Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (FOURward)

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: NCT02175966
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : May 29, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: DCV/ASV/BMS-791325
Drug: Ribavirin
Drug: Sofosbuvir
Drug: Peginterferon α-2a
Enrollment 35
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description 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. 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.
Period Title: Treatment Period
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Follow-up Period
Started 14 14
Completed 4 8
Not Completed 10 6
Reason Not Completed
Lack of Efficacy             10             6
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
All treated participants.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
58.0
(21 to 64)
59.0
(31 to 64)
58.5
(21 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
9
  64.3%
8
  57.1%
17
  60.7%
Male
5
  35.7%
6
  42.9%
11
  39.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   7.1%
0
   0.0%
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.1%
1
   7.1%
2
   7.1%
White
12
  85.7%
13
  92.9%
25
  89.3%
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%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 (SVR12)
Hide Description 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.
Time Frame 12 Weeks after treatment discontinuation (Follow-up Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
It included treated participants (randomized participants) who received at least 1 dose of study therapy (DCV 3DAA or SOF).
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentage of participants
28.6
(13.1 to 49.2)
57.1
(36.9 to 75.7)
2.Primary 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 From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study therapy (DCV 3DAA or SOF).
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
Death
0
   0.0%
0
   0.0%
Serious Adverse Events
1
   7.1%
0
   0.0%
AEs Leading to Discontinuation
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Hide Description 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.
Time Frame From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
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 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Percentage of Participants With End of Treatment Response (EOTR)
Hide Description EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.
Time Frame End of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
92.9
(66.1 to 99.8)
100.0
(76.8 to 100.0)
5.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, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).
Time Frame Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)
Hide Outcome Measure Data
Hide Analysis Population Description
It included modified Intent-to-treat treated population.
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Week 1
35.7
(12.8 to 64.9)
71.4
(41.9 to 91.6)
Week 2
78.6
(49.2 to 95.3)
100.0
(76.8 to 100.0)
Week 4
100.0
(76.8 to 100.0)
100.0
(76.8 to 100.0)
Week 6
NA [1] 
(NA to NA)
100.0
(76.8 to 100.0)
Follow-Up Week 2
78.6
(49.2 to 95.3)
100.0
(76.8 to 100.0)
Follow-Up Week 4
42.9
(17.7 to 71.1)
78.6
(49.2 to 95.3)
Follow-Up Week 12
28.6
(8.4 to 58.1)
57.1
(28.9 to 82.3)
Follow-Up Week 24
28.6
(8.4 to 58.1)
57.1
(28.9 to 82.3)
[1]
NA signifies data was not estimable due to lesser number of events.
6.Secondary Outcome
Title Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Hide Description 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).
Time Frame Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
It included modified ITT treated population.
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
21.4
(4.7 to 50.8)
7.1
(0.2 to 33.9)
Week 2
42.9
(17.7 to 71.1)
64.3
(35.1 to 87.2)
Week 4
92.9
(66.1 to 99.8)
100.0
(76.8 to 100.0)
Week 6
NA [1] 
(NA to NA)
100.0
(76.8 to 100.0)
Follow-Up Week 2
71.4
(41.9 to 91.6)
92.9
(66.1 to 99.8)
Follow-Up Week 4
42.9
(17.7 to 71.1)
71.4
(41.9 to 91.6)
Follow-Up Week 12
28.6
(8.4 to 58.1)
57.1
(28.9 to 82.3)
Follow-Up Week 24
28.6
(8.4 to 58.1)
57.1
(28.9 to 82.3)
[1]
NA signifies data was not reported due to lesser number of events.
7.Secondary Outcome
Title Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
Hide Description Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b
Time Frame Post-treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All included treated participants. Here n' signifies number of participants analysed for specific category.
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: Percentage of Participants
Genotype 1a Number Analyzed 11 participants 11 participants
27.3 54.5
Genotype 1b Number Analyzed 3 participants 3 participants
33.3 66.7
8.Secondary Outcome
Title Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)
Hide Description Percentage 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
All included treated participants. Here, n' signifies number of participants analysed for specific category.
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: Percentage of Participants
CC genotype Number Analyzed 5 participants 6 participants
40.0 66.7
Non-CC Genotype Number Analyzed 9 participants 8 participants
22.2 50.0
Time Frame All AEs were collected from signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Hide Arm/Group Description 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. 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.
All-Cause Mortality
4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Hide Serious Adverse Events
4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   0/14 (0.00%) 
Injury, poisoning and procedural complications     
Overdose † 1  1/14 (7.14%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
4 Weeks DCV 3DAA + SOF 6 Weeks DCV 3DAA + SOF
Affected / at Risk (%) Affected / at Risk (%)
Total   5/14 (35.71%)   11/14 (78.57%) 
Ear and labyrinth disorders     
VERTIGO † 1  1/14 (7.14%)  1/14 (7.14%) 
Gastrointestinal disorders     
NAUSEA † 1  2/14 (14.29%)  1/14 (7.14%) 
DIARRHOEA † 1  1/14 (7.14%)  1/14 (7.14%) 
CONSTIPATION † 1  0/14 (0.00%)  1/14 (7.14%) 
DRY MOUTH † 1  1/14 (7.14%)  0/14 (0.00%) 
DYSPEPSIA † 1  0/14 (0.00%)  1/14 (7.14%) 
FLATULENCE † 1  1/14 (7.14%)  0/14 (0.00%) 
TOOTHACHE † 1  0/14 (0.00%)  1/14 (7.14%) 
General disorders     
FATIGUE † 1  3/14 (21.43%)  4/14 (28.57%) 
CHEST DISCOMFORT † 1  0/14 (0.00%)  1/14 (7.14%) 
CHILLS † 1  1/14 (7.14%)  0/14 (0.00%) 
OEDEMA PERIPHERAL † 1  1/14 (7.14%)  0/14 (0.00%) 
PYREXIA † 1  1/14 (7.14%)  0/14 (0.00%) 
Infections and infestations     
URINARY TRACT INFECTION † 1  1/14 (7.14%)  1/14 (7.14%) 
ORAL HERPES † 1  0/14 (0.00%)  1/14 (7.14%) 
SINUSITIS † 1  1/14 (7.14%)  0/14 (0.00%) 
Injury, poisoning and procedural complications     
TOOTH FRACTURE † 1  0/14 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  0/14 (0.00%)  1/14 (7.14%) 
INTERVERTEBRAL DISC PROTRUSION † 1  0/14 (0.00%)  1/14 (7.14%) 
MUSCULOSKELETAL PAIN † 1  0/14 (0.00%)  1/14 (7.14%) 
PAIN IN EXTREMITY † 1  0/14 (0.00%)  1/14 (7.14%) 
Nervous system disorders     
HEADACHE † 1  2/14 (14.29%)  3/14 (21.43%) 
DIZZINESS † 1  1/14 (7.14%)  1/14 (7.14%) 
Psychiatric disorders     
INSOMNIA † 1  0/14 (0.00%)  2/14 (14.29%) 
AFFECT LABILITY † 1  0/14 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
OROPHARYNGEAL PAIN † 1  1/14 (7.14%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders     
RASH † 1  1/14 (7.14%)  0/14 (0.00%) 
RASH PRURITIC † 1  0/14 (0.00%)  1/14 (7.14%) 
Vascular disorders     
FLUSHING † 1  0/14 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA 17.1
†
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 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.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02175966    
Other Study ID Numbers: AI443-131
First Submitted: June 25, 2014
First Posted: June 26, 2014
Results First Submitted: March 22, 2019
Results First Posted: May 29, 2019
Last Update Posted: August 11, 2020