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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005190-23 | EudraCT Number |
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The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may be staggered.
Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).
Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants, the mean maximum reduction in HCV viral load is greater following multiple dose oral administration of elbasvir as compared to placebo.
Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT1 HCV 10-mg Elbasvir (Panel A) | Experimental | Participants with GT1 HCV receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
|
| GTI HCV 50-g Elbasvir (Panel B) | Experimental | Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
|
| GT1 HCV 5-mg Elbavir (Panel C) | Experimental | Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
|
| GT1 HCV 200-mg Elbasvir (Panel D) | Experimental | Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
|
| GT3 HCV 10-mg Elbasvir (Panel E) | Experimental | Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbasvir | Drug | Elbasvir was administered orally by tablet(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 | HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction. | Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 |
| Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 | HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction | Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 |
| Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a | HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction. | Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 |
| Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 | HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26303801 | Background | Liu R, Curry S, McMonagle P, Yeh WW, Ludmerer SW, Jumes PA, Marshall WL, Kong S, Ingravallo P, Black S, Pak I, DiNubile MJ, Howe AY. Susceptibilities of genotype 1a, 1b, and 3 hepatitis C virus variants to the NS5A inhibitor elbasvir. Antimicrob Agents Chemother. 2015 Nov;59(11):6922-9. doi: 10.1128/AAC.01390-15. Epub 2015 Aug 24. | |
| 29703432 |
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2 Panels (Panel D in Part 1 and Panel H in Part 2) were planned but not performed. No participants were enrolled in either of these panels.
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| ID | Title | Description |
|---|---|---|
| FG000 | GT1 HCV 10-mg Elbasvir (Panel A) | Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| FG001 | GT1 HCV 50-g Elbasvir (Panel B) | Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| FG002 | GT1 HCV 5-mg Elbasvir (Panel C) | Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| FG003 | GT1 HCV 200-mg Elbasvir (Panel D) | Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| FG004 | GT3 HCV 10-mg Elbasvir (Panel E) | Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| FG005 | GT3 HCV 50-mg Elbasvir (Panel F) | Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| FG006 | GT3 HCV 100-mg Elbasvir (Panel G) | Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| FG007 | GT3 HCV 200-mg Elbasvir (Panel H) | Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| FG008 | GT1a HCV 10-mg Elbasvir (Panel I) | Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. |
| FG009 | GT1a HCV 50-mg Elbasvir (Panel J) | Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
| |||||||||||||
| Part 2 |
| |||||||||||||
| Part 3 |
|
All enrolled participants who received at least one dose of study drug. Participants who received placebo in Part 1, 2, or 3 are grouped together regardless of HCV GT or randomly assigned panel. 2 Panels (Panel D in Part 1 and Panel H in Part 2) were planned but not performed. No participants were enrolled in either of these panels.
