Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo Comparator | Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
|
| Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Experimental | Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
| Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Experimental | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon Alfa 2a | Biological | subcutaneous injection, 180 micrograms once per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used. | 24 weeks after last planned dose of study treatment (up to Week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Undetectable HCV RNA at Week 72 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks) |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21696307 | Derived | Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912. |
Not provided
Not provided
A total of 1095 subjects were enrolled, of which 7 subjects discontinued the study prior to study drug administration. A total of 1088 subjects started treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Telaprevir | Drug | 375 mg tablets administered orally every 8 hours at a dose of 750 mg |
|
|
| Ribavirin | Drug | 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg |
|
|
| Placebo | Other | Telaprevir matching placebo |
|
| Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. | Week 4 |
| Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12. | Week 4 and Week 12 |
| Number of Subjects With Undetectable HCV RNA at Week 12 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | Week 12 |
| Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT) | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | End of treatment (up to Week 48) |
| Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | 12 weeks after last planned dose of study treatment (up to Week 60) |
| Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | 24 weeks after last actual dose of study treatment (up to Week 72) |
| Number of Subjects With Viral Relapse Planned and Viral Relapse Actual | Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment. | After last dose of study drug up to 24 week antiviral follow-up (up to Week 72) |
| Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels | Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered. | Baseline up to Week 48 |
| Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis | FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline. | Baseline through 24 weeks after last planned dose of study treatment (up to Week 72) |
| Fatigue Severity Scale (FSS) Total Score | FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue. | Baseline, Week 4, 12, 24, 36, 48, 72 |
| Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study. | Baseline up to Week 48 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Phoenix | Arizona | 85054 | United States |
| Fresno | California | 93721 | United States |
| La Jolla | California | 92037 | United States |
| Long Beach | California | 90822 | United States |
| Los Angeles | California | 90033 | United States |
| Los Angeles | California | 90048 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92154 | United States |
| San Francisco | California | 94115 | United States |
| San Francisco | California | 94121 | United States |
| San Francisco | California | 94143 | United States |
| Aurora | Colorado | 80045 | United States |
| Gainesville | Florida | 32610 | United States |
| Jacksonville | Florida | 32224 | United States |
| Jacksonville | Florida | 32256 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Sarasota | Florida | 34243 | United States |
| South Miami | Florida | 33143 | United States |
| Atlanta | Georgia | 30308 | United States |
| Savannah | Georgia | 31405 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Chicago | Illinois | 60637 | United States |
| Carmel | Indiana | 46032 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Portland | Maine | 04102 | United States |
| Baltimore | Maryland | 21287 | United States |
| Laurel | Maryland | 20707 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02215 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Detroit | Michigan | 48202 | United States |
| Kansas City | Missouri | 64131 | United States |
| St Louis | Missouri | 63104 | United States |
| Omaha | Nebraska | 68105 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10003 | United States |
| New York | New York | 10021 | United States |
| New York | New York | 10029 | United States |
| New York | New York | 10032 | United States |
| Valhalla | New York | 10595 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Durham | North Carolina | 27710 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Cleveland | Ohio | 44195 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Columbia | South Carolina | 29204 | United States |
| Germantown | Tennessee | 38138 | United States |
| Dallas | Texas | 75203 | United States |
| Dallas | Texas | 75246 | United States |
| Dallas | Texas | 75390 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78215 | United States |
| Annandale | Virginia | 22003 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Richmond | Virginia | 23249 | United States |
| Buenos Aires | Argentina |
| Darlinghurst | Australia |
| Fitzroy | Australia |
| Greenslopes | Australia |
| Melbourne | Australia |
| Perth | Australia |
| Westmead | Australia |
| Woolloongabba | Australia |
| Linz | Austria |
| Vienna | Austria |
| Calgary | Canada |
| Toronto | Canada |
| Vancouver | Canada |
| Winnipeg | Canada |
| Clichy | France |
| Créteil | France |
| Grenoble | France |
| Lyon | France |
| Nice | France |
| Paris | France |
| Pessac | France |
| Toulouse | France |
| Berlin | Germany |
| Bochum | Germany |
| Cologne | Germany |
| Düsseldorf | Germany |
| Frankfurt | Germany |
| Freiburg im Breisgau | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| München | Germany |
| Haifa | Israel |
| Jerusalem | Israel |
| Nazareth | Israel |
| Petah Tikva | Israel |
| Tel Litwinsky | Israel |
| Bologna | Italy |
| Milan | Italy |
| Torino | Italy |
| Bialystok | Poland |
| Czeladź | Poland |
| Kielce | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Wroclaw | Poland |
| Santurce | 00909 | Puerto Rico |
| Barcelona | Spain |
| Valencia | Spain |
| Glasgow | United Kingdom |
| Hampstead | United Kingdom |
| London | United Kingdom |
| FG001 | Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| FG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
