Trial Outcomes & Findings for 100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC) (NCT NCT01378104)
NCT ID: NCT01378104
Last Updated: 2013-03-08
Results Overview
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
178 participants
Primary outcome timeframe
post treatment 24 weeks
Results posted on
2013-03-08
Participant Flow
enrollment date : 2009-2011 recruitment period : 2009-2012 type location: 14 university hospital
no excluded patients before assignment to groups
Participant milestones
| Measure |
100% Dosage Group of Peginterferon Alfa 2a
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
|
80% Dosage Group of Peginterferon Alfa 2a
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
86
|
|
Overall Study
COMPLETED
|
65
|
60
|
|
Overall Study
NOT COMPLETED
|
27
|
26
|
Reasons for withdrawal
| Measure |
100% Dosage Group of Peginterferon Alfa 2a
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
|
80% Dosage Group of Peginterferon Alfa 2a
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
8
|
|
Overall Study
Lack of Efficacy
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
12
|
13
|
Baseline Characteristics
100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
Baseline characteristics by cohort
| Measure |
100% Dosage Group of Peginterferon Alfa 2a
n=92 Participants
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
|
80% Dosage Group of Peginterferon Alfa 2a
n=86 Participants
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age Continuous
|
48.5 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
48.7 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
92 participants
n=93 Participants
|
86 participants
n=4 Participants
|
178 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: post treatment 24 weeksPopulation: We present the result of intention-to-treat analysis.
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
Outcome measures
| Measure |
100% Dosage Group of Peginterferon Alfa 2a
n=92 Participants
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
|
80% Dosage Group of Peginterferon Alfa 2a
n=86 Participants
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
|
|---|---|---|
|
Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
|
52 participants who achieved SVR
|
44 participants who achieved SVR
|
SECONDARY outcome
Timeframe: post treatment 24 weeksPopulation: The patients who agreed to check the genotype were analysed.
We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.
Outcome measures
| Measure |
100% Dosage Group of Peginterferon Alfa 2a
n=82 Participants
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
|
80% Dosage Group of Peginterferon Alfa 2a
n=18 Participants
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
|
|---|---|---|
|
IL28B Polymorphism Effect on SVR
|
71.9 percentage of SVR
|
33.3 percentage of SVR
|
Adverse Events
100% Dosage Group of Peginterferon Alfa 2a
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
80% Dosage Group of Peginterferon Alfa 2a
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100% Dosage Group of Peginterferon Alfa 2a
n=92 participants at risk
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
|
80% Dosage Group of Peginterferon Alfa 2a
n=86 participants at risk
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
|
|---|---|---|
|
Blood and lymphatic system disorders
laboratory adverse events
|
48.9%
45/92 • Number of events 54
|
57.0%
49/86 • Number of events 49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place