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Report for Clinical Trial NCT01221298
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
NCT01221298 Hepatitis C HCV Chronic Hepatitis C Infection Hepatitis C Genotype 1 MeSH:Infection Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic
HPO:Chronic active hepatitis Chronic hepatitis Hepatitis
4 Interventions
Name: ABT-450
Name: ABT-072
Name: Ribavirin
Name: Ritonavir
Primary Outcomes
Description: Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
Measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 Time: Week 4 through Week 12Secondary Outcomes
Description: Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.
Measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) Time: Week 2Description: Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
Measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Time: Week 4Description: Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.
Measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment Time: Post-treatment Day 1 to Post-treatment Week 12Description: Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.
Measure: Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment Time: Post-treatment Day 1 to Post-treatment Week 24Description: The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA
Description: Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.
Measure: Time to Virologic Relapse Through 24 Weeks Post-treatment Time: Post-treatment Day 1 to Post-treatment Week 24Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 rs12979860
Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.. Inclusion Criteria: - Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C. - Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV. - Treatment naïve male or female between the ages of 18 and 65. - Females must be postmenopausal for at least 2 years or surgically sterile.
Inclusion Criteria: - Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C. - Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV. - Treatment naïve male or female between the ages of 18 and 65. - Females must be postmenopausal for at least 2 years or surgically sterile.