Trial Outcomes & Findings for Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) (NCT NCT00723645)
NCT ID: NCT00723645
Last Updated: 2015-11-30
Results Overview
Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid
COMPLETED
279 participants
From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment
2015-11-30
Participant Flow
Participants who had achieved a viral response prior to this study (negative for Hepatitis C Virus \[HCV\] ribonucleic acid \[RNA\] at the end of treatment as per product label) were recruited for follow-up on the present study.
A total of 279 participants enrolled in the study. Twenty-one participants failed screening and 258 participants were evaluable at Visit 1 (V1), which could be performed up to Week (Wk) 4 after the end of treatment.
Participant milestones
| Measure |
PEG IFN Alfa-2b + RBV
Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
|
|---|---|
|
Visit 1 (≤4 Weeks Post-treatment)
STARTED
|
258
|
|
Visit 1 (≤4 Weeks Post-treatment)
COMPLETED
|
258
|
|
Visit 1 (≤4 Weeks Post-treatment)
NOT COMPLETED
|
0
|
|
Visit 2 (Week 24 Post-treatment)
STARTED
|
248
|
|
Visit 2 (Week 24 Post-treatment)
COMPLETED
|
248
|
|
Visit 2 (Week 24 Post-treatment)
NOT COMPLETED
|
0
|
|
Visit 3 (Week 72 Post-treatment)
STARTED
|
187
|
|
Visit 3 (Week 72 Post-treatment)
COMPLETED
|
187
|
|
Visit 3 (Week 72 Post-treatment)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)
Baseline characteristics by cohort
| Measure |
PEG IFN Alfa-2b + RBV
n=258 Participants
Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
|
|---|---|
|
Age, Continuous
|
45.72 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatmentPopulation: The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).
Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid
Outcome measures
| Measure |
PEG IFN Alfa-2b + RBV
n=249 Participants
Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
|
|---|---|
|
Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)
|
13.65 Percentage of participants
Interval 9.39 to 17.92
|
SECONDARY outcome
Timeframe: From 24 weeks post-treatment to 72 weeks post-treatmentPopulation: The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2). 187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3).
Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up.
Outcome measures
| Measure |
PEG IFN Alfa-2b + RBV
n=173 Participants
Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
|
|---|---|
|
Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)
|
0.58 Percentage of participants
Interval 0.0 to 1.71
|
Adverse Events
PEG IFN Alfa-2b + RBV
Serious adverse events
| Measure |
PEG IFN Alfa-2b + RBV
n=258 participants at risk
Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
|
|---|---|
|
General disorders
Drowning
|
0.39%
1/258 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/258 • Number of events 1
|
|
Nervous system disorders
Spinal Hematoma
|
0.39%
1/258 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.39%
1/258 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.39%
1/258 • Number of events 1
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
0.39%
1/258 • Number of events 1
|
Other adverse events
| Measure |
PEG IFN Alfa-2b + RBV
n=258 participants at risk
Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
13/258 • Number of events 13
|
|
General disorders
Asthenia
|
6.2%
16/258 • Number of events 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place