| Trial ID: | L0557 |
| Source ID: | EUCTR2016-004566-26-DE
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| Associated Drug: |
Cenicriviroc
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| Title: |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis - STELLARIS
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Liver fibrosis in Subjects with Nonalcoholic Steatohepatitis <br>MedDRA version: 20.0
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Nutri
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| Interventions: |
<br>Product Name: Cenicriviroc Mesylate<br>Product Code: CVC <br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: CENICRIVIROC MESYLATE<br>CAS Number: 497223-25-3<br>Current Sponsor code: CENICRIVIROC<br>Other descriptive name: TBR-652<br>Concentration
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| Outcome Measures: |
Main Objective: Primary Objective (Part 1):<br>?€?Demonstrate the superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy, by assessing the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade)<br>Primary Objective (Part 2):<br>?€?Demonstrate the superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality, as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint) ?€? (all subjects)<br>;Secondary Objective: Part 1 and 2: (1)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis (months 12 and 60, as applicable).<br>Part 1 and 2: (2)Evaluate the safety and tolerability of CVC for the treatment of liver fibrosis in adult subjects with NASH.<br>Part 2: (3)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade), (months 12 and 60, as applicable)).;Primary end point(s): (Part 1): Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver histology relative to the Screening biopsy<br>(Part 2): Time to first occurrence of any of the following adjudicated events:<br>Death (all cause), Histopathologic progression to cirrhosis, Hepatocellular carcinoma, Liver transplant, MELD score =15, Ascites , Hospitalization (as defined by a stay of = 24 hours) for onset of: variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of =2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis);Timepoint(s) of evaluation of this end point: Part 1: Month 12<br>Part 2: Duration of studySecondary end point(s): Parts 1 and 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis, relative to the Screening biopsy
<br>Part 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver biopsy relative to the Screening biopsy;Timepoint(s) of evaluation of this end point: Months 12 and 60
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| Sponsor/Collaborators: |
Tobira Therapeutics, a subsidiary of Allergan plc
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 3
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| Enrollment: |
2000
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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| Start Date: |
22/02/2017
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
9 October 2017
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| Locations: |
United States;Portugal;Taiwan;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Austria;United Kingdom;Hungary;Mexico;Canada;Mauritius;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;New Zealand
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004566-26
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