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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_576 |
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The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaniprevir 200 mg + peg-IFN + ribavirin | Experimental | Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
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| Vaniprevir 600 mg + peg-IFN + ribavirin | Experimental | Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
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| Vaniprevir 1200 mg + peg-IFN + ribavirin | Experimental | Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
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| Placebo + peg-IFN + ribavirin | Placebo Comparator | Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaniprevir | Drug | Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Rapid Viral Response | Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4 | Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. | Baseline and Week 4 |
| Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4 |
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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 |
|---|---|---|---|
| 25115901 | Result | Hayashi N, Mobashery N, Izumi N. Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study. J Gastroenterol. 2015 Feb;50(2):238-48. doi: 10.1007/s00535-014-0979-2. Epub 2014 Aug 13. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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Initial treatment period (Part 1) includes up through Week 6; Extension period (Part 2) includes from Week 6 through Week 96.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaniprevir 200 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| FG001 | Vaniprevir 600 mg + Peg-IFN + Ribavirin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Period (Part 1) |
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| Pegylated Interferon (peg-IFN) | Drug | Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks |
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| Ribavirin | Drug | Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks |
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| Comparator: Placebo | Drug | Placebo to vaniprevir oral capsule twice daily for 28 days |
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Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. |
| Baseline and Week 4 |
| Change From Baseline in HCV RNA in log10 at Week 4 | Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. | Baseline and Week 4 |
| Number of Participants Who Experienced at Least One Adverse Event | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. | Up to 6 weeks |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. | Up to 6 weeks |
Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| FG002 | Vaniprevir 1200 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| FG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Period (Part 2) |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaniprevir 200 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| BG001 | Vaniprevir 600 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| BG002 | Vaniprevir 1200 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| BG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Genotype | Number | Participants |
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| 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 | Percentage of Participants Achieving Rapid Viral Response | Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data. | Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Number | Percentage of participants | Week 4 |
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| Secondary | Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4 | Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. | Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Number | Percentage of participants | Baseline and Week 4 |
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| Secondary | Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4 | Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. | Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Number | Percentage of participants | Baseline and Week 4 |
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| Secondary | Change From Baseline in HCV RNA in log10 at Week 4 | Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. | Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Mean | Standard Deviation | IU/mL in Log10 | Baseline and Week 4 |
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| Secondary | Number of Participants Who Experienced at Least One Adverse Event | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. | The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received. | Posted | Number | Participants | Up to 6 weeks |
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| Secondary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. | The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received. | Posted | Number | Participants | Up to 6 weeks |
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Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period)
All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually 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 | Vaniprevir 200 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. | 2 | 23 | 23 | 23 | ||
| EG001 | Vaniprevir 600 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. | 2 | 22 | 22 | 22 | ||
| EG002 | Vaniprevir 1200 mg + Peg-IFN + Ribavirin | Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. | 0 | 23 | 23 | 23 | ||
| EG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. | 2 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Infective spondylitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Periodontitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Eosinophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C540393 | vaniprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Withdrawal by Subject |
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| Physician Decision |
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| Lack of Efficacy |
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| Male |
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| Genotype 1b |
|
| <0.001 |
| Adjusted difference in percent |
| 74.5 |
| 2-Sided |
| 95 |
| 47.6 |
| 89.0 |
Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not). |
| Superiority or Other |
| Miettinen and Nurminen | <0.001 | Adjusted difference in percent | 55.4 | 2-Sided | 95 | 24.9 | 76.0 | Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not). | Superiority or Other |
| OG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
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|
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| OG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
|
|
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Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
| OG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
|
|
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| OG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
|
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| OG003 | Placebo + Peg-IFN + Ribavirin | Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
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