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The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin) | Experimental | Treatment Naive |
|
| Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin) | Experimental | Treatment Naive |
|
| Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin) | Placebo Comparator | Treatment Naive |
|
| Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin) | Experimental | Non-Responder |
|
| Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin) | Experimental | Non-Responder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Tablets, Oral, 10 mg, daily, 24-48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12. | From Week 4 up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4. | Week 4 |
| Percentage of Participants With a Complete Early Virologic Response (cEVR) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. 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. |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Chiba | Chiba | Japan | |||
| Local Institution |
A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.
The study was conducted at 6 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Daclatasvir | Drug | Tablets, Oral, 60 mg, daily, 24-48 weeks |
|
| Placebo | Drug | Tablets, Oral, 0 mg, daily, 48 weeks |
|
| Peginterferon alfa-2a | Drug | Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks |
|
|
| Ribavirin | Drug | Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks |
|
|
cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12. |
| Week 12 |
| Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24. | Follow up Week 12, Follow up Week 24 |
| From Baseline up to 30 days after last dose of study drug |
| Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN. | From screening up to Week 12 (treatment period) |
| Kurume-Shi |
| Fukuoka |
| 8300011 |
| Japan |
| Local Institution | Okayama | Okayama-ken | 7008558 | Japan |
| Local Institution | Osaka | Osaka | 5438555 | Japan |
| Local Institution | Osaka | Osaka | 545-8586 | Japan |
| Local Institution | Musashino-Shi | Tokyo | 180-0023 | Japan |
| FG001 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| FG002 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| FG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| FG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated participants who received at least 1 dose of study therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. |
| BG001 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| BG002 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| BG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| BG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| BG005 | 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 |
|
| 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 | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4. | All treated participants who received at least 1 dose of study therapy. | Posted | Number | percentage of participants | Week 4 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Complete Early Virologic Response (cEVR) | cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12. | All treated participants who received at least 1 dose of study therapy. | Posted | Number | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24. | All treated participants who received at least 1 dose of study therapy. | Posted | Number | percentage of participants | Follow up Week 12, Follow up Week 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12. | All treated participants who received at least 1 dose of study therapy. | Posted | Number | percentage of participants | From Week 4 up to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. 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 who received at least 1 dose of study therapy. | Posted | Number | participants | From Baseline up to 30 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN. | All treated participants who received at least 1 dose of study therapy. | Posted | Number | Participants | From screening up to Week 12 (treatment period) |
|
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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 | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | 0 | 8 | 8 | 8 | ||
| EG001 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | 2 | 9 | 9 | 9 | ||
| EG002 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | 0 | 8 | 8 | 8 | ||
| EG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | 0 | 8 | 8 | 8 | ||
| EG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | 0 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Heat illness | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Administration site reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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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 | |
|---|---|---|---|---|
| BristolMyers Squibb Study Director | Bristol-Myers Squibb International Corporation | 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
| >=65 years |
|
| Male |
|
| OG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| OG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
|
|
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| OG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| OG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
|
|
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
| OG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| OG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
|
|
| OG002 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| OG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| OG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
|
|
| OG002 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. |
| OG003 | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| OG004 | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
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