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| ID | Type | Description | Link |
|---|---|---|---|
| VX-TiDP24-C219 | Other Identifier | Janssen Infectious Diseases BVBA | |
| 2009-012613-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telaprevir + Standard Treatment | Experimental | Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir | Drug | 750 mg orally every 8 hours (q8h) for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure. | End of trial (24 weeks after last dose, administerd at 48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Infectious Diseases BVBA Clinical Trial | Janssen Infectious Diseases BVBA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coronado | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25712364 | Derived | Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23. |
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This study provided participants with access to telaprevir who were randomized to the control group in a previous Phase 3 study and failed therapy with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV) or to participants who received telaprevir as monotherapy or in combination with Peg-IFN-alfa-2a in 2 previous Phase 1 studies.
A total of 90 participants were enrolled and received treatment in the study: 9 participants from Phase 1 studies VX04-950-101 or Study VX05-950-103 and 81 participants from the Phase 3 study VX-950-TiDP24-C216 (NCT00703118) (referred to as the parent studies). The current study was conducted in 16 countries including the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
| FG001 | Phase 3: T12(Q8h)/PR - Prior Null Responder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pegylated interferon (Peg-IFN) alfa-2a |
| Drug |
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks. |
|
| ribavirin (RBV) | Drug | 1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks. |
|
| Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation) |
| Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL. | Week 4, Week 8 |
| Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL. | Week 12 or Weeks 24 or 36 |
| Percentage of Participants Achieving Rapid Virologic Response (RVR) | The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).](streamdown:incomplete-link) | Week 4 |
| Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).](streamdown:incomplete-link) | Weeks 4 and 12 |
| Percentage of Participants With Viral Breakthrough | The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase. | Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase) |
| Percentage of Participants Who Relapsed During Follow-Up | The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment). | During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks) |
| Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time. | Baseline, Weeks 4, 8, 12, 24, 36, 48 |
| Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | The table below shows change from baseline in log 10 plasma HCV RNA values measured over time. | Baseline, Weeks 4, 8, 12, 24, 36, and 48 |
| Los Angeles |
| California |
| United States |
| San Francisco | California | United States |
| Bradenton | Florida | United States |
| Miami | Florida | United States |
| Atlanta | Georgia | United States |
| Indianapolis | Indiana | United States |
| Kansas City | Missouri | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Adelaide | Australia |
| Clayton | Australia |
| Darlinghurst | Australia |
| Perth | Australia |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Distrito Barao Geraldo-Campina | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Montreal | Quebec | Canada |
| Clichy | France |
| Créteil | France |
| Lille | France |
| Pessac | France |
| Berlin | Germany |
| Cologne | Germany |
| Frankfurt | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| München | Germany |
| Petah Tikva | Israel |
| Safed | Israel |
| Amsterdam | Netherlands |
| Nijmegen | Netherlands |
| Bialystok | Poland |
| Czeladź | Poland |
| Warsaw | Poland |
| San Juan | Puerto Rico |
| Barcelona | Spain |
| Valencia | Spain |
| Stockholm | Sweden |
| Zurich | Switzerland |
| London | United Kingdom |
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. |
| FG002 | Phase 3: T12(Q8h)/PR - Prior Partial Responder | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. |
| FG003 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
| BG001 | Phase 3: T12(Q8h)/PR - Prior Null Responder | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. |
| BG002 | Phase 3: T12(Q8h)/PR - Prior Partial Responder | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. |
| BG003 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| 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 | Median | Inter-Quartile Range | 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 | The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants with response | End of trial (24 weeks after last dose, administerd at 48 weeks) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants with response | Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation) |
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| Secondary | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Week 4, Week 8 |
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| Secondary | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Week 12 or Weeks 24 or 36 |
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| Secondary | Percentage of Participants Achieving Rapid Virologic Response (RVR) | The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).](streamdown:incomplete-link) | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Week 4 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).](streamdown:incomplete-link) | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Weeks 4 and 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Breakthrough | The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase) |
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| Secondary | Percentage of Participants Who Relapsed During Follow-Up | The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment). | The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug. | Posted | Number | Percentage of participants | During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks) |
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| Secondary | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Median | Full Range | Log 10 IU/mL | Baseline, Weeks 4, 8, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | The table below shows change from baseline in log 10 plasma HCV RNA values measured over time. | All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug. | Posted | Median | Full Range | log 10 IU/ml | Baseline, Weeks 4, 8, 12, 24, 36, and 48 |
|
From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. | 0 | 9 | 9 | 9 | ||
| EG001 | Phase 3: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers). | 5 | 81 | 77 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
It is the policy of the sponsor not to allow the investigators to publish their results or findings prior to the sponsor's publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher as specified in the Clinical Trial Agreement between institution/investigator and sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Research & Development, LLC | 1 609 730-3174 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
|---|---|
| C486464 | telaprevir |
| C100416 | peginterferon alfa-2a |
| 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 |
|
| North America |
|
| Other |
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| Phase 3: T12(Q8h)/PR - Prior Relapser |
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| OG002 |
| Phase 3: T12(Q8h)/PR - Prior Relapser |
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. |
|
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 27, 26, 26, 26, 24, 23, and 21, respectively. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 9, 9, 8, 7, and 7, respectively. |
|
|
| OG002 | Phase 3: T12(Q8h)/PR - Prior Relapser | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 26, 26, 26, 24, 23, and 21, respectively. |
| OG003 | Phase 1: T12(Q8h)/PR | T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 8, 7, and 7, respectively. |
|
|