Trial Outcomes & Findings for Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant (NCT NCT02032875)
NCT ID: NCT02032875
Last Updated: 2017-02-09
Results Overview
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (\<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
116 participants
Primary outcome timeframe
Post-treatment follow-up Week 12
Results posted on
2017-02-09
Participant Flow
The study was conducted at 5 centers in the United States.
A total of 116 participants were enrolled, of which 113 received study treatment (60 cirrhotic cohort, 53: post-liver transplant cohort). Remaining 3 participants no longer met study criteria. Of the 60 participants in the cirrhotic cohort, 57 did not receive a treatment extension and 3 received a treatment extension after liver transplant.
Participant milestones
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Treatment Period
STARTED
|
53
|
60
|
|
Treatment Period
COMPLETED
|
52
|
56
|
|
Treatment Period
NOT COMPLETED
|
1
|
4
|
|
Follow-up Period
STARTED
|
53
|
57
|
|
Follow-up Period
COMPLETED
|
50
|
46
|
|
Follow-up Period
NOT COMPLETED
|
3
|
11
|
Reasons for withdrawal
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
0
|
|
Treatment Period
Liver transplant, No extension needed
|
0
|
1
|
|
Treatment Period
Liver transplant, Treatment extension
|
0
|
3
|
|
Follow-up Period
Death
|
0
|
1
|
|
Follow-up Period
Virologic Relapse
|
3
|
10
|
Baseline Characteristics
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
Baseline characteristics by cohort
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 8.25 • n=93 Participants
|
57.9 years
STANDARD_DEVIATION 9.45 • n=4 Participants
|
58.7 years
STANDARD_DEVIATION 8.91 • n=27 Participants
|
|
Age, Customized
<65 years
|
42 participants
n=93 Participants
|
50 participants
n=4 Participants
|
92 participants
n=27 Participants
|
|
Age, Customized
>=65 years
|
11 participants
n=93 Participants
|
10 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Gender
Female
|
15 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Gender
Male
|
38 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Hepatitis C Virus RNA
|
6.61 log10 IU/mL
STANDARD_DEVIATION 0.711 • n=93 Participants
|
6.01 log10 IU/mL
STANDARD_DEVIATION 0.617 • n=4 Participants
|
6.29 log10 IU/mL
STANDARD_DEVIATION 0.724 • n=27 Participants
|
|
Hepatitis C Virus RNA distribution
<800,000 IU/mL
|
6 participants
n=93 Participants
|
27 participants
n=4 Participants
|
33 participants
n=27 Participants
|
|
Hepatitis C Virus RNA distribution
≥800,000 IU/mL
|
47 participants
n=93 Participants
|
33 participants
n=4 Participants
|
80 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 1a
|
31 participants
n=93 Participants
|
34 participants
n=4 Participants
|
65 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 1b
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 2
|
0 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 3
|
11 participants
n=93 Participants
|
6 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 4
|
0 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 5
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
HCV genotype subtype
Hepatitis C Virus genotype 6
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
IL-28B rs1297860 Genotype
CC
|
13 participants
n=93 Participants
|
13 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
IL-28B rs1297860 Genotype
CT
|
31 participants
n=93 Participants
|
33 participants
n=4 Participants
|
64 participants
n=27 Participants
|
|
IL-28B rs1297860 Genotype
TT
|
9 participants
n=93 Participants
|
14 participants
n=4 Participants
|
23 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Post-treatment follow-up Week 12Population: All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy.
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (\<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=41 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
|
95.1 Percentage of participants
Interval 83.5 to 99.4
|
—
|
PRIMARY outcome
Timeframe: Post-treatment follow-up Week 12Population: All genotype 1 cirrhotic participants who received at least 1 dose of study therapy.
