Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00758043 | A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response | PHASE3 | COMPLETED | 540 | — | — | Oct 1, 2008 | Jul 1, 2010 | Mar 26, 2021 | 82 | United States, Belgium +2 |
| NCT00892697 | Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV) | PHASE2 | COMPLETED | 15 | — | — | May 1, 2009 | Dec 1, 2012 | Mar 20, 2015 | - | — |
| NCT00535847 | A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy | PHASE2 | COMPLETED | 117 | — | — | Oct 1, 2007 | Feb 1, 2010 | Aug 5, 2014 | 62 | United States, Austria +6 |
| NCT00420784 | A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3) | PHASE2 | COMPLETED | 465 | — | — | Feb 1, 2007 | Apr 1, 2009 | Aug 5, 2014 | 53 | United States, Canada +3 |
| NCT01275599 | Drug-Drug Interaction Study Between Telaprevir and Buprenorphine | PHASE1 | COMPLETED | 16 | — | — | Jan 1, 2011 | - | Jun 8, 2011 | 2 | United States |
| NCT01038167 | A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults | PHASE1 | COMPLETED | 20 | — | — | Jan 1, 2010 | Apr 1, 2010 | Apr 8, 2010 | 1 | United States |
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).
Intrahepatic viral kinetics, plasma viral kinetics,
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
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 plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Measured by maximum observed concentration (Cmax)
Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Arm | EXPERIMENTAL | 15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week | EXPERIMENTAL | 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 24 weeks. |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 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 48 weeks. |
| Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week | EXPERIMENTAL | Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 48 weeks. |
| Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week | EXPERIMENTAL | Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks. |
| PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week | PLACEBO_COMPARATOR | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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 48 weeks. |
| Open-Label Arm | EXPERIMENTAL | The treatment period will include 3 phases: * 14 day run-in period * 7 day co-administration period * 31 day follow-up period |
| Part A | EXPERIMENTAL | Part A will be administered in two periods, separated by a washout. In Period 1, subjects will receive cyclosporine alone. In Period 2, subjects will receive cyclosporine in combination with telaprevir. |
| Part B | EXPERIMENTAL | Part B will be administered in two periods, separated by a washout. In Period 1, subjects will receive tacrolimus alone. In Period 2, subjects will receive tacrolimus in combination with telaprevir. |
| Name | Type | Description |
|---|---|---|
| telaprevir | DRUG | 750 mg every 8 hours (q8h) for 12 weeks |
| 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 |
| Pegylated interferon alfa 2a | DRUG | Solution for Injection |
| Matching Placebo | DRUG | Tablet |
| buprenorphine/naloxone | DRUG | Buprenorphine/naloxone sublingual tablets or films contain buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine:naloxone (ratio of free bases). In this study buprenorphine/naloxone will be dosed from Day -14 through Day 38, inclusive. From Day -14 through Day -1 all subjects will receive a maximum of 24 mg/6 mg of buprenorphine/naloxone. Subjects will not be permitted to change their dose during the telaprevir co-administration period (Day 1 through Day 7) unless warranted by the investigator's clinical judgment of subject safety. After Day 8, the dose of buprenorphine/naloxone may be adjusted if deemed necessary by the investigator. |
| cyclosporine | DRUG | Solution, Oral, 100mg, Day 1 of Period 1 |
| tacrolimus | DRUG | Capsule, Oral, 2mg, Day 1 of Period 1 |
Inclusion Criteria: * Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C * Male and female subjects, 18 to 70 years of age, inclusive * Genotype 1, chronic hepatitis C with detectable HCV RNA. * Screening laboratory val...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |