WHO ICTRP trial
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the…
NL-OMON48673 · Overview of Medical Research in the Netherlands (NL-OMON)
Key facts
| Trial ID | NL-OMON48673 |
|---|---|
| Public title | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease |
| Scientific title | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease - MANTA / GS-US-418-4279 |
| Primary sponsor | Gilead Sciences |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Study type | Interventional |
| Phase | 2 |
| Countries | Australia;Austria;Canada;France;Germany;India;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation ;Sri Lanka;Switzerland;Ukraine;United Kingdom;United States of America |
| Conditions | chronic gastrointestinal inflammation Inflammatory Bowel Disease;10017969;chronic gastrointestinal inflammation;Inflammatory Bowel Disease |
| Interventions | 200 mg filgotinib tablet orally once daily or placebo ;Crohn's disease;Filgotinib;Testicular safety;Ulcerative colitis |
| Registration date | Apr 12, 2019 |
| Target size | 6 |
| Secondary IDs | 2017-000402-38;NCT03201445;NL62946.078.17 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: