Hepatitis C, Chronic
Conditions
Brief summary
Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.
Detailed description
The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Pegintron approval.
Interventions
BIOLOGICALPeginterferon alfa-2b (SCH 54031)
Surveillance will be conducted after administration of peginterferon alfa-2b (administered according to the directions on the products' labeling). PegIntron Injection for surveillance is a weight-based dosing product administered at a dose of 0.5/1.0 ug/kg or 1.5 ug/kg. Administration of treatment is not part of this study.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with chronic hepatitis C treated with peginterferon alfa-2b. Signed written contract.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Reported a Serious Adverse Event | 24 weeks after administration of PegIntron Injection | Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported. |
| Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold | 24 weeks after administration of PegIntron Injection. | Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegintron/Pegintron Redipen Injection Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label. | 1,267 |
| Total | 1,267 |
Baseline characteristics
| Characteristic | Pegintron/Pegintron Redipen Injection |
|---|---|
| Age, Customized Between 16 and 80 years | 1267 participants |
| Sex: Female, Male Female | 585 Participants |
| Sex: Female, Male Male | 682 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 820 / 1,267 |
| serious Total, serious adverse events | 15 / 1,267 |
Outcome results
Primary
Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold
Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.
Time frame: 24 weeks after administration of PegIntron Injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegintron/Pegintron Redipen Injection | Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold | 820 Participants |
Primary
Number of Participants That Reported a Serious Adverse Event
Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.
Time frame: 24 weeks after administration of PegIntron Injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegintron/Pegintron Redipen Injection | Number of Participants That Reported a Serious Adverse Event | 15 Participants |