N/A
Completed N=1,267
PegIntron Injection Surveillance Plan (Study P04123)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00723931 ↗
Enrolled (actual)
1,267
Serious AEs
1.2%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants That Reported a Serious Adverse Event — 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Reported a Serious Adverse Event |
15 | — |
| PRIMARY Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold |
820 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with chronic hepatitis C treated with peginterferon alfa-2b.
Signed written contract.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00723931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.