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Report for Clinical Trial NCT02268864

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

NCT02268864 Hepatitis C, Chronic
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis

2 Interventions

Name: Simeprevir

Description: Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.
Type: Drug
Group Labels: 1

Simeprevir + Daclatasvir

Name: Daclatasvir

Description: Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.
Type: Drug
Group Labels: 1

Simeprevir + Daclatasvir


Primary Outcomes

Description: Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification ( Measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)

Time: At 12 weeks after end of treatment

Secondary Outcomes

Description: Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was Measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)

Time: At 4 weeks after actual EOT

Description: Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was Measure: Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)

Time: At 24 weeks after actual EOT

Description: Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, =) LLOQ at EOT.

Measure: Percentage of Participants With On-treatment Failure

Time: Up to Week 24 after actual EOT

Description: Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA Measure: Number of Participants With Viral Breakthrough

Time: Up to Week 24

Description: Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA =LLOQ during the follow-up period.

Measure: Number of Participants With Viral Relapse

Time: Up to Week 24 after actual EOT

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L31M

For cirrhotic participants (METAVIR score F4) a biopsy performed at any previous time is acceptable - Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma - Participant must have a body mass index (BMI) >= 18 Kilogram per meter^2 (kg/m^2) - Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug) Exclusion Criteria: - Participant has co-infection with HCV of another genotype; a) Participant who has HCV genotype 1b has coinfection with HCV of a genotype other than genotype 1b - Chronic HCV genotype 1b-infected participant who has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening - Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy) - Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis) - Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study - Participant has coinfection with hepatitis A or hepatitis B virus (hepatitis A antibody immunoglobulin M [IgM] or hepatitis B surface antigen [HBsAg] positive at Screening) - Participant has received a solid organ transplant Inclusion Criteria: - Participant must have chronic Hepatitis C virus (HCV) genotype 1b infection confirmed at Screening - Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at Screening - Participant must have documented fibrosis stage at Screening (or between Screening and Day 1 [baseline]). --- Y93H --- --- L31M ---

For cirrhotic participants (METAVIR score F4) a biopsy performed at any previous time is acceptable - Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma - Participant must have a body mass index (BMI) >= 18 Kilogram per meter^2 (kg/m^2) - Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug) Exclusion Criteria: - Participant has co-infection with HCV of another genotype; a) Participant who has HCV genotype 1b has coinfection with HCV of a genotype other than genotype 1b - Chronic HCV genotype 1b-infected participant who has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening - Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy) - Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis) - Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study - Participant has coinfection with hepatitis A or hepatitis B virus (hepatitis A antibody immunoglobulin M [IgM] or hepatitis B surface antigen [HBsAg] positive at Screening) - Participant has received a solid organ transplant Hepatitis C, Chronic Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis This is an open-label (all people know which treatment the participants receive) study to investigate the efficacy, safety and tolerability of simeprevir and daclatasvir in chronic Hepatitis (inflammation of the liver) C virus (HCV) genotype 1b infected participants who are treatment-naive. --- Y93H --- --- L31M ---


2 Y93H

For cirrhotic participants (METAVIR score F4) a biopsy performed at any previous time is acceptable - Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma - Participant must have a body mass index (BMI) >= 18 Kilogram per meter^2 (kg/m^2) - Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug) Exclusion Criteria: - Participant has co-infection with HCV of another genotype; a) Participant who has HCV genotype 1b has coinfection with HCV of a genotype other than genotype 1b - Chronic HCV genotype 1b-infected participant who has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening - Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy) - Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis) - Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study - Participant has coinfection with hepatitis A or hepatitis B virus (hepatitis A antibody immunoglobulin M [IgM] or hepatitis B surface antigen [HBsAg] positive at Screening) - Participant has received a solid organ transplant Inclusion Criteria: - Participant must have chronic Hepatitis C virus (HCV) genotype 1b infection confirmed at Screening - Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at Screening - Participant must have documented fibrosis stage at Screening (or between Screening and Day 1 [baseline]). --- Y93H ---

For cirrhotic participants (METAVIR score F4) a biopsy performed at any previous time is acceptable - Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma - Participant must have a body mass index (BMI) >= 18 Kilogram per meter^2 (kg/m^2) - Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug) Exclusion Criteria: - Participant has co-infection with HCV of another genotype; a) Participant who has HCV genotype 1b has coinfection with HCV of a genotype other than genotype 1b - Chronic HCV genotype 1b-infected participant who has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening - Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy) - Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis) - Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study - Participant has coinfection with hepatitis A or hepatitis B virus (hepatitis A antibody immunoglobulin M [IgM] or hepatitis B surface antigen [HBsAg] positive at Screening) - Participant has received a solid organ transplant Hepatitis C, Chronic Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis This is an open-label (all people know which treatment the participants receive) study to investigate the efficacy, safety and tolerability of simeprevir and daclatasvir in chronic Hepatitis (inflammation of the liver) C virus (HCV) genotype 1b infected participants who are treatment-naive. --- Y93H ---



HPO Nodes


HPO: