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A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks | Experimental | Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks |
|
| Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks | Experimental | Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks |
|
| Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks | Experimental | Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA \ | At follow-up Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA\ |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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 |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Pacific Oaks Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27025835 | Derived | Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016 Jun 15;62(12):1489-96. doi: 10.1093/cid/ciw163. Epub 2016 Mar 29. | |
| 26196502 |
Not provided
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A total of 238 participants were enrolled, and 203 received treatment. Of the 35 participants who were enrolled but did not receive treatment, 2 withdrew consent, 31 no longer met study criteria, 1 was lost to follow-up, and 1 was eliminated for other reasons.
The study was conducted at 37 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up. |
| FG001 | Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
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Not provided
Not provided
| Sofosbuvir | Drug |
|
| At follow-up Week 12 |
| Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA \ | At follow-up Week 12 |
| Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA levels \ | At follow-up Week 12 |
| Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Participants with hepatitis C virus CV) levels to be \ | Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24 |
| Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Participants with HCV RNA levels \ | At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment |
| Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR is defined as hepatitis C virus RNA \ | At Follow-up Week 12 |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. | AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks) |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. | AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period. |
| Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. | From screening up to week 24 of post treatment follow--up |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Va Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Peter J Ruane Md Inc | Los Angeles | California | 90036 | United States |
| Anthony M. Mills Md Inc | Los Angeles | California | 90069 | United States |
| Jeffrey Goodman Special Care Clinic | Los Angeles | California | 90232 | United States |
| Ucsd Antiviral Research Center (Avrc) | San Diego | California | 92103 | United States |
| Precision Research Institute, Llc | San Diego | California | 92114 | United States |
| University Of California San Francisco | San Francisco | California | 94110 | United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Whitman Walker Health | Washington D.C. | District of Columbia | 20009 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Capital Medical Associates | Washington D.C. | District of Columbia | 20036 | United States |
| Midway Immunology And Research Center | Ft. Pierce | Florida | 34982 | United States |
| University Of Miami Schiff Center For Liver Diseases | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Infect. Disease Specialists | Decatur | Georgia | 30033 | United States |
| Indiana University Health - University Hospital | Indianapolis | Indiana | 46202 | United States |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Southwest Care Center | Sante Fe | New Mexico | 87505 | United States |
| Binghamton Gastroenterology Associates | Binghamton | New York | 13903 | United States |
| Icahn School Of Medicine At Mount Sinai | New York | New York | 10029 | United States |
| University Of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| Oregon Health Science Univ | Portland | Oregon | 97239 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18102 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Tarrant County Inf Dis Assoc | Fort Worth | Texas | 76104 | United States |
| Cure C Consortium | Houston | Texas | 77004 | United States |
| University Of Texas Health Science Center At Houston | Houston | Texas | 77030 | United States |
| Clinical Research Centers Of America | Murray | Utah | 84123 | United States |
| Mcguire D V A M C | Richmond | Virginia | 23249 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21. |
Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up. |
| FG002 | Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
All participants who received at least 1 dose of active study therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. |
| BG001 | Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up. |
| BG002 | Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Hepatitis C Virus RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| Hepatitis C Virus RNA distribution | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA \ | All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At follow-up Week 12 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA\ | All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At follow-up Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA \ | All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At follow-up Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) | SVR12 was defined as HCV RNA levels \ | All participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At follow-up Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Participants with hepatitis C virus CV) levels to be \ | All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Participants with HCV RNA levels \ | All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR is defined as hepatitis C virus RNA \ | All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Follow-up Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. | All participants who received at least 1 dose of study drug. | Posted | Number | Participants | AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period. |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | From screening up to week 24 of post treatment follow--up |
|
AEs: From first dose of study drug to 7 days after last dose. SAEs: From baseline to 30 days after last dose of study drug
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 | Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up. | 1 | 101 | 51 | 101 | ||
| EG001 | Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up. | 0 | 50 | 14 | 50 | ||
| EG002 | Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up. | 3 | 52 | 25 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug abuse | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue 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 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 |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided
| Other |
|
| >=65 years |
|
| Male |
|
| ≥800,000 IU/mL |
|
|
|
Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
|
|
|
|
|
|
|
|
| OG002 | Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up. |
|
|
| OG002 | Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up. |
|
|
Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up. |
|
|