| ID | Type | Description | Link |
|---|---|---|---|
| VX-950-TiDP24-C209 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Experimental | Participants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of pegylated interferon 180 microgram (mcg) will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks. |
|
| TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Experimental | Participants who are never treated for CHC genotype 2 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
|
| Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Active Comparator | Participants who are never treated for CHC genotype 2 will receive TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir | Drug | Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology. | Baseline, Pre-dose (Day 15) |
| Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml). | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr]) |
| Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax. | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clichy | France | |||||
Out of 26 participants infected with genotype 2 hepatitis C virus (HCV) who were randomly assigned to treatment, only 23 participants received treatment. 2 participants withdrew and 1 participant was infected with HCV genotype 4. All the 26 participants infected with genotype 3 HCV received treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Experimental | Participants who are never treated for CHC genotype 3 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks. |
|
| TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Experimental | Participants who are never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
|
| Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Active Comparator | Participants who are never treated for CHC genotype 3 will receive TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
|
|
| Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) | Drug | Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group. |
|
| Placebo | Drug | Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks. |
|
Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Baseline and Week 24/26 |
| Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml. | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml. | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable). | Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation) |
| Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | Baseline up to EOT |
| Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | Baseline, Day 12, 15 and Week 24/26 |
| Percentage of Participants Who Demonstrated Virological Relapse | Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | 24 weeks after EOT |
| Percentage of Participants Who Achieved Sustained Virological Response (SVR) | The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | Week 12, 24 after EOT |
| Créteil |
| France |
| Lyon | France |
| Paris | France |
| Vandœuvre-lès-Nancy | France |
| Stockholm | Sweden |
| London | United Kingdom |
| FG001 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| FG002 | Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| FG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| FG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| FG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| BG001 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| BG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| BG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| BG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| BG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| BG006 | 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 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology. | Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo. | Posted | Median | Full Range | log10 IU/ml | Baseline, Pre-dose (Day 15) |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml). | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr]) |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Median | Full Range | hr | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng*hr/ml | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Median | Full Range | log10 IU/ml | Baseline and Week 24/26 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng*hr/ml | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable). | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points. | Posted | Number | percentage of participants | Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. | Posted | Median | Full Range | days | Baseline up to EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. | Posted | Number | percentage of participants | Baseline, Day 12, 15 and Week 24/26 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Demonstrated Virological Relapse | Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Number | percentage of participants | 24 weeks after EOT |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. | The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. | Posted | Number | percentage of participants | Week 12, 24 after EOT |
|
Screening period (Week minus 6) up to 2 weeks of telaprevir treatment phase.
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 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | 0 | 9 | 6 | 9 | ||
| EG001 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 0 | 5 | 4 | 5 | ||
| EG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 0 | 9 | 8 | 9 | ||
| EG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | 0 | 8 | 7 | 8 | ||
| EG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 0 | 9 | 9 | 9 | ||
| EG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 0 | 9 | 8 | 9 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
As per revised Protocol dated 14 Feb 2008, Investigator may not submit for publication or presentation, the results of trial without prior written consent of Sponsor. The Investigator agrees to allow at least 45 days for Sponsor to review pre-publication manuscript prior to submission to Publisher. In accordance with generally recognized principles of scientific collaboration, co-authorship with any company personnel will be discussed and mutually agreed upon before submission to Publisher.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen Research & Development, LLC | 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 |
|
| Italy |
|
| Sweden |
|
| United Kingdom |
|
| Change at Day 15 |
|
| OG002 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG003 | TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG003 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG003 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG003 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG003 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG003 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 |
Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|
| OG002 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG003 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. |
| OG004 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| OG005 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
|
|