Back to resultsSafety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
SD-101
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, Immunostimulatory sequence (ISS), TLR9 (toll-like receptor 9), interferon (IFN), ribavirin
Eligibility 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.
Sites / Locations
- Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
- Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
- Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
- Wojewódzki Szpital Zakaźny
- EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active (SD-101)
Arm Description
SD-101 in cohorts of escalating doses
Outcomes
Primary Outcome Measures
Adverse event timing, duration, and severity.
Secondary Outcome Measures
Biomarker analysis of blood sample
Viral load in blood sample
Full Information
NCT ID
NCT00823862
First Posted
January 14, 2009
Last Updated
April 11, 2019
Sponsor
Dynavax Technologies Corporation
Collaborators
Synteract, Inc., PPD
1. Study Identification
Unique Protocol Identification Number
NCT00823862
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation
Collaborators
Synteract, Inc., PPD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV, Immunostimulatory sequence (ISS), TLR9 (toll-like receptor 9), interferon (IFN), ribavirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active (SD-101)
Arm Type
Experimental
Arm Description
SD-101 in cohorts of escalating doses
Intervention Type
Drug
Intervention Name(s)
SD-101
Other Intervention Name(s)
CpG Class C Immunostimulatory Sequence (ISS), TLR9 Agonist
Intervention Description
Intramuscular (IM)
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
oral, 2 times per day, for 2 months
Primary Outcome Measure Information:
Title
Adverse event timing, duration, and severity.
Time Frame
Between doses and up to 3 months after last dose
Secondary Outcome Measure Information:
Title
Biomarker analysis of blood sample
Time Frame
pre and 24 hour post dose
Title
Viral load in blood sample
Time Frame
each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janusz Cianciara, MD
Organizational Affiliation
Warszawski Uniwersytet Medyczny
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
City
Bydgoszcz
ZIP/Postal Code
85 - 030
Country
Poland
Facility Name
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
City
Lublin
ZIP/Postal Code
20-089
Country
Poland
Facility Name
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Wojewódzki Szpital Zakaźny
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
City
Wrocław
ZIP/Postal Code
144-148
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
3/2017 no change to status in this Phase 1 study
Learn more about this trial
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
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