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Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

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ClinicalTrials.gov Identifier: NCT02032901
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : September 14, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 9, 2014
First Posted Date  ICMJE January 10, 2014
Results First Submitted Date  ICMJE August 12, 2015
Results First Posted Date  ICMJE September 14, 2015
Last Update Posted Date October 1, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
  • Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • Proportion of treatment naive subjects with sustained virologic response 12 (SVR12) [ Time Frame: Post treatment Week 12 ]
    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12
  • Proportion of treatment experienced subjects with SVR12 [ Time Frame: Post treatment Week 12 ]
Change History Complete list of historical versions of study NCT02032901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
  • Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) [ Time Frame: Week 4 ]
    RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) [ Time Frame: Week 12 ]
    cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) [ Time Frame: Up to the end of treatment (up to 24 weeks) ]
    EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) [ Time Frame: Week 1, 2, 6, 8 (treatment period) ]
    Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND) [ Time Frame: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period) ]
    Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) [ Time Frame: Baseline, Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
  • Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12) [ Time Frame: Week 12 (Follow-up period) ]
    Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
  • Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) [ Time Frame: From Day 1 first dose to last dose plus 7 days ]
    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • Safety measured by frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 laboratory abnormalities [ Time Frame: Up to end of treatment (EOT) (Week 12) + 7 days ]
  • The proportion of subjects who achieve HCV RNA < LLOQ-TD/TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12; EOT; post-treatment Weeks 4 and 24 ]
  • The proportion of subjects who achieve HCV RNA < LLOQ TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12; EOT ]
  • The proportion of subjects who achieve SVR12 by baseline cirrhosis (presence or absence) [ Time Frame: Post treatment Week 12 ]
  • The proportion of subjects with CC or non-CC genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNPs) who achieve SVR12 [ Time Frame: Post treatment Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Official Title  ICMJE A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
Brief Summary To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Daclatasvir
    Other Name: BMS-790052
  • Drug: Sofosbuvir
Study Arms  ICMJE
  • Experimental: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
    Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
    Interventions:
    • Drug: Daclatasvir
    • Drug: Sofosbuvir
  • Experimental: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
    Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
    Interventions:
    • Drug: Daclatasvir
    • Drug: Sofosbuvir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2015)
173
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2014)
150
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with hepatitis C virus (HCV) genotype 3
  • Subjects who are HCV treatment-naive
  • Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
  • HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

  • HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032901
Other Study ID Numbers  ICMJE AI444-218
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP