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A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02170727
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 16, 2019
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Intervention Drug: DCV/ASV/BMS-791325
Enrollment 199
Recruitment Details  
Pre-assignment Details Total of 169 subjects were treated; 138 treatment-naive and 31 treatment-experienced; 3 participants did not complete the treatment period (1 was lost to follow-up and 2 had withdrawn)
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Period Title: Overall Study
Started 138 31
Completed 135 31
Not Completed 3 0
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             2             0
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced: Total
Hide Arm/Group Description Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 138 31 169
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 31 participants 169 participants
52.0  (11.78) 53.0  (12.64) 52.2  (11.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 31 participants 169 participants
Female
70
  50.7%
11
  35.5%
81
  47.9%
Male
68
  49.3%
20
  64.5%
88
  52.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 31 participants 169 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
128
  92.8%
31
 100.0%
159
  94.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
10
   7.2%
0
   0.0%
10
   5.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 138 participants 31 participants 169 participants
Asia
128
  92.8%
31
 100.0%
159
  94.1%
Europe
10
   7.2%
0
   0.0%
10
   5.9%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Hide Description Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Time Frame Post treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach. (Exact binomial confidence interval reported)
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
98.6
(94.9 to 99.8)
2.Secondary Outcome
Title Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
Hide Description Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).
Time Frame Post treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach.
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(88.8 to 100.0)
3.Secondary Outcome
Title Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Hide Description 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, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
Time Frame On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Week 1
44.2
(35.9 to 52.5)
29.0
(14.2 to 48.0)
Week 2
87.7
(82.2 to 93.2)
80.6
(62.5 to 92.5)
Week 4
99.3
(96.0 to 100.0)
93.5
(78.6 to 99.2)
Week 6
100.0
(97.4 to 100.0)
100.0
(88.8 to 100.0)
Week 8
99.3
(96.0 to 100.0)
100.0
(88.8 to 100.0)
Week 12
100.0
(97.4 to 100.0)
96.8
(83.3 to 99.9)
End of Treatment
100.0
(97.4 to 100.0)
100.0
(88.8 to 100.0)
Follow-Up Week 4
97.8
(93.8 to 99.5)
96.8
(83.3 to 99.9)
Follow-Up Week 8
98.6
(94.9 to 99.8)
96.8
(83.3 to 99.9)
Follow-Up Week 24
96.4
(91.7 to 98.8)
100.0
(88.8 to 100.0)
4.Secondary Outcome
Title Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Hide Description Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
Time Frame On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Week 1
11.6
(6.3 to 16.9)
0.0
(0.0 to 11.2)
Week 2
42.0
(33.8 to 50.3)
25.8
(11.9 to 44.6)
Week 4
93.5
(89.4 to 97.6)
90.3
(74.2 to 98.0)
Week 6
98.6
(94.9 to 99.8)
100.0
(88.8 to 100.0)
Week 8
99.3
(96.0 to 100.0)
100.0
(88.8 to 100.0)
Week 12
97.8
(93.8 to 99.5)
96.8
(83.3 to 99.9)
End of Treatment
97.8
(93.8 to 99.5)
100.0
(88.8 to 100.0)
Follow-Up Week 4
97.1
(92.7 to 99.2)
96.8
(83.3 to 99.9)
Follow-Up Week 8
98.6
(94.9 to 99.8)
96.8
(83.3 to 99.9)
Follow-Up Week 12
98.6
(94.9 to 99.8)
100.0
(88.8 to 100.0)
Follow-Up Week 24
96.4
(91.7 to 98.8)
100.0
(88.8 to 100.0)
5.Secondary Outcome
Title Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Hide Description 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.
Time Frame Up to post treatment week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included participants who received at least 1 dose of study therapy.
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events
2
   1.4%
0
   0.0%
AEs Leading to Discontinuation
2
   1.4%
2
   6.5%
Deaths
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
Hide Description Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
Time Frame Up to post treatment week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included enrolled participants who received at least 1 dose of study therapy
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.4
(0.0 to 3.4)
0.0
(0.0 to 0.0)
7.Secondary Outcome
Title Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Hide Description Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Time Frame Post treatment week 12
Hide Outcome Measure Data
Hide Analysis Population Description
It included enrolled participants who received at least 1 dose of study therapy. Here, N signifies number of participants evaluable for the outcome measure, 'n' signifies number of participants analysed for specific category. SVR12 is based on Next Value Carried Backwards approach
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 136 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Genotype - 1a Number Analyzed 9 participants 2 participants
88.9
(51.8 to 99.7)
100.0
(15.8 to 100.0)
Genotype - 1b Number Analyzed 128 participants 29 participants
100.0
(97.2 to 100.0)
100.0
(88.1 to 100.0)
8.Secondary Outcome
Title Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Hide Description Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Time Frame Post treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Number
Unit of Measure: Percentage of Participants
CC genotype Number Analyzed 98 participants 18 participants
99.0 100.0
Non-CC Genotype Number Analyzed 39 participants 13 participants
97.4 100.0
9.Secondary Outcome
Title Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Hide Description Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Time Frame Post treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach.
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Number
Unit of Measure: Percentage of Participants
Cirrhotic Number Analyzed 16 participants 7 participants
100.0 100.0
Noncirrhotic Number Analyzed 122 participants 24 participants
98.4 100.0
10.Secondary Outcome
Title Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Hide Description Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Time Frame Post treatment week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included participants who received at least 1 dose of study therapy.
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description:
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Overall Number of Participants Analyzed 138 31
Measure Type: Count of Participants
Unit of Measure: Participants
16
  11.6%
5
  16.1%
11.Secondary Outcome
Title Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Hide Description Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Time Frame Up to post treatment week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup analysis set included participants who received at least 1 dose of study therapy.
Arm/Group Title On-Treatment Safety of DCV 3DAA - Cirrhotic On-Treatment Safety - Noncirrhotic
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 146
Measure Type: Count of Participants
Unit of Measure: Participants
Serious AEs
0
   0.0%
2
   1.4%
AEs leading to Discontinuation
1
   4.3%
3
   2.1%
12.Secondary Outcome
Title Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Hide Description Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Time Frame Up to post treatment week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup analysis set included participants who received at least 1 dose of study therapy.
Arm/Group Title On-Treatment Safety of DCV 3DAA - Cirrhotic On-Treatment Safety of DCV 3DAA - Noncirrhotic
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 146
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase
1
   4.3%
6
   4.1%
Aspartate Aminotransferase
1
   4.3%
4
   2.7%
Lipase
2
   8.7%
2
   1.4%
Lymphocytes
0
   0.0%
3
   2.1%
Neutrophils
1
   4.3%
1
   0.7%
Hemoglobin
0
   0.0%
1
   0.7%
Platelets
1
   4.3%
0
   0.0%
International Normalized Ratio
1
   4.3%
0
   0.0%
Serum Glucose
0
   0.0%
1
   0.7%
Time Frame Up to 12 Weeks within 30 days of discontinuation of dosing
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Hide Arm/Group Description Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
All-Cause Mortality
Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/138 (1.45%)      0/31 (0.00%)    
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION † 1  1/138 (0.72%)  1 0/31 (0.00%)  0
Injury, poisoning and procedural complications     
PATELLA FRACTURE † 1  1/138 (0.72%)  1 0/31 (0.00%)  0
Nervous system disorders     
SYNCOPE † 1  1/138 (0.72%)  1 0/31 (0.00%)  0
1
Term from vocabulary, MedDRA Version 18.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment-Naive: DCV/ASV/BMS-791325 Treatment-Experianced:
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/138 (44.93%)      20/31 (64.52%)    
Gastrointestinal disorders     
DIARRHOEA † 1  10/138 (7.25%)  10 2/31 (6.45%)  2
DYSPEPSIA † 1  4/138 (2.90%)  4 2/31 (6.45%)  2
GASTROOESOPHAGEAL REFLUX DISEASE † 1  2/138 (1.45%)  2 2/31 (6.45%)  2
General disorders     
FATIGUE † 1  6/138 (4.35%)  6 4/31 (12.90%)  4
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION † 1  13/138 (9.42%)  14 3/31 (9.68%)  3
Investigations     
ALANINE AMINOTRANSFERASE INCREASED † 1  11/138 (7.97%)  11 4/31 (12.90%)  4
ASPARTATE AMINOTRANSFERASE INCREASED † 1  7/138 (5.07%)  7 2/31 (6.45%)  2
Musculoskeletal and connective tissue disorders     
MYALGIA † 1  9/138 (6.52%)  10 3/31 (9.68%)  3
Nervous system disorders     
HEADACHE † 1  18/138 (13.04%)  19 4/31 (12.90%)  4
DIZZINESS † 1  10/138 (7.25%)  11 1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  7/138 (5.07%)  9 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders     
PRURITUS † 1  7/138 (5.07%)  7 1/31 (3.23%)  1
1
Term from vocabulary, MedDRA Version 18.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02170727    
Other Study ID Numbers: AI443-123
First Submitted: June 20, 2014
First Posted: June 23, 2014
Results First Submitted: March 22, 2019
Results First Posted: August 16, 2019
Last Update Posted: October 29, 2020