| Trial ID: | L0531 |
| Source ID: | EUCTR2012-002564-27-GB
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| Associated Drug: |
Testosterone Undecanoate
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| Title: |
Pilot open study of testosterone replacement in non-alcoholic steatohepatitis - TEREPINS: Testosterone Replacement in Non-alcoholic Steatohepatitis
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non alcoholic fatty liver disease (NAFLD) in men with low serum testosterone levels;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
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| Interventions: |
<br> Trade Name: Nebido<br> Product Name: Testosterone Undecanoate (Nebido)<br> Product Code: not applicable<br> Pharmaceutical Form: Injection<br> INN or Proposed INN: Testosteron
|
| Outcome Measures: |
Main Objective: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months, improve severity of steatosis assessed by liver biopsy?;<br> Secondary Objective: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months,<br><br> - improve severity of associated steatohepatitis on liver biopsy?<br> - reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)?<br><br> The work proposed here is an open pilot study of 10 patients, the main aim of which is to assess the effect size of TRT in regard to these end points (regarding which there are no published data), thereby allowing power calculations for a more definitive phase II trial. Other aims would be assessing recruitment and consent rates, which would also inform the design of the larger study.<br> ;<br> Primary end point(s): Improvement in severity of steatosis on repeat liver biopsy after 52 weeks.<br> ;Timepoint(s) of evaluation of this end point: This will he assessed by grading fat infiltration on repeat liver biopsy after 52 weeks of treatment with testosterone replacement therapy, which will be compared to baseline liver biopsy (performed for clinical diagnosis). <br> Secondary end point(s): 1. Proportion of patients in whom liver inflammation, ballooning and fibrosis respectively improve<br> 2. Change in fat content of liver by MR spectroscopy and its correlation with steatosis on liver biopsy<br> 3. Change in HOMA index<br> 4. Change in serum liver enzymes<br> 5. Adverse events<br><br> (B) Eligibility, recruitment and data completeness rates<br> ;Timepoint(s) of evaluation of this end point: 12 months as per primary endpoint described above.
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| Sponsor/Collaborators: |
Sheffield Teaching Hospitals NHS Foundation Trust
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| Gender: |
Male
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
10
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
<br> Controlled: no<br> Randomised: no<br> Open: no<br> Single blind: no<br> Double blind: no<br> Parallel group: no<br> Cross over: no<br>
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| Start Date: |
04/01/2013
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
30 April 2019
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| Locations: |
United Kingdom
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002564-27
|
