Trial Outcomes & Findings for Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247) (NCT NCT00705107)

Last Updated: 2015-06-30

Results Overview

Recruitment status

TERMINATED

Target enrollment

267 participants

Primary outcome timeframe

Assessed at the end of the 48-week treatment.

Results posted on

2015-06-30

Withdrawal data not reported

Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)

Baseline characteristics by cohort
Measure	All Treated Patients n=267 Participants
Age, Continuous	51.35 years STANDARD_DEVIATION 10.11 • n=5 Participants
Sex/Gender, Customized Female	168 participants n=5 Participants
Sex/Gender, Customized Male	98 participants n=5 Participants
Sex/Gender, Customized Missing	1 participants n=5 Participants
Region of Enrollment Romania	267 participants n=5 Participants

Timeframe: Assessed at the end of the 48-week treatment.

Population: All participants

Outcome measures
Measure	All Treated Patients n=267 Participants
Number of Subjects Who Completed Treatment.	218 Participants

Timeframe: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.

Outcome measures
Measure	All Treated Patients n=267 Participants
Average Length of Treatment.	43.60 weeks Standard Deviation 21.38

Serious events: 1 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events
Measure	All Treated Patients n=267 participants at risk
General disorders Death	0.37% 1/267 • Number of events 1

Other adverse events
Measure	All Treated Patients n=267 participants at risk
Blood and lymphatic system disorders Anaemia	19.5% 52/267 • Number of events 148
Blood and lymphatic system disorders Leukopenia	10.5% 28/267 • Number of events 85
Blood and lymphatic system disorders Thrombocytopenia	6.4% 17/267 • Number of events 49
General disorders Asthenia	21.7% 58/267 • Number of events 163
General disorders Chills	5.6% 15/267 • Number of events 22
General disorders Influenza like illness	9.4% 25/267 • Number of events 62
General disorders Pyrexia	12.4% 33/267 • Number of events 60
Investigations Weight decreased	19.1% 51/267 • Number of events 86
Metabolism and nutrition disorders Decreased appetite	10.9% 29/267 • Number of events 68
Musculoskeletal and connective tissue disorders Myalgia	7.1% 19/267 • Number of events 30
Nervous system disorders Headache	9.4% 25/267 • Number of events 57
Psychiatric disorders Depression	6.7% 18/267 • Number of events 44
Nervous system disorders Insomnia	7.5% 20/267 • Number of events 48
Skin and subcutaneous tissue disorders Alopecia	5.2% 14/267 • Number of events 28

Merck Sharp & Dohme Corp.