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Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

NCT00823862 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-04-16

No results posted yet for this study

Summary

To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

SD-101

Intramuscular (IM)

DRUG

ribavirin

oral, 2 times per day, for 2 months

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Janusz Cianciara, MD · Warszawski Uniwersytet Medyczny

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • Poland

Study Locations

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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 NCT00823862 on ClinicalTrials.gov