Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
Allocation:
Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance
Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice
Number of Arms:
Initial Therapy: 2 Groups
Rescue Therapy: 2 Groups
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: DCV/ASV/BMS-791325+Sofosbuvir | Experimental | Initial Therapy: Daclatasvir/Asunaprevir/BMS-791325 [30 mg (as the free base)/200 mg/75 mg (as the free base)] film coated Fixed Dose Combination tablet twice daily orally for 4 weeks Sofosbuvir 400 mg tablet once daily orally for 4 weeks |
|
| Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir | Experimental | Initial Therapy Daclatasvir/Asunaprevir/BMS-791325 [30 mg (as the free base)/200 mg/75 mg (as the free base)] film coated Fixed Dose Combination tablet twice daily orally for 6 weeks Sofosbuvir 400 mg tablet once daily orally for 6 weeks |
|
| Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a | Experimental | Daclatasvir/Asunaprevir/BMS-791325 [30 mg (as the free base)/200 mg/75 mg (as the free base)] film coated Fixed Dose Combination tablet twice daily orally for 12 weeks Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks With or without Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks |
|
| Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a | Other | Sofosbuvir 400 mg tablet once daily orally for 12 weeks Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV/ASV/BMS-791325 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach. | 12 Weeks after treatment discontinuation (Follow-up Week 12) |
| Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect. | From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months) |
| Number of Participants With Selected Grade 3/4 Laboratory Abnormalities | Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. | From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With End of Treatment Response (EOTR) | EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment. | End of the treatment |
| Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States | ||
| Northwestern Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27943563 | Derived | Sulkowski MS, Flamm S, Kayali Z, Lawitz EJ, Kwo P, McPhee F, Torbeyns A, Hughes EA, Swenson ES, Yin PD, Linaberry M. Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study). Liver Int. 2017 Jun;37(6):836-842. doi: 10.1111/liv.13335. Epub 2017 Feb 2. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
35 participants enrolled in the study, 28 were randomized. Of the 7 not randomized, 1 participant withdrew consent and 6 no longer met study criteria
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 4 Weeks DCV 3DAA + SOF | Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ribavirin | Drug |
|
| Sofosbuvir | Drug |
|
|
| Peginterferon α-2a | Drug |
|
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24). |
| Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24) |
| Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24). | Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24 |
| Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b | Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b | Post-treatment Week 12 |
| Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype) | Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported. | Post-treatment Week 12 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | United States |
| Indiana University Health - University Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University Med Center | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| FG001 | 6 Weeks DCV 3DAA + SOF | Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Follow-up Period |
|
|
All treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 4 Weeks DCV 3DAA + SOF | Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. |
| BG001 | 6 Weeks DCV 3DAA + SOF | Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach. | It included treated participants (randomized participants) who received at least 1 dose of study therapy (DCV 3DAA or SOF). | Posted | Number | 80% Confidence Interval | Percentage of participants | 12 Weeks after treatment discontinuation (Follow-up Week 12) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End of Treatment Response (EOTR) | EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment. | All treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | End of the treatment |
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect. | Safety population included participants who received at least 1 dose of study therapy (DCV 3DAA or SOF). | Posted | Count of Participants | Participants | From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Selected Grade 3/4 Laboratory Abnormalities | Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. | Safety analysis population included participants who received at least 1 dose of study therapy. | Posted | Count of Participants | Participants | From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND | Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24). | It included modified Intent-to-treat treated population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24). | It included modified ITT treated population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b | Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b | All included treated participants. Here n' signifies number of participants analysed for specific category. | Posted | Number | Percentage of Participants | Post-treatment Week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype) | Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported. | All included treated participants. Here, n' signifies number of participants analysed for specific category. | Posted | Number | Percentage of Participants | Post-treatment Week 12 |
|
All AEs were collected from signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 Weeks DCV 3DAA + SOF | Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. | 0 | 14 | 1 | 14 | 5 | 14 |
| EG001 | 6 Weeks DCV 3DAA + SOF | Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. | 0 | 14 | 0 | 14 | 11 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| TOOTH FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| AFFECT LABILITY | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA 17.1 | 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 submitting 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 |
|---|---|
| D012254 | Ribavirin |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|