Hepacivirus, Hepatitis C, Chronic
Conditions
Brief summary
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.
Interventions
BIOLOGICALPeginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
BEHAVIORALPatient assistance program
Assistance programs will be classified as follows: 1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) 2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with hepatitis C
Exclusion criteria
* According to the products' labeling (refer to Warnings, contraindications, and safety sections).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program | 24 or 48 weeks (depending on genotype) and 24 weeks of follow up |
| Average Length of Treatment With PegIntron/Rebetol | After start of treatment |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PegIntron Pen/Rebetol Without Patient Assistance Program PegIntron & Rebetol will be administered according to the products' labeling. | 481 |
| 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). | 120 |
| Total | 601 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 1 |
| Overall Study | Failure to appear again at hospital | 56 | 10 |
| Overall Study | Lack of Efficacy | 65 | 17 |
| Overall Study | No information on therapy end | 27 | 2 |
| Overall Study | Undefined causes | 9 | 7 |
| Overall Study | Withdrawal by Subject | 17 | 8 |
Baseline characteristics
| Characteristic | PegIntron Pen/Rebetol Without Patient Assistance Program | PegIntron Pen/Rebetol With Patient Assistance Program | Total |
|---|---|---|---|
| Age, Continuous | 41.85 years STANDARD_DEVIATION 12.98 | 41.38 years STANDARD_DEVIATION 11.96 | 41.76 years STANDARD_DEVIATION 12.77 |
| Region of Enrollment Austria | 481 participants | 120 participants | 601 participants |
| Sex: Female, Male Female | 175 Participants | 42 Participants | 217 Participants |
| Sex: Female, Male Male | 306 Participants | 78 Participants | 384 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 100 / 597 |
| serious Total, serious adverse events | 20 / 597 |
Outcome results
Primary
Average Length of Treatment With PegIntron/Rebetol
Time frame: After start of treatment
Population: Number of participants who received study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PegIntron Pen/Rebetol Without Patient Assistance Program | Average Length of Treatment With PegIntron/Rebetol | 28.8 Weeks | Standard Deviation 14.6 |
| PegIntron Pen/Rebetol With Patient Assistance Program | Average Length of Treatment With PegIntron/Rebetol | 27.3 Weeks | Standard Deviation 14.7 |
Primary
Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
Time frame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron Pen/Rebetol Without Patient Assistance Program | Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program | 298 Participants |
| PegIntron Pen/Rebetol With Patient Assistance Program | Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program | 75 Participants |