| ID | Type | Description | Link |
|---|---|---|---|
| VX-950-TIDP24-C208 | |||
| 2007-001044-44 | EudraCT Number |
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The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.
This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet | Experimental | Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
|
| Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule | Experimental | Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
| Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet | Experimental | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
|
| Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir | Drug | Oval tablets containing 375 mg of telaprevir for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virologic Response at Week 12 | Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). | End of treatment (EOT) (up to Week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22387529 | Derived | Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2. |
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Out of 166 participants who were randomly assigned to treatment, only 161 participants received the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet | Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
| Peg-IFN-alfa-2a | Drug | Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe. |
|
| Peg-IFN-alfa-2b | Drug | Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen. |
|
| Ribavirin (RBV) tablet | Drug | Tablets containing 200 mg RBV for oral administration. |
|
| Ribavirin (RBV) capsule | Drug | Capsules containing 200 mg RBV for oral administration. |
|
| Baseline (Day 1) up to EOT (up to Week 48) |
| Number of Participants With Viral Breakthrough at End of Treatment (EOT) | Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL. | EOT (up to Week 48) |
| Percentage of Participants With Partial Response | Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples). | Baseline (Day 1) up to EOT (up to Week 48) |
| Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12 | Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration. | Baseline (pre-dose), Week 12 |
| Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT) | Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. | Baseline (pre-dose), EOT (up to Week 48) |
| Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24) | SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication. | EOT (up to Week 48) and up to 24 weeks after EOT |
| Brussels |
| Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Angers | France |
| Clichy | France |
| Grenoble | France |
| Lille | France |
| Nice | France |
| Paris | France |
| Vandœuvre-lès-Nancy | France |
| Cologne | Germany |
| Düsseldorf | Germany |
| Frankfurt | Germany |
| Freiburg im Breisgau | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Tübingen | Germany |
| Leiden | Netherlands |
| Nijmegen | Netherlands |
| Barcelona | Spain |
| Madrid | Spain |
| Valencia | Spain |
| FG001 | Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
| FG002 | Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| FG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
| Ongoing at Time of Cut-off |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet | Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| BG001 | Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
| BG002 | Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| BG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
| 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 | Percentage of Participants With Virologic Response at Week 12 | Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). | Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Number | Percentage of participants | End of treatment (EOT) (up to Week 48) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). | FAS population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Median | Full Range | Days | Baseline (Day 1) up to EOT (up to Week 48) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Viral Breakthrough at End of Treatment (EOT) | Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL. | FAS population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Number | Participants | EOT (up to Week 48) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Partial Response | Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples). | FAS population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Number | Percentage of participants | Baseline (Day 1) up to EOT (up to Week 48) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12 | Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration. | FAS population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Error | log 10 IU/mL | Baseline (pre-dose), Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT) | Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. | FAS population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Error | log 10 IU/mL | Baseline (pre-dose), EOT (up to Week 48) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24) | SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication. | FAS population included all randomly assigned participants who received at least 1 dose of the study medication. | Posted | Number | Percentage of participants | EOT (up to Week 48) and up to 24 weeks after EOT |
|
Baseline up to end of telaprevir treatment (Week 12)
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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 | Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet | Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. | 5 | 40 | 40 | 40 | ||
| EG001 | Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. | 1 | 42 | 41 | 42 | ||
| EG002 | Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. | 4 | 40 | 39 | 40 | ||
| EG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. | 1 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | 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 |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus ani | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lymphopenia | 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 |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric 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 |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
As per revised Protocol dated 21 Dec 2007, 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 prepublication 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 Titusville, NJ | 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 |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Belgium |
|
| France |
|
| Germany |
|
| Italy |
|
| Netherland |
|
| Spain |
|
| Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet |
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| OG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
|
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
| OG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
|
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
| OG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
|
| Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet |
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| OG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
|
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| OG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
|
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. |
| OG003 | Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule | Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. |
|
|