A Phase 2/3 interventional study of Grazoprevir and Elbasvir in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-24.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2/3, Interventional, and Treatment
This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose determined in Part I in combination with elbasvir. The primary study hypothesis is that the percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be greater than the reference rate of 75%. A separate study arm for cirrhotic participants will also be included in Part II; these participants will receive grazoprevir at the determined dose in combination with elbasvir.
In Part 1, HCV GT1 participants are randomized into one of two arms: 50 mg grazoprevir plus 50 mg elbasvir for 12 weeks during the double blinded (DB) period followed by 24 weeks of follow-up (FU) during an open-label (OL) period [Arm 1]; or 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks during the DB followed by 24 weeks of FU during the OL [Arm 2]. Unblinding will occur after all participants complete FU Week 4 at which time the grazoprevir dose will be selected.
In Part 2, non-cirrhotic HCV GT1 participants and GT1 participants with compensated liver cirrhosis all receive the selected dose of grazoprevir (50 mg or 100 mg from Part 1) with 50 mg elbasvir for 12 weeks. Non-cirrhotic GT1 participants are randomized to receive either a) 12 weeks of active treatment immediately during the DB with 24 weeks of FU in the OL [Arm 1/Immediate Arm] or b) placebo for 12 weeks with 4 weeks of follow-up during the DB followed by 12 weeks of active treatment and 24 weeks of follow-up during the OL [Arm 2/Deferred Arm]. All cirrhotic participants [Arm 3/Cirrhotic] receive the selected dose immediately for 12 weeks during the DB with 24 weeks of FU during the OL.
Safety analyses for Part 1 and Part 2 arms will focus on the 12 week treatment phase plus the first 4 FU weeks. For the Part 2 Deferred Arm this will include the initial 12 week placebo treatment and first 4 weeks of FU. Efficacy analyses for Parts 1 and 2 will evaluate active treatment only (Weeks 1-12 for all arms except for Part 2 Deferred Arm which is weeks 16-28).
Part 1:
50 mg grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 1) 100 mg grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 2)
Part 2:
Selected dose of grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 1/Immediate) Placebo treatment for 12 weeks, 4 weeks follow-up, selected dose of grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 2/Deferred) Selected dose of grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 3/Cirrhotic)
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 399 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir by mouth (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
Drug: Grazoprevir · Drug: Elbasvir · Drug: Placebo to Grazoprevir
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
Drug: Grazoprevir · Drug: Elbasvir
Non-cirrhotic participants take grazoprevir (50 mg or 100 mg dose selected from Part I) and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2 and are followed-up for 24 weeks during the open-label period of Part 2.
Drug: Grazoprevir · Drug: Elbasvir
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take grazoprevir (50 mg or 100 mg dose selected from Part I) and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
Drug: Grazoprevir · Drug: Elbasvir · Drug: Placebo to Grazoprevir · Drug: Placebo to Elbasvir
Cirrhotic participants take grazoprevir (50 mg or 100 mg dose selected from Part 1) and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
Drug: Grazoprevir · Drug: Elbasvir
One or two 50 mg tablets (depending on randomization) taken orally once daily for 12 weeks.
One 50 mg tablet taken orally once daily for 12 weeks.
One tablet of placebo matched to grazoprevir, taken orally once daily for 12 weeks.
One tablet of placebo matched to elbasvir, taken orally once daily for 12 weeks.
Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.
Time frame: 12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)
Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).
Time frame: Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)
Part 1: Percentage of Participants That Discontinued Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.
Time frame: Up to Study Week 12 in Part 1
Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
Time frame: Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)
Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
Time frame: Up to Study Week 12 in Part 2
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Time frame: Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Time frame: Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Time frame: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Time frame: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
| Milestone | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|---|---|
| Started | 31 | 32 | 0 | 0 | 0 |
| Completed | 31 | 31 | 0 | 0 | 0 |
| Not completed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 0 |
| Milestone | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|---|---|
| Started | 0 | 0 | 227 | 74 | 35 |
| Started deferred active treatment | 0 | 0 | 0 | 73 | 0 |
| Completed | 0 | 0 | 226 | 71 | 34 |
| Not completed | 0 | 0 | 1 | 3 | 1 |
| Withdrew: Death | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 1 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.
| percentage of participants | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|---|---|
| Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12) | — | — | 96.6 (92.3 to 98.9) | — | — |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).
| percentage of participants | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir |
|---|---|---|
| Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks | 67.7 | 74.2 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.
| percentage of participants | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir |
|---|---|---|
| Part 1: Percentage of Participants That Discontinued Treatment Due to an AE | 0.0 | 0.0 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
| percentage of participants | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir |
|---|---|---|
| TW2 | 22.6 (9.6 to 41.1) | 35.5 (19.2 to 54.6) |
| TW4 | 77.4 (58.9 to 90.4) | 83.9 (66.3 to 94.5) |
| TW12 | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| EOT | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| FUWK4 | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| FUWK12 | 100.0 (88.8 to 100.0) | 96.8 (83.3 to 99.9) |
| FUWK24 | 96.8 (83.3 to 99.9) | 96.8 (83.3 to 99.9) |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
| percentage of participants | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir |
|---|---|---|
| TW2 | 61.3 (42.2 to 78.2) | 71.0 (52.0 to 85.8) |
| TW4 | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| TW12 | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| EOT | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| FUWK4 | 100.0 (88.8 to 100.0) | 100.0 (88.8 to 100.0) |
| FUWK12 | 100.0 (88.8 to 100.0) | 96.8 (83.3 to 99.9) |
| FUWK24 | 100.0 (88.8 to 100.0) | 96.8 (83.3 to 99.9) |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
| percentage of participants | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|
| Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks | 64.8 | 67.6 | 80.0 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
| percentage of participants | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|
| Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE | 1.3 | 1.4 | 0.0 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
| percentage of participants | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|
| TW2 | 25.1 (19.6 to 31.3) | 39.7 (28.5 to 51.9) | 11.4 (3.2 to 26.7) |
| TW4 | 70.5 (64.1 to 76.3) | 86.3 (76.2 to 93.2) | 65.7 (47.8 to 80.9) |
| TW12 | 97.8 (94.9 to 99.3) | 100.0 (95.1 to 100.0) | 100.0 (90.0 to 100.0) |
| EOT | 98.7 (96.2 to 99.7) | 100.0 (95.1 to 100.0) | 100.0 (90.0 to 100.0) |
| FUWK4 | 98.2 (95.5 to 99.5) | 100.0 (95.1 to 100.0) | 97.1 (85.1 to 99.9) |
| FUWK12 | 96.5 (93.2 to 98.5) | 95.9 (88.5 to 99.1) | 97.1 (85.1 to 99.9) |
