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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823862
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : March 1, 2018
Synteract, Inc.
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: SD-101 Drug: ribavirin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active (SD-101)
SD-101 in cohorts of escalating doses
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

Primary Outcome Measures :
  1. Adverse event timing, duration, and severity. [ Time Frame: Between doses and up to 3 months after last dose ]

Secondary Outcome Measures :
  1. Biomarker analysis of blood sample [ Time Frame: pre and 24 hour post dose ]
  2. Viral load in blood sample [ Time Frame: each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823862

Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
Bydgoszcz, Poland, 85 - 030
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
Lublin, Poland, 20-089
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
Warszawa, Poland, 01-201
Wojewódzki Szpital Zakaźny
Warszawa, Poland, 01-201
EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
Wrocław, Poland, 144-148
Sponsors and Collaborators
Dynavax Technologies Corporation
Synteract, Inc.
Principal Investigator: Janusz Cianciara, MD Warszawski Uniwersytet Medyczny

Responsible Party: Dynavax Technologies Corporation Identifier: NCT00823862     History of Changes
Other Study ID Numbers: DV3-HCV-01
2008-001708-22 ( EudraCT Number )
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 3/2017 no change to status in this Phase 1 study

Keywords provided by Dynavax Technologies Corporation:
Immunostimulatory sequence (ISS)
TLR9 (toll-like receptor 9)
interferon (IFN)

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents