Trial Outcomes & Findings for Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252) (NCT NCT00723892)
NCT ID: NCT00723892
Last Updated: 2015-10-30
Results Overview
Recruitment status
COMPLETED
Target enrollment
614 participants
Primary outcome timeframe
12 months after onset of treatment
Results posted on
2015-10-30
Participant Flow
614 participants were recruited in this study.
Only 568 participants were assigned to treatment as they were foreseen to complete treatment, were consulted, and met inclusion criteria.
Participant milestones
| Measure |
PegIntron/Rebetol and Psychotherapy Support Program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
PegIntron/Rebetol Alone (no Psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
|---|---|---|
|
Overall Study
STARTED
|
313
|
255
|
|
Overall Study
COMPLETED
|
206
|
168
|
|
Overall Study
NOT COMPLETED
|
107
|
87
|
Reasons for withdrawal
| Measure |
PegIntron/Rebetol and Psychotherapy Support Program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
PegIntron/Rebetol Alone (no Psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
|---|---|---|
|
Overall Study
Participant not tracked
|
33
|
35
|
|
Overall Study
Virological criterion
|
24
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
End planned
|
11
|
7
|
|
Overall Study
Bad tolerance
|
5
|
5
|
|
Overall Study
Multiple reasons
|
17
|
12
|
|
Overall Study
Other
|
6
|
3
|
|
Overall Study
Study end
|
1
|
3
|
|
Overall Study
Weight loss
|
1
|
3
|
|
Overall Study
Alcohol abuse
|
0
|
1
|
|
Overall Study
Intercurrent infection
|
2
|
0
|
|
Overall Study
Drug addiction
|
1
|
0
|
Baseline Characteristics
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Baseline characteristics by cohort
| Measure |
PegIntron/Rebetol and Psychotherapy Support Program
n=313 Participants
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
PegIntron/Rebetol Alone (no Psychotherapy)
n=255 Participants
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
Total
n=568 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
117 participants
n=5 Participants
|
80 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
195 participants
n=5 Participants
|
175 participants
n=7 Participants
|
370 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unavailable (missing data)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
313 participants
n=5 Participants
|
255 participants
n=7 Participants
|
568 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after onset of treatmentPopulation: Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.
Outcome measures
| Measure |
PegIntron/Rebetol and Psychotherapy Support Program
n=313 Participants
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
PegIntron/Rebetol Alone (no Psychotherapy)
n=255 Participants
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
|---|---|---|
|
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
|
206 Participants
|
168 Participants
|
SECONDARY outcome
Timeframe: 12 months after onset of treatmentPopulation: Participants with no missing results.
Outcome measures
| Measure |
PegIntron/Rebetol and Psychotherapy Support Program
n=306 Participants
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
PegIntron/Rebetol Alone (no Psychotherapy)
n=252 Participants
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
|---|---|---|
|
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
|
36.1 Weeks
Standard Deviation 16.2
|
35.3 Weeks
Standard Deviation 17.3
|
Adverse Events
All Enrolled Participants
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Enrolled Participants
n=614 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Cardiac disorders
Myocardial Infarction
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Endocrine disorders
Basedow's Disease
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
General disorders
Drug Intolerance
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.16%
1/614 • Number of events 2
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Psychiatric disorders
Persecutory Delusion
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.16%
1/614 • Number of events 1
Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800--672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Data publishing of the observational study is forbidden. Data and results of the observational study are the exclusive property of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER