Clinical trial NCT00049842: Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
Official title: PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Liver Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-11-15
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: 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).
timeFrame: Baseline to up to Month-36
Secondary outcomes:
measure: Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)
timeFrame: Baseline to up to Month-36
measure: Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)
timeFrame: Baseline to up to Month-36
measure: The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline
timeFrame: Baseline to up to Month-36
measure: Mean Change in the METAVIR Activity Score (Using a Continuous Scale)
timeFrame: Baseline to up to Month-36
measure: Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.
timeFrame: Baseline to up to Month-36
Other outcomes:
Locations:
Study officials:
References:
citation: Poynard T, Bruix J, Schiff ER, Diago M, Berg T, Moreno-Otero R, Lyra AC, Carrilho F, Griffel LH, Boparai N, Jiang R, Burroughs M, Brass CA, Albrecht JK. Improved inflammatory activity with peginterferon alfa-2b maintenance therapy in non-cirrhotic prior non-responders: a randomized study. J Hepatol. 2013 Mar;58(3):452-9. doi: 10.1016/j.jhep.2012.11.001. Epub 2012 Nov 14.