Trial Outcomes & Findings for Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED) (NCT NCT00704522)
NCT ID: NCT00704522
Last Updated: 2015-10-06
Results Overview
Recruitment status
COMPLETED
Target enrollment
601 participants
Primary outcome timeframe
24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Results posted on
2015-10-06
Participant Flow
Participant milestones
| Measure |
PegIntron Pen/Rebetol Without Patient Assistance Program
PegIntron \& Rebetol will be administered according to the products' labeling.
|
PegIntron Pen/Rebetol With Patient Assistance Program
PegIntron \& Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
|
|---|---|---|
|
Overall Study
STARTED
|
481
|
120
|
|
Overall Study
COMPLETED
|
298
|
75
|
|
Overall Study
NOT COMPLETED
|
183
|
45
|
Reasons for withdrawal
| Measure |
PegIntron Pen/Rebetol Without Patient Assistance Program
PegIntron \& Rebetol will be administered according to the products' labeling.
|
PegIntron Pen/Rebetol With Patient Assistance Program
PegIntron \& Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
65
|
17
|
|
Overall Study
Failure to appear again at hospital
|
56
|
10
|
|
Overall Study
Withdrawal by Subject
|
17
|
8
|
|
Overall Study
Adverse Event
|
9
|
1
|
|
Overall Study
Undefined causes
|
9
|
7
|
|
Overall Study
No information on therapy end
|
27
|
2
|
Baseline Characteristics
Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PegIntron Pen/Rebetol Without Patient Assistance Program
n=481 Participants
PegIntron \& Rebetol will be administered according to the products' labeling.
|
PegIntron Pen/Rebetol With Patient Assistance Program
n=120 Participants
PegIntron \& Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.85 years
STANDARD_DEVIATION 12.98 • n=5 Participants
|
41.38 years
STANDARD_DEVIATION 11.96 • n=7 Participants
|
41.76 years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
306 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
481 participants
n=5 Participants
|
120 participants
n=7 Participants
|
601 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 or 48 weeks (depending on genotype) and 24 weeks of follow upPopulation: All participants
Outcome measures
| Measure |
PegIntron Pen/Rebetol Without Patient Assistance Program
n=481 Participants
PegIntron \& Rebetol will be administered according to the products' labeling.
|
PegIntron Pen/Rebetol With Patient Assistance Program
n=120 Participants
PegIntron \& Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
|
|---|---|---|
|
Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
|
298 Participants
|
75 Participants
|
PRIMARY outcome
Timeframe: After start of treatmentPopulation: Number of participants who received study drug
Outcome measures
| Measure |
PegIntron Pen/Rebetol Without Patient Assistance Program
n=478 Participants
PegIntron \& Rebetol will be administered according to the products' labeling.
|
PegIntron Pen/Rebetol With Patient Assistance Program
n=119 Participants
PegIntron \& Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
|
|---|---|---|
|
Average Length of Treatment With PegIntron/Rebetol
|
28.8 Weeks
Standard Deviation 14.6
|
27.3 Weeks
Standard Deviation 14.7
|
Adverse Events
PegIntron Pen/Rebetol
Serious events: 20 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron Pen/Rebetol
n=597 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Gastrointestinal disorders
VOMITING
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
General disorders
INJECTION SITE REACTION
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Infections and infestations
ABSCESS SWEAT GLAND
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Infections and infestations
CELLULITIS
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Infections and infestations
ERYSIPELAS
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Infections and infestations
PNEUMONIA
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Infections and infestations
TUBERCULOSIS
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Infections and infestations
VIRAL INFECTION
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Investigations
SMEAR CERVIX ABNORMAL
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER IN SITU
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.34%
2/597 • Number of events 2
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Nervous system disorders
MYELOPATHY
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Renal and urinary disorders
RENAL COLIC
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.17%
1/597 • Number of events 1
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Surgical and medical procedures
HOSPITALISATION
|
0.34%
2/597 • Number of events 2
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
Other adverse events
| Measure |
PegIntron Pen/Rebetol
n=597 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.2%
49/597 • Number of events 50
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
7.2%
43/597 • Number of events 51
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
|
Psychiatric disorders
DEPRESSION
|
6.4%
38/597 • Number of events 38
Population for Adverse Event reporting is based on all participants who received study drug (N=597).
|
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