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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01973049




Registration number
NCT01973049
Ethics application status
Date submitted
25/10/2013
Date registered
31/10/2013
Date last updated
9/10/2015

Titles & IDs
Public title
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
Scientific title
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
Secondary ID [1] 0 0
2013-002458-66
Secondary ID [2] 0 0
AI443-113
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Asunaprevir
Treatment: Drugs - BMS-791325
Treatment: Drugs - Ribavirin
Treatment: Drugs - Placebo matching Ribavirin

Experimental: A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) - Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks
Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks

Experimental: A2: DCV/ASV/BMS-791325 + RBV (naive) - Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks
Ribavirin 200mg tablet orally twice a day for 12 weeks

Experimental: A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) - Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks
Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks

Experimental: A4: DCV/ASV/BMS-791325 + RBV (experienced) - Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks
Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If < 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if = 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening


Treatment: Drugs: Daclatasvir


Treatment: Drugs: Asunaprevir


Treatment: Drugs: BMS-791325


Treatment: Drugs: Ribavirin


Treatment: Drugs: Placebo matching Ribavirin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)
Timepoint [1] 0 0
Post treatment 12 week
Secondary outcome [1] 0 0
Proportion of treated subjects in each of the experienced arms with SVR12
Timepoint [1] 0 0
Post treatment 12 Week
Secondary outcome [2] 0 0
Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND
Timepoint [2] 0 0
Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Secondary outcome [3] 0 0
Proportion of subjects in each arm who achieve HCV RNA < LOQ TND
Timepoint [3] 0 0
Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)
Secondary outcome [4] 0 0
Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)
Timepoint [4] 0 0
Up to end of treatment (week 12) + 7 days
Secondary outcome [5] 0 0
Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg = 10 g/dL at baseline in each arm within each cohort
Timepoint [5] 0 0
Up to end of treatment (week 12) + 7 days
Secondary outcome [6] 0 0
Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities
Timepoint [6] 0 0
Up to end of treatment (week 12) + 7 days
Secondary outcome [7] 0 0
Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b
Timepoint [7] 0 0
Post treatment 12 Week
Secondary outcome [8] 0 0
Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype)
Timepoint [8] 0 0
Post treatment 12 Week

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Subjects chronically infected with HCV genotype 1

- Subjects with compensated cirrhosis

- HCV RNA = 10,000 IU/mL at screening

- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie,
IFNa, pegIFNa), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease,
polymerase inhibitor, etc.)

- Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a
mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir
(ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include,
but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B
(NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects without cirrhosis

- Liver or any other organ transplant

- Current or known history of cancer within 5 years prior to screening

- Documented or suspected hepatocellular carcinoma(HCC)

- Evidence of decompensated liver disease including, but not limited to, radiologic
criteria, a history or presence of ascites, bleeding varices, or hepatic
encephalopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Greenslopes
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Clayton
Recruitment hospital [5] 0 0
Local Institution - Fitzroy
Recruitment hospital [6] 0 0
Local Institution - Heidelberg
Recruitment hospital [7] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Creteil
Country [21] 0 0
France
State/province [21] 0 0
Marseille Cedex 08
Country [22] 0 0
France
State/province [22] 0 0
Montpellier
Country [23] 0 0
France
State/province [23] 0 0
Nice Cedex 03
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 12
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin
in treatment naive cirrhotic subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01973049
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01973049