Trial Outcomes & Findings for Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1) (NCT NCT00104052)
NCT ID: NCT00104052
Last Updated: 2017-04-04
Results Overview
SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
Up to 48-week treatment duration. Follow-up of 24 weeks.
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
PEG-Intron Plus REBETOL
SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (\<600,000 IU/mL), the same treatment will be given for 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
PEG-Intron Plus REBETOL
SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (\<600,000 IU/mL), the same treatment will be given for 24 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
26
|
|
Overall Study
Discontinuation unrelated to treatment
|
2
|
Baseline Characteristics
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
Baseline characteristics by cohort
| Measure |
PEG-Intron Plus REBETOL
n=107 Participants
SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (\<600,000 IU/mL), the same treatment will be given for 24 weeks.
|
|---|---|
|
Age, Continuous
|
9.7 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48-week treatment duration. Follow-up of 24 weeks.Population: Carry Forward analysis of participants who received at least one dose of study medication. This dataset includes one subject with undetectable HCV-RNA at Follow-up Week 12 (FW 12) but missing data at FW 24; this subject was considered a sustained responder in the Carry Forward analysis.
SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment
Outcome measures
| Measure |
PEG-Intron Plus REBETOL
n=107 Participants
SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (\<600,000 IU/mL), the same treatment will be given for 24 weeks.
|
|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment
|
70 Participants
|
Adverse Events
PEG-Intron Plus REBETOL
Serious events: 3 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-Intron Plus REBETOL
n=107 participants at risk
|
|---|---|
|
Cardiac disorders
PALPITATIONS
|
0.93%
1/107 • Number of events 1
|
|
Injury, poisoning and procedural complications
CARBON MONOXIDE POISONING
|
0.93%
1/107 • Number of events 1
|
|
Injury, poisoning and procedural complications
FALL
|
0.93%
1/107 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.93%
1/107 • Number of events 1
|
Other adverse events
| Measure |
PEG-Intron Plus REBETOL
n=107 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.2%
12/107 • Number of events 20
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
10.3%
11/107 • Number of events 15
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
9.3%
10/107 • Number of events 14
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
32.7%
35/107 • Number of events 61
|
|
Eye disorders
EYE PAIN
|
5.6%
6/107 • Number of events 7
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
26.2%
28/107 • Number of events 58
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
14.0%
15/107 • Number of events 24
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
5.6%
6/107 • Number of events 12
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.0%
16/107 • Number of events 20
|
|
Gastrointestinal disorders
NAUSEA
|
20.6%
22/107 • Number of events 41
|
|
Gastrointestinal disorders
VOMITING
|
33.6%
36/107 • Number of events 76
|
|
General disorders
ASTHENIA
|
15.0%
16/107 • Number of events 40
|
|
General disorders
CHILLS
|
21.5%
23/107 • Number of events 58
|
|
General disorders
FATIGUE
|
29.9%
32/107 • Number of events 125
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
9.3%
10/107 • Number of events 51
|
|
General disorders
INJECTION SITE ERYTHEMA
|
29.0%
31/107 • Number of events 50
|
|
General disorders
IRRITABILITY
|
15.0%
16/107 • Number of events 42
|
|
General disorders
MALAISE
|
9.3%
10/107 • Number of events 24
|
|
General disorders
PAIN
|
9.3%
10/107 • Number of events 20
|
|
General disorders
PYREXIA
|
80.4%
86/107 • Number of events 617
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.3%
11/107 • Number of events 15
|
|
Infections and infestations
PHARYNGITIS
|
5.6%
6/107 • Number of events 7
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
5.6%
6/107 • Number of events 6
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
5.6%
6/107 • Number of events 9
|
|
Investigations
WEIGHT DECREASED
|
18.7%
20/107 • Number of events 29
|
|
Metabolism and nutrition disorders
ANOREXIA
|
29.0%
31/107 • Number of events 41
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
22.4%
24/107 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.8%
18/107 • Number of events 70
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.5%
8/107 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
18.7%
20/107 • Number of events 100
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.3%
11/107 • Number of events 28
|
|
Nervous system disorders
DIZZINESS
|
14.0%
15/107 • Number of events 25
|
|
Nervous system disorders
HEADACHE
|
66.4%
71/107 • Number of events 410
|
|
Psychiatric disorders
NERVOUSNESS
|
8.4%
9/107 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
22.4%
24/107 • Number of events 31
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.5%
7/107 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
14.0%
15/107 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
ACNE
|
5.6%
6/107 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
17.8%
19/107 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
14.0%
15/107 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
8.4%
9/107 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
7.5%
8/107 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.5%
8/107 • Number of events 14
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60