Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-003836-39 |
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
This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T12PR24 (eRVR+) | Experimental | Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group |
|
| T12PR48 (eRVR+) | Experimental | Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group |
|
| T12PR48 (eRVR-) | Experimental | Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group |
|
| Other | Experimental | Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telaprevir | Drug | 750 mg every 8 hours (q8h) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) | SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL). | 24 weeks after the last planned dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 | SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits. | 72 weeks after the last planned dose of study treatment |
| Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Adler, MD, PhD | Erasmus Hospital Bruxelles | Principal Investigator |
| Hendrik Reesink, MD, PhD | Academic Medical Center of the University of Amsterdam | Principal Investigator |
| Kenneth Sherman, MD, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21916639 | Derived | Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, Fried MW, Adler M, Reesink HW, Martin M, Sankoh AJ, Adda N, Kauffman RS, George S, Wright CI, Poordad F; ILLUMINATE Study Team. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011 Sep 15;365(11):1014-24. doi: 10.1056/NEJMoa1014463. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | T12PR24 (eRVR+) | Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group |
| FG001 | T12PR48 (eRVR+) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ribavirin | Drug | 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks |
|
|
| peginterferon alfa-2a | Biological | 180 mcg/week for either 24 or 48 weeks |
|
|
Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment). |
| Week 4 and Week 12 |
| Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment | SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment. | 12 weeks after last dose of study treatment |
| Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively) | Week 24 or Week 48 |
| Proportion of Randomized Subjects Who Relapse | Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT). | From EOT to Week 48 or Week 72 |
| Proportion of Enrolled Subjects Who Relapse | Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up. | From EOT to Week 48 or Week 72 |
| Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 72 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Phoenix | Arizona | 85054 | United States |
| Fresno | California | 93721 | United States |
| La Jolla | California | 92037 | United States |
| Los Angeles | California | 90048 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92115 | United States |
| San Diego | California | 92123 | United States |
| San Francisco | California | 94115 | United States |
| San Francisco | California | 94143 | United States |
| Aurora | Colorado | 80045 | United States |
| Farmington | Connecticut | 06030 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Gainesville | Florida | 32610 | United States |
| Jacksonville | Florida | 32224 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Sarasota | Florida | 34243 | United States |
| Wellington | Florida | 33414 | United States |
| Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30309 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Chicago | Illinois | 60611 | United States |
| Chicago | Illinois | 60612 | United States |
| Downers Grove | Illinois | 60515 | United States |
| Indianapolis | Indiana | 46202 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21287 | United States |
| Hyattsville | Maryland | 20783 | United States |
| Laurel | Maryland | 20707 | United States |
| Boston | Massachusetts | 02111 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02215 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Detroit | Michigan | 48202 | United States |
| Novi | Michigan | 48377 | United States |
| Rochester | Minnesota | 55905 | United States |
| Kansas City | Missouri | 64131 | United States |
| St Louis | Missouri | 63104 | United States |
| St Louis | Missouri | 63110 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Atlantic City | New Jersey | 08401 | United States |
| Egg Harbor | New Jersey | 08234 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Bayside | New York | 11358 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10021 | United States |
| New York | New York | 10029 | United States |
| New York | New York | 10032 | United States |
| The Bronx | New York | 10467 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Durham | North Carolina | 27710 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Cleveland | Ohio | 44109 | United States |
| Portland | Oregon | 97239 | United States |
| Philadelphia | Pennsylvania | 19141 | United States |
| Providence | Rhode Island | 02905 | United States |
| Columbia | South Carolina | 29204 | United States |
| Germantown | Tennessee | 38138 | United States |
| Dallas | Texas | 75203 | United States |
| Dallas | Texas | 75246 | United States |
| San Antonio | Texas | 78215 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Falls Church | Virginia | 22042 | United States |
| Seattle | Washington | 98104 | United States |
| Tacoma | Washington | 98405 | United States |
| Madison | Wisconsin | 53792 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Brussels | B1070 | Belgium |
| Brussels | B1200 | Belgium |
| Ghent | 9000 | Belgium |
| Liège | 4000 | Belgium |
| Amsterdam | 1081 HV | Netherlands |
| Amsterdam | 1100 DE | Netherlands |
| Arnhem | 6815 AD | Netherlands |
| Santurce | 00909 | Puerto Rico |
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group |
| FG002 | T12PR48 (eRVR-) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group |
| FG003 | Other | Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T12PR24 (eRVR+) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group |
| BG001 | T12PR48 (eRVR+) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group |
| BG002 | T12PR48 (eRVR-) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group |
| BG003 | Other | Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen. |
| BG004 | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) | SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL). | The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug. | Posted | Number | participants | 24 weeks after the last planned dose of study treatment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 | SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits. | The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug. | Posted | Number | participants | 72 weeks after the last planned dose of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 | Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment). | The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug. | Posted | Number | participants | Week 4 and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment | SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment. | The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug. | Posted | Number | participants | 12 weeks after last dose of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively) | Posted | Number | participants | Week 24 or Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Randomized Subjects Who Relapse | Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT). | The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug. | Posted | Number | participants | From EOT to Week 48 or Week 72 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Enrolled Subjects Who Relapse | Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up. | The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug. | Posted | Number | participants | From EOT to Week 48 or Week 72 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | The population analyzed included all subjects who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to Week 72 |
|
Not provided
Not provided
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 | T12PR24 (eRVR+) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group | 4 | 162 | 161 | 162 | ||
| EG001 | T12PR48 (eRVR+) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group | 16 | 160 | 160 | 160 | ||
| EG002 | T12PR48 (eRVR-) | Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group | 7 | 118 | 117 | 118 | ||
| EG003 | Other | Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen. | 22 | 100 | 99 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders |
| |||
| ANAEMIA HAEMOLYTIC AUTOIMMUNE | Blood and lymphatic system disorders |
| |||
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders |
| |||
| LYMPHOPENIA | Blood and lymphatic system disorders |
| |||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders |
| |||
| PNEUMONIA | Infections and infestations |
| |||
| APPENDICITIS | Infections and infestations |
| |||
| BACTERAEMIA | Infections and infestations |
| |||
| BACTERIAL INFECTION | Infections and infestations |
| |||
| BURSITIS INFECTIVE | Infections and infestations |
| |||
| GASTROENTERITIS | Infections and infestations |
| |||
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations |
| |||
| SINUSITIS | Infections and infestations |
| |||
| STAPHYLOCOCCAL INFECTION | Infections and infestations |
| |||
| NAUSEA | Gastrointestinal disorders |
| |||
| PANCREATITIS ACUTE | Gastrointestinal disorders |
| |||
| VARICES OESOPHAGEAL | Gastrointestinal disorders |
| |||
| ALCOHOL POISONING | Injury, poisoning and procedural complications |
| |||
| JOINT DISLOCATION | Injury, poisoning and procedural complications |
| |||
| SPLENIC RUPTURE | Injury, poisoning and procedural complications |
| |||
| DEHYDRATION | Metabolism and nutrition disorders |
| |||
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders |
| |||
| CRYPTOGENIC ORGANISING PNEUMONIA | Respiratory, thoracic and mediastinal disorders |
| |||
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders |
| |||
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders |
| |||
| ATRIAL FIBRILLATION | Cardiac disorders |
| |||
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders |
| |||
| PAPILLOEDEMA | Eye disorders |
| |||
| RETINOPATHY | Eye disorders |
| |||
| BILE DUCT STONE | Hepatobiliary disorders |
| |||
| LIVER DISORDER | Hepatobiliary disorders |
| |||
| BREAST NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| THROAT CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| MANIA | Psychiatric disorders |
| |||
| MENTAL STATUS CHANGES | Psychiatric disorders |
| |||
| ANGIOEDEMA | Skin and subcutaneous tissue disorders |
| |||
| RASH | Skin and subcutaneous tissue disorders |
| |||
| DEEP VEIN THROMBOSIS | Vascular disorders |
| |||
| HAEMORRHAGIC ARTERIOVENOUS MALFORMATION | Congenital, familial and genetic disorders |
| |||
| VERTIGO | Ear and labyrinth disorders |
| |||
| NON-CARDIAC CHEST PAIN | General disorders |
| |||
| HYPERSENSITIVITY | Immune system disorders |
| |||
| POLYMYOSITIS | Musculoskeletal and connective tissue disorders |
| |||
| MIGRAINE | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders |
| |||
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (11.0) |
| ||
| CHILLS | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| PYREXIA | General disorders |
| |||
| IRRITABILITY | General disorders |
| |||
| INJECTION SITE ERYTHEMA | General disorders |
| |||
| PAIN | General disorders |
| |||
| OEDEMA PERIPHERAL | General disorders |
| |||
| INJECTION SITE RASH | General disorders |
| |||
| INJECTION SITE REACTION | General disorders |
| |||
| MALAISE | General disorders |
| |||
| PRURITUS | Skin and subcutaneous tissue disorders |
| |||
| RASH | Skin and subcutaneous tissue disorders |
| |||
| ALOPECIA | Skin and subcutaneous tissue disorders |
| |||
| DRY SKIN | Skin and subcutaneous tissue disorders |
| |||
| RASH MACULO-PAPULA | Skin and subcutaneous tissue disorders |
| |||
| RASH PAPULAR | Skin and subcutaneous tissue disorders |
| |||
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders |
| |||
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders |
| |||
| RASH MACULAR | Skin and subcutaneous tissue disorders |
| |||
| ERYTHEMA | Skin and subcutaneous tissue disorders |
| |||
| NAUSEA | Gastrointestinal disorders |
| |||
| DIARRHOEA | Gastrointestinal disorders |
| |||
| VOMITING | Gastrointestinal disorders |
| |||
| ANORECTAL DISCOMFORT | Gastrointestinal disorders |
| |||
| HAEMORRHOIDS | Gastrointestinal disorders |
| |||
| DYSPEPSIA | Gastrointestinal disorders |
| |||
| CONSTIPATION | Gastrointestinal disorders |
| |||
| DRY MOUTH | Gastrointestinal disorders |
| |||
| ABDOMINAL PAIN | Gastrointestinal disorders |
| |||
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders |
| |||
| ANAL PRURITUS | Gastrointestinal disorders |
| |||
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders |
| |||
| RECTAL HAEMORRHAGE | Gastrointestinal disorders |
| |||
| TOOTHACHE | Gastrointestinal disorders |
| |||
| HEADACHE | Nervous system disorders |
| |||
| DIZZINESS | Nervous system disorders |
| |||
| DYSGEUSIA | Nervous system disorders |
| |||
| DISTURBANCE IN ATTENTION | Nervous system disorders |
| |||
| HYPOAESTHESIA | Nervous system disorders |
| |||
| PARAESTHESIA | Nervous system disorders |
| |||
| INSOMNIA | Psychiatric disorders |
| |||
| DEPRESSION | Psychiatric disorders |
| |||
| ANXIETY | Psychiatric disorders |
| |||
| SLEEP DISORDER | Psychiatric disorders |
| |||
| ANAEMIA | Blood and lymphatic system disorders |
| |||
| NEUTROPENIA | Blood and lymphatic system disorders |
| |||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders |
| |||
| LEUKOPENIA | Blood and lymphatic system disorders |
| |||
| COUGH | Respiratory, thoracic and mediastinal disorders |
| |||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders |
| |||
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders |
| |||
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders |
| |||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders |
| |||
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders |
| |||
| MYALGIA | Musculoskeletal and connective tissue disorders |
| |||
| ARTHRALGIA | Musculoskeletal and connective tissue disorders |
| |||
| BACK PAIN | Musculoskeletal and connective tissue disorders |
| |||
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders |
| |||
| SINUSITIS | Infections and infestations |
| |||
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations |
| |||
| NASOPHARYNGITIS | Infections and infestations |
| |||
| BRONCHITIS | Infections and infestations |
| |||
| URINARY TRACT INFECTION | Infections and infestations |
| |||
| DECREASED APPETITE | Metabolism and nutrition disorders |
| |||
| ANOREXIA | Metabolism and nutrition disorders |
| |||
| HYPOKALAEMIA | Metabolism and nutrition disorders |
| |||
| VISION BLURRED | Eye disorders |
| |||
| DRY EYE | Eye disorders |
| |||
| WEIGHT DECREASED | Investigations |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Kauffman, MD, PhD | Vertex Pharmaceuticals Incorporated | 617-444-6158 | Robert_Kauffman@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 |
|---|---|
| C486464 | telaprevir |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| 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 |
|
| SVR24 (Statistical Analysis 2) |
|
| SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24. | Difference in proportions | 2.0 | 2-Sided | 95 | -4.3 | 8.2 | Non-Inferiority or Equivalence (legacy) | Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%). |
| OG003 |
| Other |
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen |
|
|
|
| Other |
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen |
|
|
| OG003 |
| Other |
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Other | Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen |
|
|
| OG003 |
| Other |
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen |
|
|
|
|