Safety Study of SD-101 (a Novel C Type 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:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00823862
First received: January 14, 2009
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: SD-101
Drug: ribavirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Adverse event timing, duration, and severity. [ Time Frame: Between doses and up to 3 months after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active (SD-101)
SD-101 in cohorts of escalating doses
Drug: SD-101
IM
Other Names:
  • CpG Class C Immunostimulatory Sequence (ISS)
  • TLR9 Agonist
Drug: ribavirin
oral, 2 times per day, for 2 months

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823862

Locations
Poland
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.
PPD
Investigators
Principal Investigator: Janusz Cianciara, MD Warszawski Uniwersytet Medyczny
  More Information

No publications provided

Responsible Party: J. Tyler Martin / Chief Medical Officer, Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00823862     History of Changes
Other Study ID Numbers: DV3-HCV-01, EudraCT: 2008-001708-22
Study First Received: January 14, 2009
Last Updated: February 9, 2010
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

Keywords provided by Dynavax Technologies Corporation:
HCV
ISS
TLR9
interferon
ribavirin

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

ClinicalTrials.gov processed this record on April 22, 2014