Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000070-28 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir | Experimental | Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal for 12 weeks |
|
| Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin | Experimental | Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing <75 kg received a total ribavirin dose of 1000 mg per day; those weighing >=75 kg received 1200 mg per day) for 12 weeks. |
|
| Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin | Experimental | Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing <75 kg received a total ribavirin dose of 1000 mg per day; those weighing >=75 kg received 1200 mg per day) for 12 weeks. |
|
| Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin | Experimental | Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing <75 kg received a total ribavirin dose of 1000 mg per day; those weighing >=75 kg received 1200 mg per day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Tablets, oral, 30 mg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12) | SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \ | Post Treatment Week 12 (Follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as hepatitis C virus (HCV) RNA levels to be \ | Week 4 |
Not provided
Key Inclusion Criteria:
Hepatitis C virus (HCV) genotype 1a or 1b
Males and females, ≥18 years of age
HCV RNA ≥10,000 IU/mL
Participants with compensated cirrhosis are permitted
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States | ||
| Kaiser Permanente Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26453968 | Derived | Zeuzem S, Hezode C, Bronowicki JP, Loustaud-Ratti V, Gea F, Buti M, Olveira A, Banyai T, Al-Assi MT, Petersen J, Thabut D, Gadano A, Pruitt R, Makara M, Bourliere M, Pol S, Beumont-Mauviel M, Ouwerkerk-Mahadevan S, Picchio G, Bifano M, McPhee F, Boparai N, Cheung K, Hughes EA, Noviello S; LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J Hepatol. 2016 Feb;64(2):292-300. doi: 10.1016/j.jhep.2015.09.024. Epub 2015 Oct 8. |
Not provided
Not provided
Of the 230 participants enrolled, 168 received treatment.
The study was conducted at 25 centers in 6 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Genotype 1b: Daclatasvir + Simeprevir (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Simeprevir | Drug | Capsule, oral, 150 mg, once daily |
|
|
| Ribavirin | Drug | Tablets, oral, 500-600 mg, twice daily |
|
| Percentage of Participants With Complete Early Virologic Response (cEVR) |
cEVR was defined as hepatitis C virus (HCV) RNA levels to be \ |
| Week 12 |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR were defined as hepatitis C virus (HCV) RNA levels to be \ | Week 4 and Week 12 |
| Percentage of Participants With End of Treatment Response (EOTR) | EOTR were defined as hepatitis C virus (HCV) RNA levels \ | End of treatment (Week 24) |
| Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories | Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | Baseline, post-treatment Week 12 (Follow-up period) |
| Number of Participants With Serious Adverse Events (SAEs) and 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 necessarily have 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. | From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24) |
| San Francisco |
| California |
| 94118 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Texas Clinical Research Institute, Llc | Arlington | Texas | 76012 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1119 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Limoges | 87042 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pessac | 33600 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Berlin | 10969 | Germany |
| Local Institution | Cologne | 50937 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20099 | Germany |
| Local Institution | Budapest | 1097 | Hungary |
| Local Institution | Budapest | 1126 | Hungary |
| Local Institution | Gyula | 5700 | Hungary |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| FG001 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) |
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| FG002 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| FG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period. |
| FG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| FG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis was performed on the treated participants defined as all randomized participants who received at least 1 dose of active study therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genotype 1b: Daclatasvir + Simeprevir (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period. |
| BG001 | Genotype 1b: Daclatasvir + Simeprevir (Null) | Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| BG002 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| BG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period. |
| BG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| BG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| BG006 | 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 |
| ||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Hepatitis C Virus RNA Distribution | Number | participants |
| ||||||||||||||||
| Randomization Stratum | 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 | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as hepatitis C virus (HCV) RNA levels to be \ | All treated participants. | Posted | Number | 80% Confidence Interval | Percentage of participants | Week 4 |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as hepatitis C virus (HCV) RNA levels to be \ | All treated participants. | Posted | Number | 80% Confidence Interval | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12) | SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \ | All participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin). | Posted | Number | 80% Confidence Interval | Percentage of participants | Post Treatment Week 12 (Follow-up period) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR were defined as hepatitis C virus (HCV) RNA levels to be \ | All treated participants. | Posted | Number | 80% Confidence Interval | Percentage of participants | Week 4 and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End of Treatment Response (EOTR) | EOTR were defined as hepatitis C virus (HCV) RNA levels \ | All treated participants. | Posted | Number | 80% Confidence Interval | Percentage of participants | End of treatment (Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories | Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | All treated participants. Here 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Number | Percentage of participants | Baseline, post-treatment Week 12 (Follow-up period) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and 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 necessarily have 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. | All treated participants. | Posted | Number | Participants | From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24) |
|
From start of 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 | Genotype 1b: Daclatasvir + Simeprevir (Naive + Null) | Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period. | 7 | 76 | 49 | 76 | ||
| EG001 | Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null) | Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. | 3 | 71 | 63 | 71 | ||
| EG002 | Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null) | Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. | 1 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial haematoma | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | 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 |
| D000069616 | Simeprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| 21-<65 years |
|
| >=65 years |
|
| Male |
|
| ≥800,000 IU/mL |
|
| Hepatitis C Virus Genotype 1a |
|
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| OG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
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| OG002 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| OG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
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Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period. |
| OG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| OG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
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Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period. |
| OG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| OG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
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| OG002 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up. |
| OG003 | Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period. |
| OG004 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
| OG005 | Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
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Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
| OG002 | Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null) | Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks. |
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