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Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant (ALLY 1)

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ClinicalTrials.gov Identifier: NCT02032875
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : October 20, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin
Enrollment 116
Recruitment Details The study was conducted at 5 centers in the United States.
Pre-assignment Details A total of 116 participants were enrolled, of which 113 received study treatment (60 cirrhotic cohort, 53: post-liver transplant cohort). Remaining 3 participants no longer met study criteria. Of the 60 participants in the cirrhotic cohort, 57 did not receive a treatment extension and 3 received a treatment extension after liver transplant.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Period Title: Treatment Period
Started 53 60
Completed 52 56
Not Completed 1 4
Reason Not Completed
Adverse Event             1             0
Liver transplant, No extension needed             0             1
Liver transplant, Treatment extension             0             3
Period Title: Follow-up Period
Started 53 [1] 57 [2]
Completed 50 46
Not Completed 3 11
Reason Not Completed
Death             0             1
Virologic Relapse             3             10
[1]
Out of 53 participants who entered the treatment period, all 53 continued in the follow-up period.
[2]
Of 60 participants in treatment period, 57 continued in follow-up, 3 entered treatment extension.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin Total
Hide Arm/Group Description Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. Total of all reporting groups
Overall Number of Baseline Participants 53 60 113
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of active study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 60 participants 113 participants
59.6  (8.25) 57.9  (9.45) 58.7  (8.91)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 60 participants 113 participants
<65 years 42 50 92
>=65 years 11 10 21
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 60 participants 113 participants
Female
15
  28.3%
22
  36.7%
37
  32.7%
Male
38
  71.7%
38
  63.3%
76
  67.3%
Hepatitis C Virus RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 53 participants 60 participants 113 participants
6.61  (0.711) 6.01  (0.617) 6.29  (0.724)
Hepatitis C Virus RNA distribution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 60 participants 113 participants
<800,000 IU/mL 6 27 33
≥800,000 IU/mL 47 33 80
HCV genotype subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 60 participants 113 participants
Hepatitis C Virus genotype 1a 31 34 65
Hepatitis C Virus genotype 1b 10 11 21
Hepatitis C Virus genotype 2 0 5 5
Hepatitis C Virus genotype 3 11 6 17
Hepatitis C Virus genotype 4 0 4 4
Hepatitis C Virus genotype 5 0 0 0
Hepatitis C Virus genotype 6 1 0 1
IL-28B rs1297860 Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 60 participants 113 participants
CC 13 13 26
CT 31 33 64
TT 9 14 23
1.Primary Outcome
Title Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
Hide Description SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame Post-treatment follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.1
(83.5 to 99.4)
2.Primary Outcome
Title Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
Hide Description SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame Post-treatment follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All genotype 1 cirrhotic participants who received at least 1 dose of study therapy.
Arm/Group Title Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
82.2
(67.9 to 92.0)
3.Secondary Outcome
Title Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
Hide Description SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame Post-treatment follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who took at least 1 dose of study medication. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 53 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
All Genotypes (n =53, 60)
94.3
(84.3 to 98.8)
83.3
(71.5 to 91.7)
HCV Genotype 2 (n =0, 5)
NA [1] 
(NA to NA)
80
(28.4 to 99.5)
HCV Genotype 3 (n =11, 6)
90.9
(58.7 to 99.8)
83.3
(35.9 to 99.6)
HCV Genotype 4 (n =0, 4)
NA [1] 
(NA to NA)
100
(39.8 to 100)
HCV Genotype 6 (n =1, 0)
100
(2.5 to 100)
NA [1] 
(NA to NA)
[1]
As none of the participants were evaluable for this reporting arm, the percentage value was not applicable.
4.Secondary Outcome
Title Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Hide Description Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.
Time Frame Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 53 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
22.6
(12.3 to 36.2)
15.0
(7.1 to 26.6)
Week 2
67.9
(53.7 to 80.1)
45.0
(32.1 to 58.4)
Week 4
94.3
(84.3 to 98.8)
95.0
(86.1 to 99.0)
Week 6
96.2
(87.0 to 99.5)
91.7
(81.6 to 97.2)
Week 8
98.1
(89.9 to 100)
95.0
(86.1 to 99.0)
Week 12
98.1
(89.9 to 100)
93.3
(83.8 to 98.2)
End of treatment
100.0
(93.3 to 100.0)
96.7
(88.5 to 99.6)
Follow-up Week 4 (SVR4)
98.1
(89.9 to 100)
88.3
(77.4 to 95.2)
Follow-up Week 8 (SVR8)
96.2
(87 to 99.5)
86.7
(75.4 to 94.1)
Follow-up Week 24 (SVR24)
94.3
(84.3 to 98.8)
80.0
(67.7 to 89.2)
5.Secondary Outcome
Title Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Hide Description Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.
Time Frame Week 1, 2, 4, 6, 8, 12, End of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 53 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
3.8
(0.5 to 13.0)
1.7
(0.0 to 8.9)
Week 2
13.2
(5.5 to 25.3)
11.7
(4.8 to 22.6)
Week 4
56.6
(42.3 to 70.2)
53.3
(40.0 to 66.3)
Week 6
84.9
(72.4 to 93.3)
76.7
(64.0 to 86.6)
Week 8
98.1
(89.9 to 100)
93.3
(83.8 to 98.2)
Week 12
98.1
(89.9 to 100.0)
93.3
(83.8 to 98.2)
End of treatment
100.0
(93.3 to 100.0)
96.7
(88.5 to 99.6)
6.Secondary Outcome
Title Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)
Hide Description Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be <lower limit of quantitation ie, 25 IU/mL or below 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame Post-treatment follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 53 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
CC type (n = 13, 13)
100
(75.3 to 100)
84.6
(54.6 to 98.1)
Non-CC type (n = 40, 47)
92.5
(79.6 to 98.4)
78.7
(64.3 to 89.3)
7.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does 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.
Time Frame From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 53 60
Measure Type: Number
Unit of Measure: participants
SAEs 5 10
AEs leading to discontinuation 6 10
AEs leading to interruption 1 3
Treatment-related AEs 35 37
Treatment-related SAEs 0 0
Adverse events Grade 3 to 4 5 11
Serious adverse events Grade 3 to 4 2 8
Death 0 0
8.Secondary Outcome
Title Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Hide Description Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9-50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1-3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109-0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9-3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4.
Time Frame From start of study treatment up to 7 days post last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description:
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
Overall Number of Participants Analyzed 53 60
Measure Type: Number
Unit of Measure: participants
Hemoglobin 2 5
Platelet count 0 4
International normalized ratio 0 1
Leukocytes 2 0
Lymphocytes (Absolute) 3 6
Alanine aminotransferase 0 2
Aspartate aminotransferase 0 3
Alkaline phosphatase 1 0
Bilirubin (Total) 2 9
Albumin 0 1
Lipase (Total) 2 3
Creatinine 2 2
Time Frame From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Adverse Event Reporting Description Study Start: March 17, 2014; Study Completion: January 5, 2016
 
Arm/Group Title Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Hide Arm/Group Description Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
All-Cause Mortality
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   5/53 (9.43%)   10/60 (16.67%) 
Gastrointestinal disorders     
Haematemesis  1  0/53 (0.00%)  1/60 (1.67%) 
Ascites  1  0/53 (0.00%)  1/60 (1.67%) 
Haemorrhoidal haemorrhage  1  0/53 (0.00%)  1/60 (1.67%) 
Abdominal pain  1  0/53 (0.00%)  1/60 (1.67%) 
Localised intraabdominal fluid collection  1  1/53 (1.89%)  0/60 (0.00%) 
Hepatobiliary disorders     
Hepatic cirrhosis  1  0/53 (0.00%)  1/60 (1.67%) 
Infections and infestations     
Clostridium difficile infection  1  0/53 (0.00%)  1/60 (1.67%) 
Upper respiratory tract infection  1  1/53 (1.89%)  0/60 (0.00%) 
Cellulitis  1  0/53 (0.00%)  1/60 (1.67%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  0/53 (0.00%)  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders     
Polyarthritis  1  1/53 (1.89%)  0/60 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/53 (0.00%)  1/60 (1.67%) 
Hepatocellular carcinoma  1  0/53 (0.00%)  3/60 (5.00%) 
Nervous system disorders     
Encephalopathy  1  0/53 (0.00%)  1/60 (1.67%) 
Hepatic encephalopathy  1  1/53 (1.89%)  1/60 (1.67%) 
Renal and urinary disorders     
Acute kidney injury  1  1/53 (1.89%)  0/60 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   38/53 (71.70%)   42/60 (70.00%) 
Blood and lymphatic system disorders     
Anaemia  1  11/53 (20.75%)  13/60 (21.67%) 
Gastrointestinal disorders     
Diarrhoea  1  10/53 (18.87%)  5/60 (8.33%) 
Abdominal pain  1  3/53 (5.66%)  2/60 (3.33%) 
Nausea  1  3/53 (5.66%)  10/60 (16.67%) 
General disorders     
Fatigue  1  15/53 (28.30%)  11/60 (18.33%) 
Oedema peripheral  1  4/53 (7.55%)  4/60 (6.67%) 
Pyrexia  1  3/53 (5.66%)  3/60 (5.00%) 
Infections and infestations     
Nasopharyngitis  1  3/53 (5.66%)  2/60 (3.33%) 
Upper respiratory tract infection  1  3/53 (5.66%)  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/53 (13.21%)  1/60 (1.67%) 
Back pain  1  1/53 (1.89%)  3/60 (5.00%) 
Nervous system disorders     
Somnolence  1  0/53 (0.00%)  3/60 (5.00%) 
Headache  1  19/53 (35.85%)  9/60 (15.00%) 
Dizziness  1  4/53 (7.55%)  1/60 (1.67%) 
Psychiatric disorders     
Insomnia  1  4/53 (7.55%)  3/60 (5.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/53 (1.89%)  5/60 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032875    
Other Study ID Numbers: AI444-215
First Submitted: January 9, 2014
First Posted: January 10, 2014
Results First Submitted: August 18, 2015
Results First Posted: October 20, 2015
Last Update Posted: February 9, 2017