| BG001 | Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| BG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Subjects With Undetectable HCV RNA at Week 72 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | Week 4 and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Undetectable HCV RNA at Week 12 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT) | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | End of treatment (up to Week 48) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | 12 weeks after last planned dose of study treatment (up to Week 60) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | 24 weeks after last actual dose of study treatment (up to Week 72) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Viral Relapse Planned and Viral Relapse Actual | Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment. | Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48). | Posted | Number | participants | After last dose of study drug up to 24 week antiviral follow-up (up to Week 72) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels | Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | Baseline up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis | FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline. | The FA set included all randomized subjects who received at least 1 dose of any study drug. Here "number of participants analyzed" signifies those subjects who were evaluable for FibroTest Analysis and "n" signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively. | Posted | Number | participants | Baseline through 24 weeks after last planned dose of study treatment (up to Week 72) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fatigue Severity Scale (FSS) Total Score | FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue. | The FA set included all randomized subjects who received at least 1 dose of any study drug. Here "n" signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, 12, 24, 36, 48, 72 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used. | The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | 24 weeks after last planned dose of study treatment (up to Week 72) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study. | The FA set included all randomized subjects who received at least 1 dose of any study drug. | Posted | Number | participants | Baseline up to Week 48 |
|
AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
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 | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. | 24 | 361 | 354 | 361 | ||
| EG001 | Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. | 31 | 364 | 362 | 364 | ||
| EG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. | 33 | 363 | 361 | 363 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| lobar pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| pyelonephritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| abscess limb | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| acute sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| cellulitis staphylococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| escherichia bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| lung abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| lymphangitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| perirectal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| staphylococcal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| staphylococcal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| subcutaneous abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| tuberculosis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anemia haemolytic | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pancytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| stevens-johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anal fistula | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| colitis ischaemic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| diverticular perforation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| internal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| intestinal ischaemia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pancreatitis acute | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| salivary gland calculus | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| altered state of consciousness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| global amnesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| completed suicide | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| panic attack | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| psychotic disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| intervertebral disc | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| retinal exudates | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| retinal haemorrhage | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| hepatic cirrhosis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| hepatitis acute | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| phlebitis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| thrombophlebitis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| non-cardiac chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| urachal abnormality | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
| |
| cryoglobulinaemia | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| thermal burn | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| metrorrhagia | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| influenza like illness | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| irritability | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| chills | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| injection site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anorectal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anal pruritus | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| distrubance in attention | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dysgeusia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| affect lability | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Chodakewitz, M.D. | Vertex Pharmaceuticals Incorporated | 617-341-6777 | Jeff_Chodakewitz@vrtx.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| C486464 | telaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Europe |
|
| Argentina |
|
| Australia |
|
| Israel |
|
| Difference in percentage |
| 29.2 |
| 2-Sided |
| 95 |
| 22.4 |
| 36.1 |
| No |
| Superiority or Other |
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
| Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week |
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
| OG002 |
| Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week |
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
| OG001 | Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
| OG001 | Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|
|
| OG001 |
| Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week |
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. |
|
|