benzimidazole and Cirrhosis, Liver

benzimidazole has been researched along with Cirrhosis, Liver in 3 studies

1H-benzimidazole : The 1H-tautomer of benzimidazole.

Research

Studies (3)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)

Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. (NCT03222583)
Timeframe: 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.

Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12

SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. (NCT03222583)
Timeframe: 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen

Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12

SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug. (NCT03222583)
Timeframe: 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.

Percentage of Participants in Arm A With On-treatment Virologic Failure

"On-treatment virologic failure was defined as meeting one of the following:~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or~confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment." (NCT03222583)
Timeframe: 8 or 16 weeks depending on the treatment regimen

Percentage of Participants in Arm A With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection. (NCT03222583)
Timeframe: From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen).

Percentage of Participants With On-treatment Virologic Failure

"On-treatment virologic failure was defined as meeting one of the following:~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or~confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment." (NCT03235349)
Timeframe: 12 or 16 weeks depending on the treatment regimen

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection. (NCT03235349)
Timeframe: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. (NCT03235349)
Timeframe: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02723084)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Post-Treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. 95% CI was calculated using the Wilson score method. (NCT02723084)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02723084)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method. (NCT02723084)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for arm A), and 12 (end of treatment for arm B) or premature discontinuation from treatment

Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02707952)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02707952)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method. (NCT02707952)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

Percentage of Participants With Post-Treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method. (NCT02707952)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02707952)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02707952)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02642432)
Timeframe: Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02642432)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02642432)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value of post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02640482)
Timeframe: Up to Week 12 post baseline

Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of DB treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02640482)
Timeframe: Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02640482)
Timeframe: 12 weeks after the last actual dose of active study drug

Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis

SVR12 was defined as plasma HCV RNA level NCT02640482)
Timeframe: 12 weeks after the last actual dose of active study drug

Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure

SVR12 was defined as HCV RNA level NCT02640482)
Timeframe: 12 weeks after the last actual dose of active study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02636595)
Timeframe: Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02636595)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02636595)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02651194)
Timeframe: up to 12 weeks

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02651194)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02651194)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02738138)
Timeframe: Up to 12 weeks

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02738138)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02738138)
Timeframe: 12 weeks after last dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA NCT02604017)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants

On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA NCT02604017)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels NCT02604017)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants

Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels NCT02604017)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02604017)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With SVR12

SVR12 was defined as plasma HCV RNA level NCT02604017)
Timeframe: 12 weeks after last actual dose of study drug

Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants

SVR12 was defined as plasma HCV RNA level NCT02604017)
Timeframe: 12 weeks after last actual dose of study drug

Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants

SVR12 was defined as plasma HCV RNA level NCT02604017)
Timeframe: 12 weeks after last actual dose of study drug

Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants

SVR12 was defined as plasma HCV RNA level NCT02604017)
Timeframe: 12 weeks after last actual dose of study drug

Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later

SVR12 was defined as plasma HCV RNA level NCT02604017)
Timeframe: 12 weeks after last actual dose of study drug

Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants

SVR12 was defined as plasma HCV RNA level NCT02604017)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02640157)
Timeframe: Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02640157)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A

SVR12 was defined as plasma HCV RNA level NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B

SVR12 was defined as plasma HCV RNA level NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug

Trials

3 trials available for benzimidazole and Cirrhosis, Liver