Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin [clinicaltrials:NCT01795911]

Bio2RDF identifier

NCT01795911

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

Bio2RDF namespace

clinicaltrials

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

Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT01795911

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

identifiers.org URI

NCT01795911

acronym [clinicaltrials_vocabulary:acronym]

D-LITE

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

actual enrollment [clinicaltrials_vocabulary:actual-enrollment]

165

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

arm group [clinicaltrials_vocabulary:arm-group]

NCT01795911 arm group b4876bbe9471dc74579e65e9653a099c [clinicaltrials_resource:NCT01795911/arm-group/b4876bbe9471dc74579e65e9653a099c]

authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:d942c8692d257084abf3ac87279faff6

brief summary [clinicaltrials_vocabulary:brief-summary]

Substudy C: The purpose ...... type 1b chronic HCV infection

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

brief title [clinicaltrials_vocabulary:brief-title]

Safety Study of Pegylated Inte ...... ntiviral Agents With Ribavirin

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

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

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:fa2e9c2c7789777af3f67b0fcbe3eefc]

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

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:0c0c91f53b8ed7d2bccc300e1c119b3c]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:3107f7d7cfe40e0f25e11f4cd9852392]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:3c7c5dc5d328d56104a34f1f03283a16]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:424e5eedb11ad17e76dc6cb5ae668467]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:53cea4869d98130a8b5c3cfb19fe6c38]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:6395fafe7bd4b5bf37f6c009810099a2]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:73f193567b7a8ad25bc4a594d61c4c8c]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:82c4e74213505532233206502255a0dc]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:8fdb86466484d905737aca184256e382]

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected Post-treatment Week 12 [clinicaltrials_resource:ac45db630651905ed06d226556e3c758]

completion date [clinicaltrials_vocabulary:completion-date]

2014-09-01T00:00:00Z

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

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

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

eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT01795911 [clinicaltrials_resource:03bd81bfd96356a5c367f69cbc7a6c84]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2013-02-20T00:00:00Z

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]

Pegylated Interferon Lambda [clinicaltrials_resource:2a6bdad35900bfc266e46613df053922]

Ribasphere [clinicaltrials_resource:62966384b219ad2442afb6e271bcd46e]

Daclatasvir [clinicaltrials_resource:ae5e7b5a929bc83ccbbff9fc7d4d7dfe]

intervention browse [clinicaltrials_vocabulary:intervention-browse]

Antiviral Agents [clinicaltrials_resource:a55c193ce38c04b78843d27f00b66c8a]

Interferons [clinicaltrials_resource:ac14a704eab186e8681cb6c21160bdb2]

Ribavirin [clinicaltrials_resource:c260972ef8fb801d491757e72eeceb79]

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]

2015-02-03T00:00:00Z

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

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Bristol-Myers Squibb [clinicaltrials_resource:d4c40cb9f02fd866ab671f3ce45dfa72]

link [clinicaltrials_vocabulary:link]

Investigator Inquiry form [clinicaltrials_resource:2314ff8da7caf18a90888ab03266185c]

FDA Safety Alerts and Recalls [clinicaltrials_resource:3834a9087e4006fa123d334170af525a]

BMS Clinical Trial Information [clinicaltrials_resource:cea6adb53f1855d759c532f4a5cc7e37]

location [clinicaltrials_vocabulary:location]

Alamo Medical Research [clinicaltrials_resource:e99ca6ee3a00fe6a01dc47c49c81e57e]

nct id [clinicaltrials_vocabulary:nct-id]

NCT01795911

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]

A Phase 2B, Randomized Study t ...... ype-1 Treatment naïve Subjects

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

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

AI452-008 (Substudy Part C)

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

overall official [clinicaltrials_vocabulary:overall-official]

Bristol-Myers Squibb [clinicaltrials_resource:d3a813b7ce44062a0bf05c46ffe9add7]

overall status [clinicaltrials_vocabulary:overall-status]

Completed [clinicaltrials_resource:07ca5050e697392c9ed47e6453f1453f]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:e338793c40015fe2b404bf4606ba9760]

phase [clinicaltrials_vocabulary:phase]

Phase 2 [clinicaltrials_resource:56e0338b27a2d68f77402c88327b3f8d]

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

2014-04-01T00:00:00Z

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

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

secondary id [clinicaltrials_vocabulary:secondary-id]

2010-022568-11

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

source [clinicaltrials_vocabulary:source]

Bristol-Myers Squibb [clinicaltrials_resource:d4c40cb9f02fd866ab671f3ce45dfa72]

start date [clinicaltrials_vocabulary:start-date]

2013-03-01T00:00:00Z

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

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT01795911 study design [clinicaltrials_resource:324293cc9a0f3fccb53f06a43add785e]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT01795911

verification date [clinicaltrials_vocabulary:verification-date]

2015-02-01T00:00:00Z

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

identifier

clinicaltrials:NCT01795911

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

title

Safety Study of Pegylated Inte ...... ntiviral Agents With Ribavirin

@en

inDataset

clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3

type

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]