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The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin) | Experimental | Treatment Naive |
|
| Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin) | Experimental | Treatment Naive |
|
| Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin) | Placebo Comparator | Treatment Naive |
|
| Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin) | Experimental | Non-Responder |
|
| Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin) | Experimental | Non-Responder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-790052 | 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, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory. | At Weeks 4 and 12 on treatment |
| 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, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory . | At Week 4 on treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. |
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 | Hiroshima | Hiroshima | 734-0037 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24468783 | Derived | Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27. |
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A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.
The study was conducted at 6 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + pegIFNα + Ribavirin (Treatment-naive) | Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| End of Treatment Period |
|
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| BMS-790052 | Drug | Tablets, Oral, 60 mg, daily, 24-48 weeks |
|
| Placebo | Drug | Tablets, Oral, 0 mg, daily, 48 weeks |
|
| Peginterferon alfa-2b | Drug | Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks |
|
|
| Ribavirin | Drug | Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks |
|
|
| Percentage of Participants With Complete Early Virologic Response (cEVR) |
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory |
| At Week 12 on treatment |
| Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory . | Follow-up Weeks 4, 12, and 24 |
| Percentage of Participants With Virologic Failure | Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment. | From on-treatment Week 1 to Follow-up Week 24 |
| From baseline to 30 days after last dose of study drug |
| Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN. | From baseline to 30 days after last dose of study drug |
| Sapporo |
| Hokkaido |
| 060-0033 |
| Japan |
| Local Institution | Kawasaki-Shi | Kanagawa | 2138587 | Japan |
| Local Institution | Suita-Shi | Osaka | 5650871 | Japan |
| Local Institution | Iruma-Gun | Saitama | 3500495 | Japan |
| Local Institution | Minato-Ku | Tokyo | 105-0001 | Japan |
| FG001 | Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| FG002 | Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| FG003 | Daclatasvir 10- mg + pegIFNα+ Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| FG004 | Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
All treated participants who received at least 1 dose of study therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + pegIFNα + Ribavirin (Treatment-naive) | Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| BG001 | Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| BG002 | Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| BG003 | Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| BG004 | Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. | All participants who received at least 1 dose of study therapy. | Posted | Number | participants | From baseline to 30 days after last dose of study drug |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN. | All participants who received at least 1 dose of study therapy. | Posted | Number | participants | From baseline to 30 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| 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, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory. | All participants who received at least 1 dose of study therapy. | Posted | Number | 80% Confidence Interval | percentage of participants | At Weeks 4 and 12 on treatment |
| |||||||||||||||||||||||||||||||||||||||
| 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, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory . | All participants who received at least 1 dose of study therapy. | Posted | Number | 80% Confidence Interval | percentage of participants | At Week 4 on treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory | All participants who received at least 1 dose of study therapy. | Posted | Number | 80% Confidence Interval | percentage of participants | At Week 12 on treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory . | All participants who received at least 1 dose of study therapy. | Posted | Number | 80% Confidence Interval | percentage of participants | Follow-up Weeks 4, 12, and 24 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment. | All participants who received at least 1 dose of study therapy. | Posted | Number | percentage of participants | From on-treatment Week 1 to Follow-up Week 24 |
|
From baseline up to 30 days after last dose of study drug
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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 +Ribavirin (Treatment Naive) | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) 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 IFNα containing regimens including pegIFNα-2b/ribavirin. | 0 | 8 | 8 | 8 | ||
| EG001 | Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive) | Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin. | 0 | 9 | 9 | 9 | ||
| EG002 | Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive) | Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα 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 IFNα containing regimens including pegIFNα-2b/ribavirin. | 0 | 10 | 10 | 10 | ||
| EG003 | Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders) | Participants received 10 mg of daclatasvir OD coadministered with pegIFNα 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-2b/ribavirin. | 1 | 9 | 9 | 9 | ||
| EG004 | Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders) | Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα 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-2b/ribavirin. | 0 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retinal disorder | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Inner ear disorder | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Phosphenes | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vessel puncture site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site injury | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vessel puncture site pruritus | General disorders | MedDRA 14.0 | 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 | |
|---|---|---|---|---|
| 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 |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Discontinuation due to AEs |
|
| Treatment-related AEs |
|
| Death |
|
| OG002 | Daclatasvir 60- mg + pegIFNα- + Ribavirin (Treatment-naive) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| OG003 | Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| OG004 | Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
|
|
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| OG003 | Daclatasvir 10- mg + pegINFα + Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| OG004 | Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. |
|
|
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| OG003 | Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.. |
| OG004 | Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. |
|
|
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| OG003 | Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| OG004 | Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. |
|
|
| OG002 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) |
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| OG003 | Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| OG004 | Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin |
|
|
| OG002 | Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive) | received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. |
| OG003 | Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. |
| OG004 | Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. |
|
|