Hepatitis C, Chronic Clinical Trial
Official title:
480 STUDY: Phase 2b Open-label, Randomized Study in Treatment Naïve Subjects With HCV G1 to Compare the Efficacy, Safety, and Tolerability of the 480 µg Dose of Locteron™ Plus Ribavirin Given Bi-Weekly to PEG-Intron™ Plus Ribavirin Given Weekly
The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly.
The aim of the 480 STUDY was to compare efficacy and safety of 480ug Locteron dosed every
other week to 1.5 ug/kg PegIntron dosed weekly in treatment-naïve genotype-1 chronic HCV
subjects treated with weight-based ribavirin. This 12-week study was comprised of two panels
(Panel A and Panel B). The designs of both panels were identical. HCV RNA was measured
weekly for three weeks and then every other week. Adverse events including flu-like events
and depression were collected during weekly clinic visits for 12 weeks. Flu-like events were
also collected daily for 12 weeks by subject self-report using the internet (ePRO). Beck
Depression Inventory (BDI) and Short Form-36 scores were measured at baseline and monthly
through Week 12.
In Panel A of 480 STUDY, 42 treatment-naïve subjects with chronic genotype-1 HCV in Bulgaria
and Romania were randomized and dosed with either Locteron q2weeks or weekly PegIntron, both
in combination with weight-based ribavirin (13). In Panel A, 19 subjects received 480ug
Locteron and 23 subjects received PegIntron.
In Panel B of 480 STUDY, 32 treatment-naïve subjects with genotype-1 HCV in Israel were
randomized and dosed with either Locteron q2weeks or weekly PegIntron, both in combination
with weight-based ribavirin (13). In Panel B, 16 subjects received 480ug Locteron and 16
subjects received PegIntron.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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