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

April 11, 2019 updated by: Dynavax Technologies Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85 - 030
        • Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
      • Lublin, Poland, 20-089
        • Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
      • Warszawa, Poland, 01-201
        • Wojewodzki Szpital Zakazny
      • Warszawa, Poland, 01-201
        • Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
      • Wrocław, Poland, 144-148
        • EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event timing, duration, and severity.
Time Frame: Between doses and up to 3 months after last dose
Between doses and up to 3 months after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Biomarker analysis of blood sample
Time Frame: pre and 24 hour post dose
pre and 24 hour post dose
Viral load in blood sample
Time Frame: each visit
each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynavax Technologies Corporation

Collaborators

PPD
Synteract, Inc.

Investigators

  • Principal Investigator: Janusz Cianciara, MD, Warszawski Uniwersytet Medyczny

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV3-HCV-01
  • 2008-001708-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

3/2017 no change to status in this Phase 1 study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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