At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a Study of SCY-635 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Hepatitis C Infection
In Brief
A Phase 2 clinical trial evaluating Placebo, SCY-635, and 2 other interventions for Hepatitis C Infection. Completed, enrolled 10 participants across 4 sites in 2 countries.
Detailed Summary
This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. The Week 24 visit will be the last on-study visit. After the Week 24 visit, all subjects with undetectable HCV RNA will be given the option to continue treatment with standard of care for an additional 24 weeks (out to Week 48) under the care of their Principal Investigator.
Study Details
Timeline
Interventions
Oral tablets given bid for 28 days
SCY-635 tablets, 300 mg bid for 28 days
180 ug prefilled syringe given once per week for up to 48 weeks
tablets given bid for up to 48 weeks