Phase 3
Completed N=540
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
Chronic Hepatitis C · Liver Fibrosis
Source: ClinicalTrials.gov NCT00049842 ↗
Enrolled (actual)
540
Serious AEs
15.6%
Results posted
Jan 2011
Primary outcomePrimary: Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). — 44; 29; 162; 176 Participants
Summary
The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). |
44; 29; 162; 176; 64; 65 | — |
| SECONDARY Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) |
54; 23; 195; 209; 21; 38 | — |
| SECONDARY Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) |
0.13; 0.31 | — |
| SECONDARY The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline |
206; 205; 64; 65 | — |
| SECONDARY Mean Change in the METAVIR Activity Score (Using a Continuous Scale) |
-0.20; 0.11 | — |
| SECONDARY Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. |
249; 232; 21; 38 | — |
Eligibility Criteria
Inclusion Criteria
- Age at entry in study P02370 (NCT00039871) 18-65 years;
- Nonresponder to PEG-Intron plus Rebetol in study P02370
Exclusion Criteria
- Participants who did not participate in the P02370 study.
- Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.
Data sourced from ClinicalTrials.gov (NCT00049842). 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.