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Trial record 78 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

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ClinicalTrials.gov Identifier: NCT01017575
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C Infection
Interventions Drug: Daclatasvir
Drug: Placebo
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 55
Recruitment Details The study was conducted at 6 sites in Japan.
Pre-assignment Details A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin. Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin. Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin. Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Period Title: Overall Study
Started 8 9 8 8 9
Completed 7 7 8 7 6
Not Completed 1 2 0 1 3
Reason Not Completed
Lack of Efficacy             0             1             0             1             1
Adverse Event             0             1             0             0             2
Withdrawal by Subject             1             0             0             0             0
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) Total
Hide Arm/Group Description Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin. Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin. Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin. Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. Total of all reporting groups
Overall Number of Baseline Participants 8 9 8 8 9 42
Hide Baseline Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 8 participants 8 participants 9 participants 42 participants
<65 years 7 8 6 6 8 35
>=65 years 1 1 2 2 1 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 8 participants 8 participants 9 participants 42 participants
Female
5
  62.5%
5
  55.6%
6
  75.0%
2
  25.0%
4
  44.4%
22
  52.4%
Male
3
  37.5%
4
  44.4%
2
  25.0%
6
  75.0%
5
  55.6%
20
  47.6%
1.Primary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Time Frame From Week 4 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Overall Number of Participants Analyzed 8 9 8 8 9
Measure Type: Number
Unit of Measure: percentage of participants
12.5 66.7 62.5 62.5 77.8
2.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR)
Hide Description RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Overall Number of Participants Analyzed 8 9 8 8 9
Measure Type: Number
Unit of Measure: percentage of participants
12.5 77.8 62.5 62.5 88.9
3.Secondary Outcome
Title Percentage of Participants With a Complete Early Virologic Response (cEVR)
Hide Description cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Overall Number of Participants Analyzed 8 9 8 8 9
Measure Type: Number
Unit of Measure: percentage of participants
62.5 88.9 100 87.5 88.9
4.Secondary Outcome
Title Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
Hide Description SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.
Time Frame Follow up Week 12, Follow up Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Overall Number of Participants Analyzed 8 9 8 8 9
Measure Type: Number
Unit of Measure: percentage of participants
SVR12 75 88.9 100 50 77.8
SVR24 75 88.9 100 50 77.8
5.Other Pre-specified Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has 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.
Time Frame From Baseline up to 30 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Overall Number of Participants Analyzed 8 9 8 8 9
Measure Type: Number
Unit of Measure: participants
SAEs 0 2 0 0 0
Discontinuations due to AEs 0 1 0 0 2
Death 0 0 0 0 0
6.Other Pre-specified Outcome
Title Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Hide Description Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.
Time Frame From screening up to Week 12 (treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Overall Number of Participants Analyzed 8 9 8 8 9
Measure Type: Number
Unit of Measure: Participants
Hemoglobin 0 2 1 0 2
Lymphocytes 5 2 4 5 3
Neutrophils 4 4 3 3 2
Platelets 0 0 0 2 0
WBC 3 1 2 2 2
AST 0 0 0 1 0
Lipase 0 1 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Hide Arm/Group Description Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
All-Cause Mortality
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   2/9 (22.22%)   0/8 (0.00%)   0/8 (0.00%)   0/9 (0.00%) 
Gastrointestinal disorders           
Pancreatitis acute  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   9/9 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   9/9 (100.00%) 
Blood and lymphatic system disorders           
Anaemia  1  5/8 (62.50%)  6/9 (66.67%)  5/8 (62.50%)  4/8 (50.00%)  5/9 (55.56%) 
Leukopenia  1  3/8 (37.50%)  1/9 (11.11%)  2/8 (25.00%)  2/8 (25.00%)  2/9 (22.22%) 
Lymphopenia  1  5/8 (62.50%)  2/9 (22.22%)  4/8 (50.00%)  5/8 (62.50%)  3/9 (33.33%) 
Thrombocytopenia  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  0/9 (0.00%) 
Neutropenia  1  4/8 (50.00%)  4/9 (44.44%)  3/8 (37.50%)  3/8 (37.50%)  2/9 (22.22%) 
Cardiac disorders           
Ventricular extrasystoles  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Atrial fibrillation  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Ear and labyrinth disorders           
Ear discomfort  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Vertigo positional  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Vertigo  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%) 
Endocrine disorders           
Hyperthyroidism  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Eye disorders           
Retinopathy  1  1/8 (12.50%)  2/9 (22.22%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Dry eye  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Eyelids pruritus  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Retinal haemorrhage  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Eyelid oedema  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Ocular hyperaemia  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Vitreous floaters  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Conjunctival hyperaemia  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Retinal exudates  1  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders           
Abdominal discomfort  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Diarrhoea  1  3/8 (37.50%)  1/9 (11.11%)  1/8 (12.50%)  1/8 (12.50%)  3/9 (33.33%) 
Gastrooesophageal reflux disease  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorder  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Stomatitis  1  2/8 (25.00%)  1/9 (11.11%)  1/8 (12.50%)  1/8 (12.50%)  1/9 (11.11%) 
Constipation  1  0/8 (0.00%)  2/9 (22.22%)  2/8 (25.00%)  0/8 (0.00%)  1/9 (11.11%) 
Food poisoning  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Abdominal pain lower  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Gingival swelling  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Tongue disorder  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Abdominal pain upper  1  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Aphthous stomatitis  1  0/8 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%) 
Dry mouth  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Tooth loss  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Cheilitis  1  3/8 (37.50%)  2/9 (22.22%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Haemorrhoids  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Dental caries  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/9 (22.22%) 
Dyspepsia  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Nausea  1  2/8 (25.00%)  2/9 (22.22%)  2/8 (25.00%)  2/8 (25.00%)  2/9 (22.22%) 
Pancreatitis acute  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Vomiting  1  3/8 (37.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
General disorders           
Influenza like illness  1  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Injection site haemorrhage  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Injection site haematoma  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Injection site reaction  1  1/8 (12.50%)  4/9 (44.44%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Irritability  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Thirst  1  0/8 (0.00%)  0/9 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/9 (0.00%) 
Fatigue  1  4/8 (50.00%)  4/9 (44.44%)  2/8 (25.00%)  3/8 (37.50%)  2/9 (22.22%) 
Feeling abnormal  1  0/8 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Injection site erythema  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%) 
Pyrexia  1  5/8 (62.50%)  6/9 (66.67%)  5/8 (62.50%)  6/8 (75.00%)  8/9 (88.89%) 
Chills  1  4/8 (50.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Malaise  1  5/8 (62.50%)  1/9 (11.11%)  4/8 (50.00%)  2/8 (25.00%)  5/9 (55.56%) 
Chest discomfort  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Temperature intolerance  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Administration site reaction  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Chest pain  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Injection site pruritus  1  1/8 (12.50%)  2/9 (22.22%)  0/8 (0.00%)  0/8 (0.00%)  2/9 (22.22%) 
Infections and infestations           
Cystitis  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Hordeolum  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Gastroenteritis  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/9 (0.00%) 
Onychomycosis  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Otitis externa  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Rhinitis  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Vulvovaginitis  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Oral herpes  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Pharyngitis  1  2/8 (25.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Tinea pedis  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Nasopharyngitis  1  3/8 (37.50%)  1/9 (11.11%)  3/8 (37.50%)  1/8 (12.50%)  1/9 (11.11%) 
Injury, poisoning and procedural complications           
Anal injury  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Ankle fracture  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Heat illness  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Wound  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Contusion  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Rib fracture  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Investigations           
Blood glucose increased  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Gamma-glutamyltransferase increased  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Weight decreased  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Body temperature decreased  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Aspartate aminotransferase increased  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Blood bilirubin increased  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  5/8 (62.50%)  2/9 (22.22%)  5/8 (62.50%)  4/8 (50.00%)  4/9 (44.44%) 
Dehydration  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders           
Muscle rigidity  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Muscular weakness  1  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Musculoskeletal pain  1  2/8 (25.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Myalgia  1  2/8 (25.00%)  1/9 (11.11%)  0/8 (0.00%)  2/8 (25.00%)  1/9 (11.11%) 
Arthralgia  1  2/8 (25.00%)  2/9 (22.22%)  2/8 (25.00%)  2/8 (25.00%)  3/9 (33.33%) 
Back pain  1  2/8 (25.00%)  2/9 (22.22%)  1/8 (12.50%)  0/8 (0.00%)  4/9 (44.44%) 
Musculoskeletal stiffness  1  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Muscle haemorrhage  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Pain in extremity  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Nervous system disorders           
Head discomfort  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Hypogeusia  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Dysgeusia  1  1/8 (12.50%)  2/9 (22.22%)  2/8 (25.00%)  0/8 (0.00%)  1/9 (11.11%) 
Paraesthesia  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Visual field defect  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Headache  1  4/8 (50.00%)  3/9 (33.33%)  0/8 (0.00%)  4/8 (50.00%)  4/9 (44.44%) 
Dizziness  1  1/8 (12.50%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Psychiatric disorders           
Insomnia  1  2/8 (25.00%)  4/9 (44.44%)  3/8 (37.50%)  2/8 (25.00%)  3/9 (33.33%) 
Renal and urinary disorders           
Pollakiuria  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Nocturia  1  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Reproductive system and breast disorders           
Menstrual disorder  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Vulvovaginal pruritus  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Choking sensation  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Dyspnoea  1  0/8 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Oropharyngeal pain  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Pleural effusion  1  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Productive cough  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/9 (11.11%) 
Sputum retention  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Cough  1  1/8 (12.50%)  2/9 (22.22%)  2/8 (25.00%)  1/8 (12.50%)  5/9 (55.56%) 
Dyspnoea exertional  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Epistaxis  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%) 
Upper respiratory tract inflammation  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Oropharyngeal discomfort  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders           
Pruritus generalised  1  1/8 (12.50%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Alopecia  1  6/8 (75.00%)  3/9 (33.33%)  5/8 (62.50%)  2/8 (25.00%)  3/9 (33.33%) 
Seborrhoeic dermatitis  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Dry skin  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/9 (22.22%) 
Rash  1  3/8 (37.50%)  5/9 (55.56%)  2/8 (25.00%)  0/8 (0.00%)  1/9 (11.11%) 
Rash generalised  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Pruritus  1  3/8 (37.50%)  3/9 (33.33%)  3/8 (37.50%)  3/8 (37.50%)  1/9 (11.11%) 
Urticaria  1  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Acne  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Erythema  1  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%) 
Hyperkeratosis  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Eczema  1  2/8 (25.00%)  1/9 (11.11%)  2/8 (25.00%)  1/8 (12.50%)  0/9 (0.00%) 
Rash pruritic  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Skin exfoliation  1  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Vascular disorders           
Orthostatic hypotension  1  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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 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
Layout table for Results Point of Contact information
Name/Title: BristolMyers Squibb Study Director
Organization: Bristol­Myers Squibb International Corporation
EMail: clinical.trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01017575     History of Changes
Other Study ID Numbers: AI444-022
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: August 13, 2015
Results First Posted: September 11, 2015
Last Update Posted: September 11, 2015