Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018295-24 | EudraCT Number |
Not provided
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To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg) | Experimental |
| |
| Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg) | Experimental |
| |
| Placebo plus peg-interferon alfa-2a and ribavirin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as HCV RNA \ | Weeks 4 and 12 |
| Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) | SVR24 was defined as HCV \ | Follow-up Week 24 |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died | SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. | From start of study treatment (day 1) up to follow-up Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable RNA (HCV RNA \ |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Alabama Liver & Digestive Specialists (Alds) | Montgomery | Alabama | 36116 | United States | ||
| Scripps Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25080450 | Derived | Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30. |
Not provided
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A total of 558 participants were enrolled in this study, and 395 participants were randomized and treated.
Participants were enrolled at 64 sites in 11 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Daclatasvir | Drug | Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response |
|
| Placebo | Drug | Tablets, oral, 0 mg, once daily, 24 weeks |
|
| peg-interferon alfa-2a | Drug | Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response |
|
|
| ribavirin | Drug | Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response |
|
|
| Week 4 |
| Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as undetectable RNA (HCV RNA \ | Week 12 |
| Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12) | SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and \ | Follow-up Week 12 |
| Percentage of Resistant Variants Associated With Virologic Failure | Virologic failure was defined as:
| Follow-up Week 48 |
| La Jolla |
| California |
| 92037 |
| United States |
| Cli | Los Angeles | California | 90048 | United States |
| Desta Digestive Disease Medical Center | San Diego | California | 92114 | United States |
| University Of California, San Francisco/Sf General Hospital | San Francisco | California | 94110 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Kaiser Permanente Medical Center | San Francisco | California | 94118 | United States |
| Transplant Center And Hepatology Clinic, B-154 | Aurora | Colorado | 80045 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States |
| University Of Florida Hepatology | Gainesville | Florida | 32610 | United States |
| University Of Miami | Miami | Florida | 33136 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Claudia T. Martorell, Md, Llc | Springfield | Massachusetts | 01105 | United States |
| James Sungsik Park, M.D. C.N.S.C. | Great Neck | New York | 11201 | United States |
| Upper Delaware Valley Infectious Diseases, Pc | Monticello | New York | 12701 | United States |
| James J Peters Vamc | The Bronx | New York | 10468 | United States |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| North Texas Research Institute | Arlington | Texas | 76012 | United States |
| St. Luke'S Episcopal Hospital - Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Westmead Nsw | New South Wales | 2145 | Australia |
| Local Institution | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Clayton Vic | Victoria | 3168 | Australia |
| Local Institution | Camperdown | NSW 2050 | Australia |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local institution | Toronto | Ontario | M5G 2N2 | Canada |
| Local Institution | Toronto | Ontario | M5T 2S8 | Canada |
| Local Institution | Aarhus | 8200 | Denmark |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Odense | 5000 | Denmark |
| Local Institution | Shebin Elkom | Monufia Governorate | 35111 | Egypt |
| Local Institution | Cairo | 11559 | Egypt |
| Local Institution | Créteil | 94000 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Instituition | Paris | 75571 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Düsseldorf | 40237 | Germany |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20099 | Germany |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Pavia | 27100 | Italy |
| Local Institution | Guadalajara | Jalisco | 44340 | Mexico |
| Local Institution | San Juan | 00927 | Puerto Rico |
| Local Institution | Gothenburg | SE-416 85 | Sweden |
| Local Institution | Stockholm | 141 86 | Sweden |
| FG001 | Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. |
| FG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. |
| BG001 | Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. |
| BG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
| BG003 | 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Hepatitis C Virus RNA Distribution | Number | participants |
| ||||||||||||||||
| IL-28B Genotype | 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 Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as HCV RNA \ | All treated participants. Here, 'number of participants' analyzed (N) signifies number of participants evaluable for this outcome measure. | Posted | Number | 80% Confidence Interval | percentage of participants | Weeks 4 and 12 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) | SVR24 was defined as HCV \ | All treated participants. Here, N signifies number of participants evaluable for this outcome measure. | Posted | Number | 80% Confidence Interval | percentage of participants | Follow-up Week 24 |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died | SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. | All treated participants. | Posted | Number | participants | From start of study treatment (day 1) up to follow-up Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable RNA (HCV RNA \ | All treated participants. Here, N signifies number of participants evaluable for this outcome measure. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 4 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as undetectable RNA (HCV RNA \ | All treated participants. Here, N signifies number of participants evaluable for this outcome measure. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12) | SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and \ | All treated participants. Here, N signifies number of participants evaluable for this outcome measure. | Posted | Number | 80% Confidence Interval | percentage of participants | Follow-up Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Resistant Variants Associated With Virologic Failure | Virologic failure was defined as:
| All treated participants. Here, N signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Follow-up Week 48 |
|
From start of study treatment (day 1) up to 7 days post last dose of study treatment (Week 24)
On-treatment period.
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 (20 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 20 mg orally, once daily with pegylated--interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol. | 12 | 159 | 156 | 159 | ||
| EG001 | Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol. | 13 | 158 | 155 | 158 | ||
| EG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. | 6 | 78 | 76 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Auricular perichondritis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Electrocardiogram change | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | 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 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Lost to Follow-up |
|
| Other reasons |
|
| ≥65 years |
|
| Male |
|
| ≥800,000 IU/mL |
|
| CT genotype |
|
| TT genotype |
|
| Missing |
|
| OG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
|
|
| OG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
|
|
| OG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
|
|
| OG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate--interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
|
|
| OG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
|
|
| OG001 | Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. |
| OG002 | Placebo + Peg-interferon Alfa-2a + Ribavirin | Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. |
|
|