Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus [clinicaltrials:NCT02093221]

Bio2RDF uri

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus [clinicaltrials:NCT02093221]

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

http://bio2rdf.org/clinicaltrials:NCT02093221

Bio2RDF identifier

NCT02093221

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

Bio2RDF namespace

clinicaltrials

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

Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT02093221

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

brief summary [clinicaltrials_vocabulary:brief-summary]

This is a multicenter, ...... ma-derived alpha1-PI in T1DM.

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

brief title [clinicaltrials_vocabulary:brief-title]

Study of Human Plasma-Derived ...... Onset Type 1 Diabetes Mellitus

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

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

C-peptide Area Under the concentration-time Curve (AUC) 10 min pre-dose, immediately pre-dose, 15, 30, 60, 90, and 120 minutes post-dose [clinicaltrials_resource:08de8389b72796ab1c96cb220f2c99b0]

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

C-peptide Area Under the concentration-time Curve (AUC) 10 min pre-dose, immediately pre-dose, 15, 30, 60, 90, and 120 minutes post-dose [clinicaltrials_resource:07729e136bea5f0b1f52e21fdd7a0e7a]

C-peptide Area Under the concentration-time Curve (AUC) 10 min pre-dose, immediately pre-dose, 15, 30, 60, 90, and 120 minutes post-dose [clinicaltrials_resource:0f6cd1f4b6e47713da10eee09af7eba3]

C-peptide Area Under the concentration-time Curve (AUC) 10 min pre-dose, immediately pre-dose, 15, 30, 60, 90, and 120 minutes post-dose [clinicaltrials_resource:91129634b6e1c5b81559a0279ffe49d7]

C-peptide Area Under the concentration-time Curve (AUC) 10 min pre-dose, immediately pre-dose, 15, 30, 60, 90, and 120 minutes post-dose [clinicaltrials_resource:971957b2df7c3f858a34e6af9c4b0fe7]

C-peptide Area Under the concentration-time Curve (AUC) 10 min pre-dose, immediately pre-dose, 15, 30, 60, 90, and 120 minutes post-dose [clinicaltrials_resource:a4e99f02cd487811227940f9bad5a323]

completion date [clinicaltrials_vocabulary:completion-date]

2017-05-01T00:00:00Z

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

condition [clinicaltrials_vocabulary:condition]

Type 1 Diabetes Mellitus [clinicaltrials_resource:b31a062745e0dde53632426b9e7c69cc]

condition browse [clinicaltrials_vocabulary:condition-browse]

Alpha 1-Antitrypsin Deficiency [clinicaltrials_resource:1dad773bb92a0e7aad8481c5f73b4e0e]

Diabetes Mellitus, Type 1 [clinicaltrials_resource:206def59d690d8aa1ae6d3886db270e7]

Diabetes Mellitus [clinicaltrials_resource:983bb7b6ac407fc1d66c1b3bd7742c83]

condition mesh [clinicaltrials_vocabulary:condition-mesh]

Alpha 1-Antitrypsin Deficiency [clinicaltrials_resource:1dad773bb92a0e7aad8481c5f73b4e0e]

Diabetes Mellitus, Type 1 [clinicaltrials_resource:206def59d690d8aa1ae6d3886db270e7]

Diabetes Mellitus [clinicaltrials_resource:983bb7b6ac407fc1d66c1b3bd7742c83]

country [clinicaltrials_vocabulary:country]

United States [clinicaltrials_resource:f253efe302d32ab264a76e0ce65be769]

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

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

eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT02093221 [clinicaltrials_resource:f4eafe06cf91ff2a1a4ee5e995dfabe6]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2014-03-11T00:00:00Z

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]

180 mg/kg Alpha1-PI [clinicaltrials_resource:9007bb08b7761d32bf588638df94f36c]

90 mg/kg Alpha1-PI [clinicaltrials_resource:c47c718497331cb578099dc94faacc0a]

Placebo [clinicaltrials_resource:f6640fe4f1cd201871a7f8a07fba48c7]

intervention browse [clinicaltrials_vocabulary:intervention-browse]

Alpha 1-Antitrypsin [clinicaltrials_resource:7e461f0d9a5188522ac5abf56304a5c7]

Protein C Inhibitor [clinicaltrials_resource:aa0462beff41049e44a2dab6b7cf2caa]

Protease Inhibitors [clinicaltrials_resource:bd458628804b4d5762575e9ef3be9215]

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

keyword [clinicaltrials_vocabulary:keyword]

Alpha1-Antitrypsin

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

Alpha1-Proteinase Inhibitor

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

Beta Cell

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

Type 1 Diabetes Mellitus

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

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2015-02-20T00:00:00Z

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

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Grifols Therapeutics Inc. [clinicaltrials_resource:40767256f373dc48ac9b01883137c3ee]

location [clinicaltrials_vocabulary:location]

University of Arizona [clinicaltrials_resource:b8c6b822d6f4550965f216bce4984f5f]

nct id [clinicaltrials_vocabulary:nct-id]

NCT02093221

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

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

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

official title [clinicaltrials_vocabulary:official-title]

A Multicenter, Randomized, Par ...... Onset Type 1 Diabetes Mellitus

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

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

GTI1302

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

overall contact [clinicaltrials_vocabulary:overall-contact]

Ed Corsi [clinicaltrials_resource:933935edffbd655f80fa9545590a06d2]

overall status [clinicaltrials_vocabulary:overall-status]

Recruiting [clinicaltrials_resource:5231dee7156b84b0d1854de1a18dd169]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:be4cea82cb21bbda79c939a4d720315b]

phase [clinicaltrials_vocabulary:phase]

Phase 2 [clinicaltrials_resource:56e0338b27a2d68f77402c88327b3f8d]

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

2016-05-01T00:00:00Z

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

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

source [clinicaltrials_vocabulary:source]

Grifols Therapeutics Inc. [clinicaltrials_resource:40767256f373dc48ac9b01883137c3ee]

start date [clinicaltrials_vocabulary:start-date]

2014-03-01T00:00:00Z

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

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT02093221 study design [clinicaltrials_resource:8b205386b013dddb3b593cc602658ec4]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT02093221

verification date [clinicaltrials_vocabulary:verification-date]

2015-02-01T00:00:00Z

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

identifier

clinicaltrials:NCT02093221

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

title

Study of Human Plasma-Derived ...... Onset Type 1 Diabetes Mellitus

@en

inDataset

clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3

type

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

label

Study of Human Plasma-Derived ...... s [clinicaltrials:NCT02093221]

@en