Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01581203




Registration number
NCT01581203
Ethics application status
Date submitted
18/04/2012
Date registered
20/04/2012
Date last updated
9/10/2015

Titles & IDs
Public title
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
Scientific title
A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Secondary ID [1] 0 0
2011-005446-35
Secondary ID [2] 0 0
AI447-028
Universal Trial Number (UTN)
Trial acronym
Hallmark DUAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus 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
Experimental: Arm 1: Null or Partial Responder to P/R (ASV + DCV) - Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks

Experimental: Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) - Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks

Experimental: Arm 3: Treatment naive (ASV + DCV) - \[Subjects will receive ASV + DCV for 24 weeks\] followed by ASV + DCV for 24 weeks in protocol AI444026\]

Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks

Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks

Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks

Experimental: Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week - Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks

Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks

Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive
Timepoint [1] 0 0
At 12 weeks post-treatment
Secondary outcome [1] 0 0
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R
Timepoint [1] 0 0
Post-treatment Week 12
Secondary outcome [2] 0 0
On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)
Timepoint [2] 0 0
End of Treatment (up to 48 weeks) plus 7 days
Secondary outcome [3] 0 0
Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects
Timepoint [3] 0 0
Up to first 12 weeks
Secondary outcome [4] 0 0
Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort
Timepoint [4] 0 0
Post-treatment Week 12
Secondary outcome [5] 0 0
Proportion of genotype 1b subjects with HCV RNA undetectable
Timepoint [5] 0 0
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort
Secondary outcome [6] 0 0
Proportion of genotypes 1b subjects with HCV RNA < LOQ
Timepoint [6] 0 0
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort
Secondary outcome [7] 0 0
Proportion of subjects with anemia
Timepoint [7] 0 0
At 12 weeks post-treatment
Secondary outcome [8] 0 0
Proportion of subjects with rash
Timepoint [8] 0 0
At 12 weeks post-treatment

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



* Males and females, = 18 years of age
* HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
* HCV RNA = 10,000 IU/mL
* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment of HCV with HCV direct acting antiviral (DAA)
* Evidence of a medical condition contributing to chronic liver disease other than HCV
* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
* Diagnosed or suspected hepatocellular carcinoma or other malignancies
* Uncontrolled diabetes or hypertension

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 assessing the outcomes
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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
748
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 - Kogarah
Recruitment hospital [3] 0 0
Local Institution - Randwick
Recruitment hospital [4] 0 0
Local Institution - Fitzroy
Recruitment hospital [5] 0 0
Local Institution - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Bedford Park, Sa
Recruitment hospital [7] 0 0
Local Institution - Clayton
Recruitment hospital [8] 0 0
Local Institution - Heidelberg
Recruitment hospital [9] 0 0
Local Institution - Melbourne
Recruitment hospital [10] 0 0
Local Institution - Fremantle
Recruitment hospital [11] 0 0
Local Institution - Nedlands
Recruitment hospital [12] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2070 - Randwick
Recruitment postcode(s) [4] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park, Sa
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Salzburg
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
France
State/province [22] 0 0
Clichy Cedex
Country [23] 0 0
France
State/province [23] 0 0
Creteil
Country [24] 0 0
France
State/province [24] 0 0
Lyon Cedex 04
Country [25] 0 0
France
State/province [25] 0 0
Marseille Cedex 08
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 13
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
France
State/province [29] 0 0
Vandoeuvre Les Nancy
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Bonn
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Frankfurt
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Muenchen
Country [37] 0 0
Ireland
State/province [37] 0 0
Dublin
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Tel Aviv
Country [41] 0 0
Israel
State/province [41] 0 0
Tel Hashomer
Country [42] 0 0
Israel
State/province [42] 0 0
Zafed
Country [43] 0 0
Italy
State/province [43] 0 0
Messina
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Italy
State/province [45] 0 0
Roma
Country [46] 0 0
Italy
State/province [46] 0 0
Torino
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Busan
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daegu
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Gyeonggi-do
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Gyeongsangnam-do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Incheon
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seoul
Country [53] 0 0
Netherlands
State/province [53] 0 0
Amsterdam
Country [54] 0 0
Netherlands
State/province [54] 0 0
Leiden
Country [55] 0 0
Netherlands
State/province [55] 0 0
Rotterdam
Country [56] 0 0
New Zealand
State/province [56] 0 0
Auckland
Country [57] 0 0
New Zealand
State/province [57] 0 0
Hamilton
Country [58] 0 0
New Zealand
State/province [58] 0 0
Wellington
Country [59] 0 0
Poland
State/province [59] 0 0
Bialystok
Country [60] 0 0
Poland
State/province [60] 0 0
Wroclaw
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Chelyabinsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Krasnoyarsk
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Moscow
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Saint-Petersburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Samara
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Smolensk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Tyumen
Country [68] 0 0
Spain
State/province [68] 0 0
Alicante
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
Country [71] 0 0
Spain
State/province [71] 0 0
Valencia
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taichung
Country [73] 0 0
Taiwan
State/province [73] 0 0
Tainan
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taipei
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Greater London
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Greater Manchester
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Lanarkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01581203