Trial Outcomes & Findings for Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease (NCT NCT00028093)
NCT ID: NCT00028093
Last Updated: 2013-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
From day 0 to day 3
Results posted on
2013-11-08
Participant Flow
Participant milestones
| Measure |
Peginterferon+Ribavirin
peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
|
Peginterferon Alone
peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease
Baseline characteristics by cohort
| Measure |
Peginterferon+Ribavirin
n=25 Participants
peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
|
Peginterferon Alone
n=25 Participants
peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49 years
n=99 Participants
|
52 years
n=107 Participants
|
51 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 participants
n=99 Participants
|
21 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Duration of infection
|
23 year
STANDARD_DEVIATION 9.0 • n=99 Participants
|
23 year
STANDARD_DEVIATION 7.7 • n=107 Participants
|
23 year
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Mode of infection
Injection drug use
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Mode of infection
Blood transfusion
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Mode of infection
Other
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Mode of infection
Unknown
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Weight
|
78.1 kg
STANDARD_DEVIATION 17 • n=99 Participants
|
76.8 kg
STANDARD_DEVIATION 19 • n=107 Participants
|
77.5 kg
STANDARD_DEVIATION 18.0 • n=206 Participants
|
|
Body Mass Index
|
26.9 kg/(m^2)
STANDARD_DEVIATION 4.9 • n=99 Participants
|
27.0 kg/(m^2)
STANDARD_DEVIATION 4.8 • n=107 Participants
|
27.0 kg/(m^2)
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Alanine transaminase
|
69 U/L
STANDARD_DEVIATION 61 • n=99 Participants
|
96 U/L
STANDARD_DEVIATION 79 • n=107 Participants
|
83 U/L
STANDARD_DEVIATION 71 • n=206 Participants
|
|
Ishak fibrosis
0-2
|
15 participant
n=99 Participants
|
16 participant
n=107 Participants
|
31 participant
n=206 Participants
|
|
Ishak fibrosis
3-6
|
10 participant
n=99 Participants
|
9 participant
n=107 Participants
|
19 participant
n=206 Participants
|
|
Histology activity index
|
8 Units on a scale
n=99 Participants
|
8 Units on a scale
n=107 Participants
|
8 Units on a scale
n=206 Participants
|
|
Hepatitis C Virus RNA level
|
6.2 log(IU/mL)
STANDARD_DEVIATION 0.53 • n=99 Participants
|
6.2 log(IU/mL)
STANDARD_DEVIATION 0.58 • n=107 Participants
|
6.2 log(IU/mL)
STANDARD_DEVIATION 0.56 • n=206 Participants
|
PRIMARY outcome
Timeframe: From day 0 to day 3Outcome measures
| Measure |
Peginterferon+Ribavirin
n=24 Participants
|
Peginterferon
n=24 Participants
|
|---|---|---|
|
Change in Hepatitis C Virus RNA Levels During Phase I
|
0.50 log(IU/mL)
Interval -0.4 to 2.3
|
0.70 log(IU/mL)
Interval -0.1 to 1.7
|
Adverse Events
Peginterferon+Ribavirin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peginterferon Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Combination of Pegylated Interferon and Ribavirin as Therapy for Patients With Chronic Hepatitis C W
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 3014961333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place