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=45 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
|
82.2 Percentage of participants
Interval 67.9 to 92.0
|
—
|
SECONDARY outcome
Timeframe: Post-treatment follow-up Week 12Population: All treated participants who took at least 1 dose of study medication. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
All Genotypes (n =53, 60)
|
94.3 Percentage of participants
Interval 84.3 to 98.8
|
83.3 Percentage of participants
Interval 71.5 to 91.7
|
|
Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
HCV Genotype 2 (n =0, 5)
|
NA Percentage of participants
As none of the participants were evaluable for this reporting arm, the percentage value was not applicable.
|
80 Percentage of participants
Interval 28.4 to 99.5
|
|
Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
HCV Genotype 3 (n =11, 6)
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
HCV Genotype 4 (n =0, 4)
|
NA Percentage of participants
As none of the participants were evaluable for this reporting arm, the percentage value was not applicable.
|
100 Percentage of participants
Interval 39.8 to 100.0
|
|
Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
HCV Genotype 6 (n =1, 0)
|
100 Percentage of participants
Interval 2.5 to 100.0
|
NA Percentage of participants
As none of the participants were evaluable for this reporting arm, the percentage value was not applicable.
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24Population: All treated participants.
Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Week 1
|
22.6 Percentage of participants
Interval 12.3 to 36.2
|
15.0 Percentage of participants
Interval 7.1 to 26.6
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Week 2
|
67.9 Percentage of participants
Interval 53.7 to 80.1
|
45.0 Percentage of participants
Interval 32.1 to 58.4
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Week 4
|
94.3 Percentage of participants
Interval 84.3 to 98.8
|
95.0 Percentage of participants
Interval 86.1 to 99.0
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Week 6
|
96.2 Percentage of participants
Interval 87.0 to 99.5
|
91.7 Percentage of participants
Interval 81.6 to 97.2
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Week 8
|
98.1 Percentage of participants
Interval 89.9 to 100.0
|
95.0 Percentage of participants
Interval 86.1 to 99.0
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Week 12
|
98.1 Percentage of participants
Interval 89.9 to 100.0
|
93.3 Percentage of participants
Interval 83.8 to 98.2
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
End of treatment
|
100.0 Percentage of participants
Interval 93.3 to 100.0
|
96.7 Percentage of participants
Interval 88.5 to 99.6
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Follow-up Week 4 (SVR4)
|
98.1 Percentage of participants
Interval 89.9 to 100.0
|
88.3 Percentage of participants
Interval 77.4 to 95.2
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Follow-up Week 8 (SVR8)
|
96.2 Percentage of participants
Interval 87.0 to 99.5
|
86.7 Percentage of participants
Interval 75.4 to 94.1
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Follow-up Week 24 (SVR24)
|
94.3 Percentage of participants
Interval 84.3 to 98.8
|
80.0 Percentage of participants
Interval 67.7 to 89.2
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatmentPopulation: All treated participants.
Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Week 1
|
3.8 Percentage of participants
Interval 0.5 to 13.0
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Week 2
|
13.2 Percentage of participants
Interval 5.5 to 25.3
|
11.7 Percentage of participants
Interval 4.8 to 22.6
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Week 4
|
56.6 Percentage of participants
Interval 42.3 to 70.2
|
53.3 Percentage of participants
Interval 40.0 to 66.3
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Week 6
|
84.9 Percentage of participants
Interval 72.4 to 93.3
|
76.7 Percentage of participants
Interval 64.0 to 86.6
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Week 8
|
98.1 Percentage of participants
Interval 89.9 to 100.0
|
93.3 Percentage of participants
Interval 83.8 to 98.2
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Week 12
|
98.1 Percentage of participants
Interval 89.9 to 100.0
|
93.3 Percentage of participants
Interval 83.8 to 98.2
|
|
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
End of treatment
|
100.0 Percentage of participants
Interval 93.3 to 100.0
|
96.7 Percentage of participants
Interval 88.5 to 99.6
|
SECONDARY outcome
Timeframe: Post-treatment follow-up Week 12Population: All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.
Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be \<lower limit of quantitation ie, 25 IU/mL or below 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)
CC type (n = 13, 13)
|
100 Percentage of participants
Interval 75.3 to 100.0
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
|
Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)
Non-CC type (n = 40, 47)
|
92.5 Percentage of participants
Interval 79.6 to 98.4
|
78.7 Percentage of participants
Interval 64.3 to 89.3
|
SECONDARY outcome
Timeframe: From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks)Population: All treated participants.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not 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.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
SAEs
|
5 participants
|
10 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
AEs leading to discontinuation
|
6 participants
|
10 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
AEs leading to interruption
|
1 participants
|
3 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
Treatment-related AEs
|
35 participants
|
37 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
Treatment-related SAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
Adverse events Grade 3 to 4
|
5 participants
|
11 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
Serious adverse events Grade 3 to 4
|
2 participants
|
8 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to 7 days post last dose of study treatmentPopulation: All treated participants.
Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or \< 6.5 g/dL for grade 4, Platelet count as 25\*10\^9-50\*10\^9 /L for grade 3 and/or \< 25.000\*10\^9 /L for grade 4, International normalized ratio as 2.1-3.0\*upper limit of normal (ULN) \> 3.0\*ULN for grade 3 and/or \> 3.0\*ULN for grade 4, Leukocytes as 1.0\*10\^9-1.5\*10\^9/L for grade 3 and/or \<1.0\*10\^9/L for grade 4, Lymphocytes (Absolute) as 0.350\*109-0.499\*10\^9 /L for grade 3 and/or \< 0.350\*10\^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0\*ULN for grade 3 and/or \> 10.0\*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0\*ULN for grade 3 and/or \> 10.0\*ULN for grade 4, Alkaline phosphatase as 5.1-10.0\*ULN for grade 3 and/or \> 10.0\*ULN for grade 4, Bilirubin (Total) as 2.6-5.0\*ULN for grade 3 and/or \> 5.0\*ULN for grade 4, Albumin as \< 20 g/L, Lipase (Total) as 3.1-5.0\*ULN for grade 3 and/or \> 5.0\*ULN for grade 4, and Creatinine as 1.9-3.4\*ULN for grade 3 and/or ≥ 3.5\*ULN for grade 4.
Outcome measures
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 Participants
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 Participants
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
International normalized ratio
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Hemoglobin
|
2 participants
|
5 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Platelet count
|
0 participants
|
4 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Leukocytes
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Lymphocytes (Absolute)
|
3 participants
|
6 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Alanine aminotransferase
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Aspartate aminotransferase
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Alkaline phosphatase
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Bilirubin (Total)
|
2 participants
|
9 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Albumin
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Lipase (Total)
|
2 participants
|
3 participants
|
|
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Creatinine
|
2 participants
|
2 participants
|
Adverse Events
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 participants at risk
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 participants at risk
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
0.00%
0/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
5.0%
3/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
0.00%
0/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
0.00%
0/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
0.00%
0/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Infections and infestations
Cellulitis
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
Other adverse events
| Measure |
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=53 participants at risk
Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin
n=60 participants at risk
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
7/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
5.0%
3/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Diarrhoea
|
18.9%
10/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
8.3%
5/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Blood and lymphatic system disorders
Anaemia
|
20.8%
11/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
21.7%
13/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Nervous system disorders
Somnolence
|
0.00%
0/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
5.0%
3/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Nervous system disorders
Headache
|
35.8%
19/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
15.0%
9/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
General disorders
Fatigue
|
28.3%
15/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
18.3%
11/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
General disorders
Oedema peripheral
|
7.5%
4/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
6.7%
4/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
3/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
3.3%
2/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Psychiatric disorders
Insomnia
|
7.5%
4/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
5.0%
3/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
3/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
3.3%
2/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Gastrointestinal disorders
Nausea
|
5.7%
3/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
16.7%
10/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
8.3%
5/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
3/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
1.7%
1/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
|
General disorders
Pyrexia
|
5.7%
3/53 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
5.0%
3/60 • From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER