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An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn*s Disease (CCX114644)

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn*s Disease (CCX114644) - CCX114644

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36684
Enrollment
30
Registered
2010-11-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Treatment with GSK1605786A.

Sponsors

GlaxoSmithKline
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Completion of the placebo-controlled induction study, CCX114151, without achieving clinical response or remission or completion of maintenance study CCX114157, withdrawal from maintenance study CCX114157 due to worsening of Crohn*s disease. * Safe contraception for women of childbearing potential.

Exclusion criteria

Exclusion criteria: * Breastfeeding, pregnancy. * Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for celiac disease. * Known or suspected small bowel stricture * Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period.

Design outcomes

Primary

MeasureTime frame
Adverse effects.—

Secondary

MeasureTime frame
Clinical response or remission, change in CDAI, IBDQ score, safety, quality of life, healthcare related resource utilisation.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)