Trial Outcomes & Findings for Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413) (NCT NCT00704964)
NCT ID: NCT00704964
Last Updated: 2015-10-06
Results Overview
Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
Recruitment status
COMPLETED
Target enrollment
746 participants
Primary outcome timeframe
Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
Results posted on
2015-10-06
Participant Flow
Participant milestones
| Measure |
All Participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
Completers are considered those with documentation who finished the study on time.
|
|---|---|
|
Overall Study
STARTED
|
746
|
|
Overall Study
COMPLETED
|
418
|
|
Overall Study
NOT COMPLETED
|
328
|
Reasons for withdrawal
| Measure |
All Participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
Completers are considered those with documentation who finished the study on time.
|
|---|---|
|
Overall Study
Not completed on time
|
328
|
Baseline Characteristics
Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)
Baseline characteristics by cohort
| Measure |
All Participants
n=746 Participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
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|---|---|
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Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.44 • n=93 Participants
|
|
Sex: Female, Male
Female
|
297 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
449 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
746 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
Outcome measures
| Measure |
All Participants
n=746 Participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
|
|---|---|
|
Number of Participants With Biometrical Adherence to Therapy
PegIntron + Rebetol
|
406 Participants
|
|
Number of Participants With Biometrical Adherence to Therapy
PegIntron
|
415 Participants
|
|
Number of Participants With Biometrical Adherence to Therapy
Rebetol
|
413 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3Adherence was based on physiciant's clinical judgment.
Outcome measures
| Measure |
All Participants
n=746 Participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
|
|---|---|
|
Number of Participants With Adherence to Therapy According to Physician Approximation
PegIntron
|
615 Participants
|
|
Number of Participants With Adherence to Therapy According to Physician Approximation
Rebetol
|
604 Participants
|
Adverse Events
All Participants
Serious events: 27 serious events
Other events: 332 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=746 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.13%
1/746 • Number of events 2
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.27%
2/746 • Number of events 2
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.13%
1/746 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.13%
1/746 • Number of events 1
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.13%
1/746 • Number of events 1
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.13%
1/746 • Number of events 1
|
|
General disorders
ADVERSE EVENT
|
0.27%
2/746 • Number of events 4
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.13%
1/746 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.13%
1/746 • Number of events 1
|
|
Infections and infestations
OSTEOMYELITIS
|
0.13%
1/746 • Number of events 1
|
|
Infections and infestations
TOXOPLASMOSIS
|
0.13%
1/746 • Number of events 1
|
|
Injury, poisoning and procedural complications
NARCOTIC INTOXICATION
|
0.13%
1/746 • Number of events 1
|
|
Investigations
WEIGHT DECREASED
|
0.13%
1/746 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
0.13%
1/746 • Number of events 1
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
AGGRESSION
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.13%
1/746 • Number of events 2
|
|
Psychiatric disorders
ALCOHOL PROBLEM
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
ANXIETY DISORDER
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
0.67%
5/746 • Number of events 7
|
|
Psychiatric disorders
MERYCISM
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
PSYCHIATRIC DECOMPENSATION
|
0.27%
2/746 • Number of events 2
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.40%
3/746 • Number of events 3
|
|
Psychiatric disorders
RESTLESSNESS
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.13%
1/746 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.13%
1/746 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.27%
2/746 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.13%
1/746 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.40%
3/746 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
SKIN BURNING SENSATION
|
0.13%
1/746 • Number of events 1
|
|
Surgical and medical procedures
APPENDICECTOMY
|
0.13%
1/746 • Number of events 1
|
Other adverse events
| Measure |
All Participants
n=746 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.2%
46/746 • Number of events 50
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.4%
40/746 • Number of events 42
|
|
Gastrointestinal disorders
NAUSEA
|
9.9%
74/746 • Number of events 80
|
|
General disorders
FATIGUE
|
14.1%
105/746 • Number of events 131
|
|
General disorders
IRRITABILITY
|
6.3%
47/746 • Number of events 47
|
|
General disorders
PYREXIA
|
5.9%
44/746 • Number of events 49
|
|
Infections and infestations
INFLUENZA
|
9.1%
68/746 • Number of events 71
|
|
Investigations
WEIGHT DECREASED
|
9.2%
69/746 • Number of events 77
|
|
Metabolism and nutrition disorders
ANOREXIA
|
9.1%
68/746 • Number of events 71
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.4%
55/746 • Number of events 56
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.6%
42/746 • Number of events 42
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
6.8%
51/746 • Number of events 53
|
|
Nervous system disorders
DIZZINESS
|
5.5%
41/746 • Number of events 41
|
|
Nervous system disorders
HEADACHE
|
11.5%
86/746 • Number of events 87
|
|
Psychiatric disorders
DEPRESSED MOOD
|
5.5%
41/746 • Number of events 44
|
|
Psychiatric disorders
DEPRESSION
|
7.0%
52/746 • Number of events 58
|
|
Psychiatric disorders
SLEEP DISORDER
|
10.2%
76/746 • Number of events 79
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.1%
38/746 • Number of events 40
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
8.4%
63/746 • Number of events 70
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.9%
59/746 • Number of events 59
|
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