| Trial ID: | L0556 |
| Source ID: | EUCTR2016-000499-83-NL
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| Associated Drug: |
BI 1467335
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| Title: |
A multi-centre, double-blind, parallel-group, randomised, placebo controlled phase II a study to investigate safety, tolerability, pharmacodynamics, and harmacokinetics of different doses of orally administered BI 1467335 during a 12-week treatment perio
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
Has Results
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| Results: |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000499-83/results
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| Conditions: |
Non-alcoholic steatohepatitis <br>MedDRA version: 20.0
Level: PT
Classification code 10076331
Term: Steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
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| Interventions: |
<br>Product Name: BI 1467335<br>Product Code: BI 1467335<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: not yet Assigned<br>Current Sponsor code: BI 1467335<br>Other descriptive name: BI1467335<br>Concentration unit: mg milligram(s)<br
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| Outcome Measures: |
Main Objective: The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. ;Secondary Objective: Effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, Gamma-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.;Primary end point(s): 1) Plasma amine oxidase copper-containing 3 (AOC3) activity relative to baseline in percent, 24 h post dose, after 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: 1) 24 hours <br> Secondary end point(s): 1) Percentage of subjects with adverse reactions.
<br>2) relative ALT change from baseline
<br>3) relative AST change from baseline
<br>4) relative AP change from baseline
<br>5) relative Gamma-GT change from baseline
<br>6) relative caspase cleaved cytokeratin 18 (M30) change from baseline
<br>7) relative total cytokeratin 18 (M65) change from baseline;Timepoint(s) of evaluation of this end point: 1) 16 weeks
<br>2) 12 weeks
<br>3) 12 weeks
<br>4) 12 weeks
<br>5) 12 weeks
<br>6) 12 weeks
<br>7) 12 weeks
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| Sponsor/Collaborators: |
Boehringer Ingelheim bv
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| Gender: |
All
|
| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
108
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of trea
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| Start Date: |
06/03/2017
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| Completion Date: |
14/06/2019
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| Results First Posted: |
24/06/2020
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| Last Update Posted: |
3 November 2020
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| Locations: |
France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000499-83
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