Trial Outcomes & Findings for 5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2) (NCT NCT00761735)
NCT ID: NCT00761735
Last Updated: 2017-04-04
Results Overview
Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.
COMPLETED
PHASE3
94 participants
Part 2 LTFU Year 5
2017-04-04
Participant Flow
Of 107 participants who enrolled in Part 1 of this study and were potentially eligible for the Part 2 Long Term Follow-up (LTFU), 94 participants enrolled in the current LTFU study (Part 2).
Participant milestones
| Measure |
PEG-IFN + RBV: LTFU
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|
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Overall Study
STARTED
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94
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Overall Study
COMPLETED
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80
|
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Overall Study
NOT COMPLETED
|
14
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Reasons for withdrawal
| Measure |
PEG-IFN + RBV: LTFU
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|
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Overall Study
Lost to Follow-up
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6
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Overall Study
Withdrawal by Subject
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6
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Overall Study
Non-compliance with protocol
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1
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Overall Study
Administrative
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1
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Baseline Characteristics
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Baseline characteristics by cohort
| Measure |
PEG-IFN + RBV: LTFU
n=94 Participants
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|
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Age, Continuous
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9.9 years
STANDARD_DEVIATION 3.9 • n=5 Participants
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Sex: Female, Male
Female
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49 Participants
n=5 Participants
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Sex: Female, Male
Male
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45 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Part 2 LTFU Year 5Population: Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.
Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.
Outcome measures
| Measure |
PEG-IFN + RBV: LTFU (All)
n=54 Participants
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
|
PEG-IFN + RBV: LTFU (48 Weeks)
Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|---|
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Number of Participants Who Relapsed At End of LTFU Year 5
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0 participants
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—
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PRIMARY outcome
Timeframe: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)Population: All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.
To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.
Outcome measures
| Measure |
PEG-IFN + RBV: LTFU (All)
n=46 Participants
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
|
PEG-IFN + RBV: LTFU (48 Weeks)
n=48 Participants
Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|---|
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Mean Height Percentiles of Participants Over LTFU
LTFU Year 5 (n=38, n=42)
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47.61 percentile
Standard Deviation 29.57
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43.51 percentile
Standard Deviation 27.57
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Mean Height Percentiles of Participants Over LTFU
Part 1 Pre-treatment Baseline
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48.94 percentile
Standard Deviation 27.38
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52.5 percentile
Standard Deviation 29.98
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Mean Height Percentiles of Participants Over LTFU
LTFU Year 1 (n=40, n=44)
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49.21 percentile
Standard Deviation 29.03
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43.37 percentile
Standard Deviation 27.87
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Mean Height Percentiles of Participants Over LTFU
LTFU Year 2 (n=39, n=39)
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50.56 percentile
Standard Deviation 29.18
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46.24 percentile
Standard Deviation 29.19
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Mean Height Percentiles of Participants Over LTFU
LTFU Year 3 (n=39, n=44)
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48.05 percentile
Standard Deviation 28.38
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46.00 percentile
Standard Deviation 28.24
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Mean Height Percentiles of Participants Over LTFU
LTFU Year 4 (n=40, n=38)
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49.62 percentile
Standard Deviation 30.87
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45.27 percentile
Standard Deviation 29.44
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Mean Height Percentiles of Participants Over LTFU
Last Available LTFU Visit (n=46, n=48)
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45.96 percentile
Standard Deviation 30.45
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43.56 percentile
Standard Deviation 27.19
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PRIMARY outcome
Timeframe: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)Population: All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.
To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.
Outcome measures
| Measure |
PEG-IFN + RBV: LTFU (All)
n=46 Participants
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
|
PEG-IFN + RBV: LTFU (48 Weeks)
n=48 Participants
Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|---|
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Mean Weight Percentiles of Participants Over LTFU
LTFU Year 5 (n=38, n=42)
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51.16 percentile
Standard Deviation 27.16
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53.12 percentile
Standard Deviation 31.38
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Mean Weight Percentiles of Participants Over LTFU
Part 1 Pre-treatment Baseline
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52.5 percentile
Standard Deviation 26.83
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58.56 percentile
Standard Deviation 30.56
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Mean Weight Percentiles of Participants Over LTFU
LTFU Year 1 (n=40, n=44)
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53.62 percentile
Standard Deviation 26.75
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56.38 percentile
Standard Deviation 30.55
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Mean Weight Percentiles of Participants Over LTFU
LTFU Year 2 (n=39, n=39)
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51.73 percentile
Standard Deviation 26.89
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52.03 percentile
Standard Deviation 30.47
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Mean Weight Percentiles of Participants Over LTFU
LTFU Year 3 (n=39, n=44)
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53.18 percentile
Standard Deviation 29.12
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54.26 percentile
Standard Deviation 30.37
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Mean Weight Percentiles of Participants Over LTFU
LTFU Year 4 (n=40, n=38)
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51.75 percentile
Standard Deviation 28.90
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49.50 percentile
Standard Deviation 30.37
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Mean Weight Percentiles of Participants Over LTFU
Last Available LTFU Visit (n=46, n=48)
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50.15 percentile
Standard Deviation 28.44
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55.53 percentile
Standard Deviation 30.67
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PRIMARY outcome
Timeframe: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)Population: All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.
To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.
Outcome measures
| Measure |
PEG-IFN + RBV: LTFU (All)
n=46 Participants
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
|
PEG-IFN + RBV: LTFU (48 Weeks)
n=48 Participants
Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|---|
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
LTFU Year 5 (n=38, n=42)
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48.61 percentile
Standard Deviation 29.72
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52.34 percentile
Standard Deviation 31.87
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
Part 1 Pre-treatment Baseline
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50.4 percentile
Standard Deviation 29.63
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59.76 percentile
Standard Deviation 31.52
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
LTFU Year 1 (n=40, n=44)
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51.15 percentile
Standard Deviation 30.27
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59.91 percentile
Standard Deviation 31.55
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
LTFU Year 2 (n=39, n=39)
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48.11 percentile
Standard Deviation 29.59
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52.89 percentile
Standard Deviation 30.82
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
LTFU Year 3 (n=39, n=44)
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52.14 percentile
Standard Deviation 31.00
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54.96 percentile
Standard Deviation 30.89
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
LTFU Year 4 (n=40, n=38)
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48.44 percentile
Standard Deviation 30.46
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48.69 percentile
Standard Deviation 31.52
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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
Last Available LTFU Visit (n=46, n=48)
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48.79 percentile
Standard Deviation 29.40
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55.38 percentile
Standard Deviation 31.48
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PRIMARY outcome
Timeframe: Last assessment of the Part 2 LTFU (up to 5 years)Population: All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.
The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.
Outcome measures
| Measure |
PEG-IFN + RBV: LTFU (All)
n=41 Participants
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
|
PEG-IFN + RBV: LTFU (48 Weeks)
n=42 Participants
Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|---|
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Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
Age of TS 1 participants (n=4, n=5)
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9.75 years
Standard Deviation 1.13
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11.00 years
Standard Deviation 0.80
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Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
Age of TS 2 participants (n=5, n=3)
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11.86 years
Standard Deviation 0.78
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12.53 years
Standard Deviation 1.27
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Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
Age of TS 3 participants (n=7, n=1)
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15.26 years
Standard Deviation 4.64
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13.60 years
Standard Deviation 0
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Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
Age of TS 4 participants (n=4, n=6)
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16.00 years
Standard Deviation 4.31
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14.75 years
Standard Deviation 1.47
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Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
Age of TS 5 participants (n=21, n=27)
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17.37 years
Standard Deviation 2.71
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19.18 years
Standard Deviation 2.48
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Adverse Events
PEG-IFN + RBV: LTFU
Serious adverse events
| Measure |
PEG-IFN + RBV: LTFU
n=94 participants at risk
Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
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|---|---|
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Congenital, familial and genetic disorders
Talipes
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1.1%
1/94 • Number of events 3 • 5 years, starting after the Part 1 post-treatment Follow-up Week 24 visit
Only serious adverse events were collected during this 5 year LTFU study.
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Infections and infestations
Appendicitis
|
2.1%
2/94 • Number of events 2 • 5 years, starting after the Part 1 post-treatment Follow-up Week 24 visit
Only serious adverse events were collected during this 5 year LTFU study.
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Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (1) proprietary information that is protected, (2) the accuracy of the information contained in the publication, and (3) to ensure that the presentation is fairly balanced and in compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER