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Report for Clinical Trial NCT00470171

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis

This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis. The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group. The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.

NCT00470171 Serum Levels of ALAT Transaminases Serum Markers for Fibrosis and Hepatic Inflammation
MeSH: Fatty Liver Non-alcoholic Fatty Liver Disease Inflammation
HPO: Hepatic steatosis

1 Interventions

Name: Ursodesoxycholic acid

Type: Drug


Primary Outcomes

Measure: A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 C282Y

- Alcohol consumption of >20 g/day for women and > 30 g/day for men - Hepatitis from other causes: chronic viral hepatitis B or C, elevated ferritin levels associated with C282Y homozygosity, primary biliary cirrhosis, primary sclerosing cholangitis, well documented auto-immune hepatitis (specific autoantibodies, hypergammaglobulinemia, consistent histologic changes), alpha1 antitrypsin deficiency, Wilson's disease, HIV infection. --- C282Y ---



HPO Nodes


HPO:
Hepatic steatosis
Genes 137
ATP7B LDLRAP1 MPV17 CLPB APOE APOB SLC40A1 POLG HNF1B COA8 ABCG8 BSCL2 HFE GPD1 BCS1L CIDEC ACAD9 LYRM4 AGPAT2 LMNA LMNB2 PRDM16 CAV1 FOS LMNA TYMP LIPE RERE BCS1L MPV17 BSCL2 CIDEC MCCC1 ACADM PLIN1 SLC25A13 HADHB ETFA CAV1 XRCC4 CPT1A FBP1 PCK1 PTRH2 CEP19 RMND1 LMNA GABRD POLR3A TMEM199 NSMCE2 PPARG ADK ACAD9 LIPA TFAM NGLY1 PMM2 HNRNPA1 VPS33A AKT2 POLD1 MARS1 DDOST TRAPPC11 ETFB ACADVL BSCL2 ALMS1 LMNA LARS1 CPT2 CBS CARS2 COX15 NDUFAF1 LRPPRC ALDOB PCSK9 HNRNPA2B1 TRMU PGM1 NSMCE2 CPT2 LIPE ACOX1 LDLR CYP7A1 MRPL44 PCK2 DNAJC19 LMNA FARSB ABHD5 CAVIN1 PNPLA2 HADH ZMPSTE24 ETFDH ALMS1 PNPLA2 SLC22A5 PHKG2 AGPAT2 DGUOK ATP6AP1 COG6 ABHD5 HADHA PHKA2 SLC40A1 TARS2 LMNA TRAPPC11 PPARG MRPS7 KCNAB2 ACADL HADH SLC25A13 ACADM VCP HNF4A PLIN1 PPARG EARS2 SAR1B CAVIN1 SLC25A13 HSD17B4 DNAJC19 RRM2B SKI CYP19A1 IARS1 POLG ABCG5