Trial Outcomes & Findings for Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED) (NCT NCT00727311)
NCT ID: NCT00727311
Last Updated: 2015-10-09
Results Overview
HCV-RNA level was measured by polymerase chain reaction (PCR).
Recruitment status
COMPLETED
Target enrollment
2302 participants
Primary outcome timeframe
24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
Results posted on
2015-10-09
Participant Flow
Participant milestones
| Measure |
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Overall Study
STARTED
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2302
|
|
Overall Study
COMPLETED
|
1195
|
|
Overall Study
NOT COMPLETED
|
1107
|
Reasons for withdrawal
| Measure |
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Overall Study
Did not receive drug
|
316
|
|
Overall Study
Missing end of therapy data
|
205
|
|
Overall Study
Adverse Event
|
58
|
|
Overall Study
Lack of Efficacy
|
242
|
|
Overall Study
Lost to Follow-up
|
73
|
|
Overall Study
Withdrawal by Subject
|
77
|
|
Overall Study
Other
|
97
|
|
Overall Study
Multiple reasons
|
39
|
Baseline Characteristics
Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PegIntron + Rebetol
n=2302 Participants
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Age, Continuous
|
42.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
1169 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
766 participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender information not captured
|
367 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2302 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6Population: Number of evaluable participants at EoT
HCV-RNA level was measured by polymerase chain reaction (PCR).
Outcome measures
| Measure |
PegIntron + Rebetol
n=1781 Participants
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
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1306 Participants
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PRIMARY outcome
Timeframe: Treatment Week 12Population: Number of evaluable participants at 12 weeks of treatment
EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12
Outcome measures
| Measure |
PegIntron + Rebetol
n=1823 Participants
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Number of Participants With Early Virologic Response (EVR)
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1168 Participants
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PRIMARY outcome
Timeframe: 24 weeks post-treatment (Week 48 or 72, depending on genotype)Population: Number of evaluable participants with follow-up information
SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT
Outcome measures
| Measure |
PegIntron + Rebetol
n=1986 Participants
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Number of Participants With Sustained Virologic Response (SVR)
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888 Participants
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PRIMARY outcome
Timeframe: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)Population: Number of participants with results at the 6 month follow-up examination
HCV-RNA was measured by PCR.
Outcome measures
| Measure |
PegIntron + Rebetol
n=1616 Participants
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.
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|---|---|
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Number of HCV-RNA Negative Participants at Follow-up
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887 Participants
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Adverse Events
All Participants
Serious events: 58 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=2302 participants at risk
|
|---|---|
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Blood and lymphatic system disorders
ANAEMIA
|
0.22%
5/2302 • Number of events 5
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.17%
4/2302 • Number of events 4
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.09%
2/2302 • Number of events 3
|
|
Cardiac disorders
PALPITATIONS
|
0.04%
1/2302 • Number of events 1
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.09%
2/2302 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.04%
1/2302 • Number of events 1
|
|
Gastrointestinal disorders
ASCITES
|
0.09%
2/2302 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.09%
2/2302 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA
|
0.22%
5/2302 • Number of events 5
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
ADVERSE EVENT
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
DEATH
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
ENANTHEMA
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
FATIGUE
|
0.22%
5/2302 • Number of events 5
|
|
General disorders
INJECTION SITE INFLAMMATION
|
0.09%
2/2302 • Number of events 2
|
|
General disorders
INJECTION SITE PRURITUS
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
MALAISE
|
0.04%
1/2302 • Number of events 1
|
|
General disorders
PYREXIA
|
0.09%
2/2302 • Number of events 2
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.09%
2/2302 • Number of events 2
|
|
Infections and infestations
HERPES ZOSTER OPHTHALMIC
|
0.04%
1/2302 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.09%
2/2302 • Number of events 2
|
|
Infections and infestations
SEPSIS
|
0.04%
1/2302 • Number of events 1
|
|
Infections and infestations
UROSEPSIS
|
0.04%
1/2302 • Number of events 1
|
|
Injury, poisoning and procedural complications
FALL
|
0.04%
1/2302 • Number of events 1
|
|
Investigations
BLOOD COUNT
|
0.04%
1/2302 • Number of events 1
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.09%
2/2302 • Number of events 2
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
0.04%
1/2302 • Number of events 1
|
|
Investigations
WEIGHT DECREASED
|
0.17%
4/2302 • Number of events 4
|
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Metabolism and nutrition disorders
ANOREXIA
|
0.04%
1/2302 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.04%
1/2302 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.04%
1/2302 • Number of events 1
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.04%
1/2302 • Number of events 1
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.04%
1/2302 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
0.04%
1/2302 • Number of events 1
|
|
Nervous system disorders
EPILEPSY
|
0.04%
1/2302 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
0.13%
3/2302 • Number of events 3
|
|
Nervous system disorders
HYPOTONIA
|
0.04%
1/2302 • Number of events 1
|
|
Nervous system disorders
SOMNOLENCE
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
AGGRESSION
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
DEPENDENCE
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.17%
4/2302 • Number of events 4
|
|
Psychiatric disorders
DEPRESSION
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
LISTLESS
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
MIDDLE INSOMNIA
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
MOOD SWINGS
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.04%
1/2302 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.04%
1/2302 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.04%
1/2302 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.04%
1/2302 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.04%
1/2302 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.04%
1/2302 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.04%
1/2302 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.04%
1/2302 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.04%
1/2302 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.04%
1/2302 • Number of events 1
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
0.04%
1/2302 • Number of events 1
|
Other adverse events
| Measure |
All Participants
n=2302 participants at risk
|
|---|---|
|
General disorders
FATIGUE
|
6.6%
151/2302 • Number of events 158
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All rights according to the results belong to Essex, Germany. Publications or transmission of data need a previous written agreement of the company.
- Publication restrictions are in place
Restriction type: OTHER