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:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
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and 31 treatment-experienced; 3 participants did not complete the treatment period (1 was lost to follow-up and 2 had withdrawn) |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: |
---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Treatment-Naive: DCV/ASV/BMS-791325 | Treatment-Experianced: | Total | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Bristol-Myers Squibb Study Director |
Organization: | Bristol-Myers Squibb |
EMail: | Clinical.Trials@bms.com |
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 |