| FUWK24 | 96.5 (93.2 to 98.5) | 95.9 (88.5 to 99.1) | 94.3 (80.8 to 99.3) |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
| percentage of participants | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|
| TW2 | 60.8 (54.1 to 67.2) | 69.9 (58.0 to 80.1) | 60.0 (42.1 to 76.1) |
| TW4 | 96.0 (92.6 to 98.2) | 98.6 (92.6 to 100.0) | 94.3 (80.8 to 99.3) |
| TW12 | 98.7 (96.2 to 99.7) | 100.0 (95.1 to 100.0) | 100.0 (90.0 to 100.0) |
| EOT | 99.6 (97.6 to 100.0) | 100.0 (95.1 to 100.0) | 100.0 (90.0 to 100.0) |
| FUWK4 | 98.2 (95.5 to 99.5) | 100.0 (95.1 to 100.0) | 97.1 (85.1 to 99.9) |
| FUWK12 | 96.5 (93.2 to 98.5) | 97.3 (90.5 to 99.7) | 97.1 (85.1 to 99.9) |
| FUWK24 | 96.5 (93.2 to 98.5) | 95.9 (88.5 to 99.1) | 97.1 (85.1 to 99.9) |
Collected over Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1 Grazoprevir 50 mg + Elbasvir | — | 2/31 (6.5%) | 16/31 (51.6%) |
| Part 1 Grazoprevir 100 mg + Elbasvir | — | 1/31 (3.2%) | 17/31 (54.8%) |
| Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | — | 19/227 (8.4%) | 109/227 (48%) |
| Part 2 Non-cirrhotic Deferred: Placebo | — | 1/74 (1.4%) | 27/74 (36.5%) |
| Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | — | 2/73 (2.7%) | 42/73 (57.5%) |
| Part 2 Cirrhotic: Grazoprevir + Elbasvir | — | 3/35 (8.6%) | 27/35 (77.1%) |
| Event | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo | Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|---|---|---|
| Acute coronary syndromeCardiac disorders | 1/31 | 0/31 | 0/227 | 0/74 | 0/73 | 0/35 |
| HaematocheziaGastrointestinal disorders | 0/31 | 1/31 | 0/227 | 0/74 | 0/73 | 0/35 |
| Large intestine polypGastrointestinal disorders | 0/31 | 1/31 | 1/227 | 0/74 | 1/73 | 0/35 |
| Adenocarcinoma of colonNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/31 | 0/31 | 0/227 | 0/74 | 0/73 | 0/35 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/31 | 0/31 | 0/227 | 0/74 | 0/73 | 1/35 |
| Gastrointestinal tract adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/31 | 0/31 | 0/227 | 0/74 | 0/73 | 1/35 |
| Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/31 | 0/31 | 1/227 | 1/74 | 0/73 | 1/35 |
| Colitis ischaemicGastrointestinal disorders | 0/31 | 0/31 | 0/227 | 0/74 | 1/73 | 0/35 |
| CataractEye disorders | 0/31 | 0/31 | 3/227 | 0/74 | 0/73 | 0/35 |
| Cardiac sarcoidosisCardiac disorders | 0/31 | 0/31 | 1/227 | 0/74 | 0/73 | 0/35 |
| Event | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo | Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir |
|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 8/31 | 11/31 | 47/227 | 12/74 | 20/73 | 8/35 |
| Aspartate aminotransferase increasedInvestigations | 0/31 | 0/31 | 10/227 | 2/74 | 3/73 | 6/35 |
| HeadacheNervous system disorders | 5/31 | 3/31 | 11/227 | 2/74 | 2/73 | 2/35 |
| Alanine aminotransferase increasedInvestigations | 1/31 | 0/31 | 12/227 | 1/74 | 3/73 | 5/35 |
| PyrexiaGeneral disorders | 3/31 | 1/31 | 3/227 | 1/74 | 3/73 | 1/35 |
| ConstipationGastrointestinal disorders | 0/31 | 1/31 | 11/227 | 3/74 | 4/73 | 3/35 |
| DiarrhoeaGastrointestinal disorders | 2/31 | 1/31 | 12/227 | 2/74 | 6/73 | 3/35 |
| RashSkin and subcutaneous tissue disorders | 1/31 | 0/31 | 9/227 | 1/74 | 0/73 | 3/35 |
| CystitisInfections and infestations | 0/31 | 1/31 | 8/227 | 1/74 | 6/73 | 1/35 |
| MalaiseGeneral disorders | 1/31 | 0/31 | 7/227 | 3/74 | 5/73 | 2/35 |
| Age, Continuous(years) | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir | Total |
|---|---|---|---|---|---|---|
| Mean | 61.1 ± 9.7 | 58.0 ± 12.5 | 61.1 ± 12.5 | 60.9 ± 10.8 | 64.8 ± 9.2 | 61.1 ± 11.7 |
| Sex: Female, Male(Participants) | Part 1 Grazoprevir 50 mg + Elbasvir | Part 1 Grazoprevir 100 mg + Elbasvir | Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir | Part 2 Cirrhotic: Grazoprevir + Elbasvir | Total |
|---|---|---|---|---|---|---|
| Female | 19 | 17 | 140 | 53 | 17 | 246 |
| Male | 12 | 15 | 87 | 21 | 18 | 153 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Grazoprevir · Elbasvir