Trial Outcomes & Findings for PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C (NCT NCT00100659)
NCT ID: NCT00100659
Last Updated: 2018-10-24
Results Overview
SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
at least 24 weeks after stopping treatment.
Results posted on
2018-10-24
Participant Flow
December 2004 to May 2006 at 11 US medical centers
Failure to meet inclusion criteria
Participant milestones
| Measure |
Pegylated Interferon/Ribavirin
Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets.
|
Pegylated Interferon/Placebo
Placebo tablets were supplied in the same dosing regimen as ribavirin (RV), using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
59
|
|
Overall Study
COMPLETED
|
52
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Baseline characteristics by cohort
| Measure |
Pegylated Interferon/Ribavirin
n=55 Participants
Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets.
|
Pegylated Interferon/Placebo
n=59 Participants
Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
55 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 3.3 • n=99 Participants
|
10.8 years
STANDARD_DEVIATION 3.6 • n=107 Participants
|
10.75 years
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=99 Participants
|
59 participants
n=107 Participants
|
114 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at least 24 weeks after stopping treatment.SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
Outcome measures
| Measure |
PEG/RV
n=55 Participants
Pegylated interferon/ribavirin
|
PEG/Placebo
n=57 Participants
Pegylated interferon/placebo
|
|---|---|---|
|
Sustained Viral Response (SVR)
|
29 participants
|
12 participants
|
SECONDARY outcome
Timeframe: At any time up to 72 weeksInfluenza-like, headache, and gastrointestinal symptoms
Outcome measures
| Measure |
PEG/RV
n=55 Participants
Pegylated interferon/ribavirin
|
PEG/Placebo
n=57 Participants
Pegylated interferon/placebo
|
|---|---|---|
|
Adverse Events
Influenza-like symptoms
|
50 Participants
|
50 Participants
|
|
Adverse Events
Headache
|
34 Participants
|
30 Participants
|
|
Adverse Events
Gastrointestinal symptoms
|
31 Participants
|
37 Participants
|
Adverse Events
Pegylated Interferon/Ribavirin
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Pegylated Interferon/Placebo
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegylated Interferon/Ribavirin
n=55 participants at risk
Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets.
|
Pegylated Interferon/Placebo
n=59 participants at risk
Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
|
|---|---|---|
|
Psychiatric disorders
Suicide gesture
|
1.8%
1/55 • Number of events 1
|
0.00%
0/59
|
|
Endocrine disorders
New onset diabetes mellitus Type 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/59
|
|
Hepatobiliary disorders
Complications of a liver biopsy
|
0.00%
0/55
|
1.7%
1/59 • Number of events 1
|
Other adverse events
| Measure |
Pegylated Interferon/Ribavirin
n=55 participants at risk
Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets.
|
Pegylated Interferon/Placebo
n=59 participants at risk
Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
|
|---|---|---|
|
General disorders
Flu-like symptoms
|
90.9%
50/55
|
84.7%
50/59
|
|
General disorders
Headache
|
61.8%
34/55
|
50.8%
30/59
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
56.4%
31/55
|
62.7%
37/59
|
|
General disorders
Injection site reaction
|
45.5%
25/55
|
45.8%
27/59
|
|
Musculoskeletal and connective tissue disorders
Joint and muscle aches
|
36.4%
20/55
|
33.9%
20/59
|
|
General disorders
Irritability
|
30.9%
17/55
|
22.0%
13/59
|
|
General disorders
Fatigue
|
27.3%
15/55
|
25.4%
15/59
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
11/55
|
23.7%
14/59
|
|
Skin and subcutaneous tissue disorders
Itching
|
14.5%
8/55
|
15.3%
9/59
|
|
General disorders
Anorexia
|
12.7%
7/55
|
18.6%
11/59
|
|
General disorders
Trouble sleeping
|
10.9%
6/55
|
18.6%
11/59
|
|
Psychiatric disorders
Depression
|
3.6%
2/55
|
11.9%
7/59
|
Additional Information
Kathleen B. Schwarz, M.D.
Johns Hopkins University School of Medicine
Phone: 410-955-8769
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60