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| ID | Title | Description |
|---|---|---|
| BG000 | GT1 HCV 10-mg Elbasvir (Panel A) | Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study. |
| BG001 | GT1 HCV 50-g Elbasvir (Panel B) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 | HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction. | All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted. | Posted | Least Squares Mean | 95% Confidence Interval | IU/mL | Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 |
|
Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-mg Elbasvir | Participants with HCV GT1 who received 5 -mg elbasvir |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D007239 | Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000589335 | elbasvir |
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| GT3 HCV 50-mg Elbasvir (Panel F) | Experimental | Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
|
| GT3 HCV 100-mg Elbasvir (Panel G) | Experimental | Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
|
| GT3 HCV 200-mg Elbasvir (Panel H) | Experimental | Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
|
| GT1a HCV 10-mg Elbasvir (Panel I) | Experimental | Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. |
|
| GT1a HCV 50-mg Elbasvir (Panel J) | Experimental | Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. |
|
| Placebo | Drug | Dose-matched placebo tablets were administered orally. |
|
| Up to 5 days |
| Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 | HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded. | Up to 5 days |
| Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a | HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded. | Up to 5 days |
| Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. | Up to 5 days |
| Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded. | Up to 5 days |
| Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
| BG002 | GT1 HCV 5-mg Elbasvir (Panel C) | Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study. |
| BG003 | GT3 HCV 10-mg Elbasvir (Panel E) | Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study. |
| BG004 | GT3 HCV 50-mg Elbasvir (Panel F) | Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study. |
| BG005 | GT3 HCV 100-mg Elbasvir (Panel G) | Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study. |
| BG006 | GT1a HCV 10-mg Elbasvir (Panel I) | Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study. |
| BG007 | GT1a HCV 50-mg Elbasvir (Panel J) | Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study. |
| BG008 | Placebo | Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| GT1 HCV 10-mg Elbasvir (Panel A) |
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study. |
| OG001 | GT1 HCV 50-g Elbasvir (Panel B) | Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| OG002 | GT1 HCV 5-mg Elbasvir (Panel C) | Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| OG003 | Placebo | Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study. |
|
|
|
| Primary | Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 | HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction | All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted. | Posted | Least Squares Mean | 95% Confidence Interval | IU/mL | Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 |
|
|
|
|
| Primary | Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a | HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction. | All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. | Posted | Least Squares Mean | 95% Confidence Interval | IU/mL | Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 |
|
|
|
|
| Primary | Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 | HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded. | All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted. | Posted | Least Squares Mean | 95% Confidence Interval | IU/mL | Up to 5 days |
|
|
|
|
| Primary | Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 | HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded. | All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted. | Posted | Least Squares Mean | 95% Confidence Interval | IU/mL | Up to 5 days |
|
|
|
|
| Primary | Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a | HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded. | All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. | Posted | Least Squares Mean | 95% Confidence Interval | IU/mL | Up to 5 days |
|
|
|
|
| Primary | Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. | All participants who received at least 1 dose of study drug. Events reported by drug taken at time of event and not by panel or genotype | Posted | Number | Participants | Up to 5 days |
|
|
|
| Primary | Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded. | All participants who received at least 1 dose of study drug. Event summarized by drug taken at time of event and not by panel or genotype | Posted | Number | Participants | Up to 5 days |
|
|
|
| 0 |
| 5 |
| 4 |
| 5 |
| EG001 | 10-g Elbasvir | Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir | 0 | 15 | 6 | 15 |
| EG002 | 50-mg Elbasvir | Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir | 0 | 15 | 7 | 15 |
| EG003 | 100-mg Elbasvir | Participants with HCV GT3 who received 100-mg elbasvir | 0 | 5 | 1 | 5 |
| EG004 | Placebo | Participants with HCV GT1, GT3 or GT1a who received placebo during. | 0 | 8 | 4 | 8 |
| EG005 | Post-Study | All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study | 0 | 48 | 0 | 48 |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
| D004066 |
| Digestive System Diseases |
| Difference in LS Means |
| 2.07 |
| 2-Sided |
| 90 |
| 1.39 |
| 2.74 |
| Superiority or Other |
| Difference in LS Means | 2.72 | 2-Sided | 90 | 2.05 | 3.39 | Superiority or Other |
| Difference in LS Means |
| 3.95 |
| 2-Sided |
| 90 |
| 3.44 |
| 4.47 |
| Superiority or Other |
| Difference in LS Means |
| 4.67 |
| 2-Sided |
| 90 |
| 3.98 |
| 5.36 |
| Superiority or Other |
| Difference in LS Means | 3.61 | 2-Sided | 90 | 2.92 | 4.30 | Superiority or Other |
| Difference in LS Means |
| 2.57 |
| 2-Sided |
| 90 |
| 1.75 |
| 3.39 |
| Superiority or Other |
| Difference in LS Means | 2.84 | 2-Sided | 90 | 2.02 | 3.66 | Superiority or Other |
| Difference in LS Means |
| 3.63 |
| 2-Sided |
| 90 |
| 3.00 |
| 4.26 |
| Superiority or Other |