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

NCT01265511 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-08-18

Study results available
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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.

Conditions

  • Hepatitis C Infection

Interventions

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

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew J Muir, MD · Duke Clinical Research Institute

  • Keyur Patel, MD · Duke Clinical Ressearch Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01265511 on ClinicalTrials.gov