SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01697501
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with
HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the
predecessor ML18253 study. The study consists of a single visit where eligible patients will
undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.
Name: Interleukin 28B testing
Description: Blood sampling for IL28B genotypingType: Other
Chronic hepatitis B patients
Primary Outcomes
Measure: Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)
Time: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
Measure: Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
Time: EoF
Secondary Outcomes
Measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
Time: EoT, as defined in the predecessor study, was at Week 48 or Week 96
Measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
Time: EoT
Measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time: EoT and EoF
Measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time: EoT and EoF
Measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time: EoT and EoF
Measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time: EoT and EoF
Purpose: Other
Single Group Assignment
There are 2 SNPs
SNPs
1 rs12979860
Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF).
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT).
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF.
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF.
2 rs8099917
Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF. null.
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT. null.
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF.
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF.
HPO Nodes
HPO:Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE hr>Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG hr>Hepatitis
Genes 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3 hr>