N/A
Completed N=516
A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01659567 ↗
Enrolled (actual)
516
Serious AEs
3.3%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response (SVR) — 79.1 percentage of participants
Summary
This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response (SVR) |
79.1 | — |
| PRIMARY Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR |
93.1 | — |
| PRIMARY PPV of Complete Early Viral Response (cEVR) on SVR |
60.3 | — |
| SECONDARY Odds Ratio (OR) for Impact of Age on SVR |
0.21 | — |
| SECONDARY OR for Impact of Gender on SVR |
0.48 | — |
| SECONDARY OR for Impact of Body Weight on SVR |
1.01 | — |
| SECONDARY OR for Impact of Baseline Level of Fibrosis (kPa) on SVR |
0.53 | — |
| SECONDARY OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR |
0.12 | — |
| SECONDARY OR for Impact of Baseline Viral Load Count on SVR |
1.07 | — |
| SECONDARY OR for Impact of Overall Duration of Treatment on SVR |
1.05 | — |
| SECONDARY OR for Impact of Duration of Treatment After Achieving RVR on SVR |
1.04 | — |
| SECONDARY OR for Impact of Duration of Treatment After Achieving cEVR on SVR |
2.77 | — |
| SECONDARY OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR |
0.99 | — |
| SECONDARY OR for Impact of Cumulative Doses of Ribavirin on SVR |
0.99 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic hepatitis C infection
Exclusion Criteria
- Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
- Participants previously treated with pegylated interferon alfa-2a/ribavirin
- Participation in another clinical study within 30 days prior to study start of ML25544
Data sourced from ClinicalTrials.gov (NCT01659567). 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.