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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01318993




Registration number
NCT01318993
Ethics application status
Date submitted
3/03/2011
Date registered
21/03/2011
Date last updated
14/09/2017

Titles & IDs
Public title
Open-Label Extension Study of GSK1605786A
Scientific title
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease
Secondary ID [1] 0 0
2010-022384-35
Secondary ID [2] 0 0
114644
Universal Trial Number (UTN)
Trial acronym
SHIELD-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1605786A

Experimental: GSK1605786A - 500 milligrams twice daily


Treatment: Drugs: GSK1605786A
500 milligrams twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)
Timepoint [1] 0 0
Up to Week 112
Secondary outcome [1] 0 0
Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period
Timepoint [1] 0 0
Baseline (Week 0) and up to Week 112
Secondary outcome [2] 0 0
Change From Baseline (Week 0) in Heart Rate (HR) Over Period
Timepoint [2] 0 0
Baseline (week 0) and up to Week 112
Secondary outcome [3] 0 0
Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters
Timepoint [3] 0 0
Baseline (Week 0) and up to Week 112
Secondary outcome [4] 0 0
Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters
Timepoint [4] 0 0
Baseline (Week 0) and up to Week 112
Secondary outcome [5] 0 0
Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)
Timepoint [5] 0 0
Baseline (Week 0) and up to Week 112
Secondary outcome [6] 0 0
Change From Baseline (Week 0) in Total Bilirubin
Timepoint [6] 0 0
Baseline (Week 0) and up to Week 112
Secondary outcome [7] 0 0
Change From Baseline (Week 0) in Albumin
Timepoint [7] 0 0
Baseline (Week 0) and up to Week 112
Secondary outcome [8] 0 0
Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value
Timepoint [8] 0 0
Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)
Secondary outcome [9] 0 0
Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks
Timepoint [9] 0 0
Baseline (Week 0) and up to 108 weeks
Secondary outcome [10] 0 0
Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks
Timepoint [10] 0 0
Baseline (Week 0) and up to 108 weeks
Secondary outcome [11] 0 0
Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks
Timepoint [11] 0 0
Baseline (Week 0) and up to 112 weeks
Secondary outcome [12] 0 0
Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks
Timepoint [12] 0 0
Baseline (Week 0) and up to 112 weeks

Eligibility
Key inclusion criteria
* Previous participation in a GSK-sponsored study with GSK1605786A
* Written informed consent prior to any study-specific procedures
* Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
* Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
* Fixed symptomatic stenoses or strictures of small bowel or colon
* Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
* Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
* Evidence of hepatic dysfunction or viral hepatitis
* Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/10/2013
Sample size
Target
Accrual to date
Final
399
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Bankstown
Recruitment hospital [2] 0 0
GSK Investigational Site - Hersten
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Kurralta Park
Recruitment hospital [5] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [6] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [7] 0 0
GSK Investigational Site - Prahran
Recruitment hospital [8] 0 0
GSK Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
4029 - Hersten
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
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United States of America
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Arizona
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01318993