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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

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
  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
Intramuscular (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Warszawa, Poland, 01-201
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
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: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00823862     History of Changes
Other Study ID Numbers: DV3-HCV-01, 2008-001708-22
Study First Received: January 14, 2009
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014