Trial Outcomes & Findings for The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833) (NCT NCT00441584)
NCT ID: NCT00441584
Last Updated: 2017-04-05
Results Overview
Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is \< 30 IU/mL in this study.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Up to 48 weeks of treatment plus 24 weeks follow up
Results posted on
2017-04-05
Participant Flow
The majority of subjects who discontinued due to treatment failure were withdrawn from the study as non-responders according to protocol requirements.
Participant milestones
| Measure |
PegIntron Plus Rebetol
PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
105
|
Reasons for withdrawal
| Measure |
PegIntron Plus Rebetol
PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
|
|---|---|
|
Overall Study
Lack of Efficacy
|
79
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Failure to meet eligibility criteria
|
3
|
Baseline Characteristics
The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833)
Baseline characteristics by cohort
| Measure |
PegIntron Plus Rebetol
n=117 Participants
PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
|
|---|---|
|
Age, Continuous
|
48.54 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks of treatment plus 24 weeks follow upPopulation: The All Treated population included all subjects who took at least one dose of study medication.
Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is \< 30 IU/mL in this study.
Outcome measures
| Measure |
PegIntron Plus Rebetol
n=117 Participants
PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
|
|---|---|
|
Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment
|
1 Participants
|
Adverse Events
PegIntron Plus REBETOL
Serious events: 6 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron Plus REBETOL
n=117 participants at risk
|
|---|---|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.85%
1/117 • Number of events 1
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.85%
1/117 • Number of events 1
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.85%
1/117 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.85%
1/117 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.85%
1/117 • Number of events 1
|
|
Nervous system disorders
INTENTION TREMOR
|
0.85%
1/117 • Number of events 1
|
|
Nervous system disorders
PRESYNCOPE
|
0.85%
1/117 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
0.85%
1/117 • Number of events 1
|
|
Psychiatric disorders
PSEUDODEMENTIA
|
0.85%
1/117 • Number of events 1
|
Other adverse events
| Measure |
PegIntron Plus REBETOL
n=117 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.8%
8/117 • Number of events 8
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
10.3%
12/117 • Number of events 16
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.1%
6/117 • Number of events 6
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.0%
7/117 • Number of events 8
|
|
Gastrointestinal disorders
NAUSEA
|
14.5%
17/117 • Number of events 20
|
|
General disorders
ASTHENIA
|
24.8%
29/117 • Number of events 40
|
|
General disorders
CHILLS
|
11.1%
13/117 • Number of events 15
|
|
General disorders
FATIGUE
|
28.2%
33/117 • Number of events 37
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
21.4%
25/117 • Number of events 86
|
|
General disorders
INJECTION SITE ERYTHEMA
|
11.1%
13/117 • Number of events 13
|
|
General disorders
INJECTION SITE REACTION
|
8.5%
10/117 • Number of events 25
|
|
General disorders
IRRITABILITY
|
7.7%
9/117 • Number of events 9
|
|
General disorders
PYREXIA
|
19.7%
23/117 • Number of events 32
|
|
Infections and infestations
INFLUENZA
|
14.5%
17/117 • Number of events 18
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
6.0%
7/117 • Number of events 7
|
|
Metabolism and nutrition disorders
ANOREXIA
|
12.0%
14/117 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
14.5%
17/117 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.1%
6/117 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.4%
18/117 • Number of events 20
|
|
Nervous system disorders
DIZZINESS
|
6.0%
7/117 • Number of events 7
|
|
Nervous system disorders
HEADACHE
|
24.8%
29/117 • Number of events 31
|
|
Psychiatric disorders
DEPRESSION
|
8.5%
10/117 • Number of events 11
|
|
Psychiatric disorders
INSOMNIA
|
6.8%
8/117 • Number of events 10
|
|
Psychiatric disorders
SLEEP DISORDER
|
10.3%
12/117 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.9%
21/117 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.4%
11/117 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.1%
6/117 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.4%
11/117 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
6.0%
7/117 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.8%
8/117 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
15.4%
18/117 • Number of events 18
|
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