NCT01265511

Study of SCY-635, Pegasys and Copegus in Hepatitis C

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: The primary objective of this Phase 2a study was to assess the effect of treatment with SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive subjects with chronic genotype 1 infection who have an IL28B genotype of C/T or T/T. The secondary objective of the study was to evaluate the safety and pharmacokinetics (PK) of SCY-635 when given in combination with PegIFN α-2a and RBV. Primary Endpoints: Proportion of subjects in each cohort with an undetectable serum HCV RNA level at Week 4 of treatment Secondary Endpoints: Adverse events and clinical laboratory assessments, including tests of liver function Proportion of subjects achieving complete early virologic response (cEVR, defined as an undetectable serum HCV RNA level at Week 12) Proportion of subjects achieving partial early virologic response (pEVR, defined as a detectable serum HCV RNA level with ≥ 2 log10 reduction in serum HCV RNA from Baseline to Week 12) Proportion of subjects achieving an undetectable serum HCV RNA level at Week 24 Pharmacokinetic assessments of SCY-635 when given in combination with PegIFN α-2a and RBV; trough concentrations of PegIFN α-2a and RB

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Placebo	Oral tablets given bid for 28 days
DRUG	SCY-635	SCY-635 tablets, 300 mg bid for 28 days
DRUG	Pegasys	180 ug prefilled syringe given once per week for up to 48 weeks
DRUG	Copegus	tablets given bid for up to 48 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-12-23
• Last updated: 2017-08-18
• Results posted: 2017-08-18

Locations

4 sites across 2 countries: United States, Puerto Rico