Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004237-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients
Allocation: Randomized Stratified
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir + Peginterferon alfa-2a + Ribavirin | Experimental |
| |
| Telaprevir + Peginterferon alfa-2a + Ribavirin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Film-coated tablet, oral, 60 mg, once daily, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12. | Week 12 (Follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment. | Week 4 |
| Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona |
Of the 793 participants, 605 were randomized to treatment. A total of 191 enrolled subjects did not enter the treatment period as they no longer met study entry criteria and a 602 participants were received treatment.
A total of 793 participants were recruited at 90 sites in 15 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir + PEG-IFN Alpha-2a + Ribavirin | Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telaprevir | Drug | Film-coated tablet, oral, 750 mg, 3 times daily |
|
|
| Peginterferon alfa-2a | Drug | Solution for injection, subcutaneous injection, 180 μg, weekly |
|
|
| Ribavirin | Drug | Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day |
|
|
eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment. |
| Week 4, Week 12 |
| Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment. | Week 12 |
| Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24) | SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment. | Week 24 (Follow-up period) |
| Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment. | Week 12 (Follow-up period) |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Va Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520-8019 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Atlanta Medical Center | Atlanta | Georgia | 30312 | United States |
| Gastrointestinal Specialists Of Georgia | Marietta | Georgia | 30060 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University Of Maryland | Baltimore | Maryland | 21201-1595 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota | 55114 | United States |
| Saint Louis University Gastroenterology & Hepatology | St Louis | Missouri | 63104 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599-7584 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Research Specialists Of Texas | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Prov. Buenos Aires | Buenos Aires | 1629 | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Camperdown | New South Wales | 2050 | Australia |
| Local Institution | Penrith | New South Wales | 2750 | Australia |
| Local Institution | Westmead Nsw | New South Wales | 2145 | Australia |
| Local Institution | Greenslopes Qld | Queensland | 4120 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 VIC | Australia |
| Local Institution | Prahran | Victoria | 3181 | Australia |
| Local Institution | Linz | 4010 | Austria |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Vienna | 1160 | Austria |
| Local Institution | São Paulo | São Paulo | 04023-062 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Toronto | Ontario | M5G 2N2 | Canada |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Odense | 5000 | Denmark |
| Local Institution | Besançon | 25000 | France |
| Local Institution | Bondy | 93143 | France |
| Local Institution | Grenoble | 38043 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Pessac | 33600 | France |
| Local Institution | Strasbourg | 67090 | France |
| Local Institution | Berlin | 10969 | Germany |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Cologne | 50937 | Germany |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Haifa | 31096 | Israel |
| Local Institution | Nazareth | 16100 | Israel |
| Local Institution | Safed | 13110 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Local Institution | Bergamo | 24127 | Italy |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Florence | 50134 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Torino | 10100 | Italy |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Chorzów | 41-500 | Poland |
| Local Institution | Kielce | 25-317 | Poland |
| Local Institution | Mysłowice | 41-400 | Poland |
| Local Institution | Racibórz | 47-400 | Poland |
| Local Institution | Wroclaw | 50-220 | Poland |
| Local Institution | Moscow | 109240 | Russia |
| Local Institution | Moscow | 119991 | Russia |
| Local Institution | Moscow | 121170 | Russia |
| Local Institution | Alcorcón | 28922 | Spain |
| Local Institution | Barcelona | 08003 | Spain |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| Local Institution | Zurich | 8091 | Switzerland |
| Local Institution | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Local Institution | Glasgow | Scotland | G12 0YN | United Kingdom |
| Local Institution | Birmingham | West Midlands | B15 2TH | United Kingdom |
| FG001 | Telaprevir + PEG-IFN Alpha-2a + Ribavirin | Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir + PEG-IFN Alpha-2a + Ribavirin | Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day). |
| BG001 | Telaprevir + PEG-IFN Alpha-2a + Ribavirin | Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (Follow-up period) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12 | eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24) | SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 (Follow-up period) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (Follow-up period) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daclatasvir + PEG-IFN Alpha-2a + Ribavirin | Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) | 26 | 402 | 384 | 402 | ||
| EG001 | Telaprevir + PEG-IFN Alpha-2a + Ribavirin | Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food | 20 | 200 | 193 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Proctitis infectious | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C486464 | telaprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Other |
|
| Participant Withdrew Consent |
|
| Lost to Follow-up |
|
| 65 years and older |
|
| Male |
|
| Yes |
| Non-Inferiority or Equivalence |
Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI > -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm. |
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