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

This study has been completed.
Sponsor:
Collaborators:
Synteract, Inc.
PPD
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00823862
First received: January 14, 2009
Last updated: June 16, 2014
Last verified: June 2014

January 14, 2009
June 16, 2014
October 2008
December 2009   (final data collection date for primary outcome measure)
Adverse event timing, duration, and severity. [ Time Frame: Between doses and up to 3 months after last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00823862 on ClinicalTrials.gov Archive Site
  • Biomarker analysis of blood sample [ Time Frame: pre and 24 hour post dose ] [ Designated as safety issue: No ]
  • Viral load in blood sample [ Time Frame: each visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: SD-101
    Intramuscular (IM)
    Other Names:
    • CpG Class C Immunostimulatory Sequence (ISS)
    • TLR9 Agonist
  • Drug: ribavirin
    oral, 2 times per day, for 2 months
Experimental: Active (SD-101)
SD-101 in cohorts of escalating doses
Interventions:
  • Drug: SD-101
  • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed, written, informed consent
  • Male or female subjects, 18 to 55 years of age.
  • Subject must have chronic infection HCV, genotype 1.
  • Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL
  • No prior treatment for HCV.
  • Must be negative for hepatitis B (HBV) and human immunodeficiency virus (HIV).
  • Must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study.
  • No known hypersensitivity to study medication or to drugs chemically related to the study.

Exclusion Criteria:

  • Prior treatment with IFN-based therapies and/or anti-viral therapies.
  • Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant.
  • Reduced kidney function.
  • Presence of concomitant liver diseases
  • Signs or symptoms of hepatocellular carcinoma.
  • Thyroid disease currently poorly controlled on prescribed medications.
  • History of hemoglobinopathy.
  • Evidence of severe retinopathy.
  • Other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse.
  • Subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease
  • Clinically significant acute or chronic illnesses.
  • History of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00823862
DV3-HCV-01, 2008-001708-22
No
Dynavax Technologies Corporation
Dynavax Technologies Corporation
  • Synteract, Inc.
  • PPD
Principal Investigator: Janusz Cianciara, MD Warszawski Uniwersytet Medyczny
Dynavax Technologies Corporation
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP