec5a17868a]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:9d09e31fb856569ba713e68813bdaee2]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:b4e39a35c87055c8a58062b1aeee8f22]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:ccd59eb84e1782f100ac90c06d446d75]

Change From Baseline in Histopathology Endpoints 20 days after start of treatment [clinicaltrials_resource:d5951ad879d5ba58674f53b97cb09002]

completion date [clinicaltrials_vocabulary:completion-date]

2013-06-01T00:00:00Z

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

condition [clinicaltrials_vocabulary:condition]

Graft Rejection [clinicaltrials_resource:41721a258e6c2c1141c85513534b5444]

country [clinicaltrials_vocabulary:country]

United States [clinicaltrials_resource:f253efe302d32ab264a76e0ce65be769]

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:NCT01147302 [clinicaltrials_resource:2c0a2e931364b075241d1d4fa136c8fc]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2010-06-16T00:00:00Z

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

2015-06-16T00:00:00Z

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

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

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

intervention [clinicaltrials_vocabulary:intervention]

C1 Esterase Inhibitor (Human) [clinicaltrials_resource:1ac0de63e37cc7ad837d0aa2da62d6ff]

Placebo [clinicaltrials_resource:564b7b6e0469d5cf6b075689883ae84f]

intervention browse [clinicaltrials_vocabulary:intervention-browse]

Complement C1 Inhibitor Protein [clinicaltrials_resource:0a6c46f344a30ebb9b7dedb6b8c3f0b7]

Complement C1 Inactivator Proteins [clinicaltrials_resource:d9e5c26ff6e5061202b50cdcebb4b8ec]

Complement C1s [clinicaltrials_resource:e12465688a3308944f49496f1c68ebd5]

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

Yes

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

Yes

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

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2015-06-16T00:00:00Z

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

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Shire [clinicaltrials_resource:7c5185501601fefe747cf96e7bec0fee]

location [clinicaltrials_vocabulary:location]

ViroPharma Investigative Site [clinicaltrials_resource:977628d44a5cade5e0b99bd9f2a8cee4]

nct id [clinicaltrials_vocabulary:nct-id]

NCT01147302

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

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

official title [clinicaltrials_vocabulary:official-title]

A Randomized Double-Blind Plac ...... -Sensitized Kidney Transplants

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

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

0624-201

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

outcome [clinicaltrials_vocabulary:outcome]

Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR) [clinicaltrials_resource:NCT01147302/outcome/1]

overall official [clinicaltrials_vocabulary:overall-official]

Marc E Uknis, MD [clinicaltrials_resource:afc467dada5ca14377ca5f051c8394db]

overall status [clinicaltrials_vocabulary:overall-status]

Completed [clinicaltrials_resource:07ca5050e697392c9ed47e6453f1453f]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:94869383de9f255d5ae1b416396ac2e2]

participant flow [clinicaltrials_vocabulary:participant-flow]

participant flow for clinicaltrials:NCT01147302 [clinicaltrials_resource:815cba7d63ce01b52c332ae3e335d692]

phase [clinicaltrials_vocabulary:phase]

Phase 2 [clinicaltrials_resource:56e0338b27a2d68f77402c88327b3f8d]

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

2013-04-01T00:00:00Z

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

reported events [clinicaltrials_vocabulary:reported-events]

Reported events for NCT01147302 [clinicaltrials_resource:5286d7fa31824eee87c503d06df8fb15]

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

secondary id [clinicaltrials_vocabulary:secondary-id]

2012-000441-12

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source [clinicaltrials_vocabulary:source]

Shire [clinicaltrials_resource:7c5185501601fefe747cf96e7bec0fee]

start date [clinicaltrials_vocabulary:start-date]

2010-11-01T00:00:00Z

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

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT01147302 study design [clinicaltrials_resource:54b8b2a09626537cf4f966aa675decd8]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT01147302

verification date [clinicaltrials_vocabulary:verification-date]

2014-03-01T00:00:00Z

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

identifier

clinicaltrials:NCT01147302

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

title

A Pilot Study to Evaluate the ...... te Antibody-Mediated Rejection

@en