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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_659 | Other Identifier | Merck Registration Number |
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The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-wk Vaniprevir 600 mg + Peg-IFN/RBV | Experimental | Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks. |
|
| 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV | Experimental | Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks. |
|
| 48-wk Vaniprevir 300 mg + Peg-IFN/RBV | Experimental | Vaniprevir 300 mg (total daily dose, taken once daily [q.d.]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
|
| 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Experimental | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaniprevir | Drug | Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. | The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure. | Up to 72 weeks |
| Number of Participants Experiencing an Adverse Event (AE) | The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product. | Up to 73 weeks |
| Number of Participants Discontinuing From Study Treatment Due to AEs | The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d. | The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined. | 72 weeks |
| Percentage of Participants Achieving cEVR |
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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 |
|---|---|---|---|
| 23439259 | Result | Lawitz E, Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Bhanja S, Barnard RJ, An D, Gress J, Hwang P, Mobashery N. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. J Hepatol. 2013 Jul;59(1):11-7. doi: 10.1016/j.jhep.2013.02.008. Epub 2013 Feb 21. | |
| 24120953 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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Non-cirrhotic (NC) and cirrhotic (C) participants were screened and enrolled separately in this study. The NC population was used for all safety, tolerability, and efficacy outcome measures. Primary analyses of the outcome measures only included the NC population. Adverse events (AEs) were monitored in both the NC and C populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | 24-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks. |
| FG001 | 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study (NC Population) |
|
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| 48-wk PBO + Peg-IFN/RBV | Placebo Comparator | PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
|
|
| Pegylated Interferon (Peg-IFN) | Drug | Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks |
|
|
| Ribavirin (RBV) | Drug | Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing <=75 kg and 1200 mg for participants weighing >75 kg. |
|
|
| Placebo (PBO) | Drug | Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks. |
|
The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis. |
| Up to Week 60 |
| Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d. | The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen. | Week 48 |
| Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Lawitz E, Zhou A, Bourque M, Bhanja S, Strizki J, Barnard RJ, Hwang PM, DiNubile MJ, Mobashery N. Combination of vaniprevir with peginterferon and ribavirin significantly increases the rate of SVR in treatment-experienced patients with chronic HCV genotype 1 infection and cirrhosis. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1029-37.e5. doi: 10.1016/j.cgh.2013.09.067. Epub 2013 Oct 10. |
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks. |
| FG002 | 48-wk Vaniprevir 300 mg + Peg-IFN/RBV | Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. |
| FG003 | 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. |
| FG004 | 48-wk PBO + Peg-IFN/RBV | PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Overall Study (C Population) |
|
|
The Baseline Population consists of all randomized C and NC participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 24-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks. |
| BG001 | 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks. |
| BG002 | 48-wk Vaniprevir 300 mg + Peg-IFN/RBV | Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. |
| BG003 | 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. |
| BG004 | 48-wk PBO + Peg-IFN/RBV | PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. | The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure. | The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. | Posted | Number | Percentage of participants | Up to 72 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing an Adverse Event (AE) | The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product. | The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment. | Posted | Number | Number of participants | Up to 73 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Discontinuing From Study Treatment Due to AEs | The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. | The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment. | Posted | Number | Number of participants | Up to 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d. | The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined. | The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. | Posted | Number | Percentage of participants | 72 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving cEVR | The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis. | The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis. | Posted | Number | Percentage of participants | Up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d. | The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen. | The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. | Posted | Number | Percentage of participants | Week 48 |
|
|
AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months.
AEs were monitored and presented for the combined NC and C participant populations.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 24-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks. | 2 | 56 | 53 | 56 | ||
| EG001 | 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks. | 5 | 56 | 56 | 56 | ||
| EG002 | 48-wk Vaniprevir 300 mg + Peg-IFN/RBV | Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. | 6 | 56 | 55 | 56 | ||
| EG003 | 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. | 9 | 61 | 61 | 61 | ||
| EG004 | 48-wk PBO + Peg-IFN/RBV | PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks. | 1 | 56 | 55 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Retinal vascular thorombosis | Eye disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (v. 15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (v. 15.0) | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (v. 15.0) | 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 |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C540393 | vaniprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Lost to Follow-up |
|
| Male |
|
| Miettinen and Nurminen method |
| <0.001 |
| Adjusted difference in percentage |
| 64.4 |
| 2-Sided |
| 95 |
| 45.2 |
| 78.3 |
Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response. |
| Superiority or Other |
| Miettinen and Nurminen | <0.001 | Adjusted difference in percentage | 59.0 | 2-Sided | 95 | 40.2 | 73.4 | Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response. | Superiority or Other |
| 48-wk Vaniprevir 300 mg + Peg-IFN/RBV |
Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
| OG003 | 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
| OG004 | 48-wk PBO + Peg-IFN/RBV | PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
|
|
| OG003 | 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
| OG004 | 48-wk PBO + Peg-IFN/RBV | PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks. |
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