Status:
COMPLETED
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
Lead Sponsor:
Dynavax Technologies Corporation
Collaborating Sponsors:
Synteract, Inc.
PPD Development, LP
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00823862
Start Date
October 1 2008
End Date
February 1 2010
Last Update
April 16 2019
Active Locations (5)
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1
Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
Bydgoszcz, Poland, 85 - 030
2
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
Lublin, Poland, 20-089
3
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
Warsaw, Poland, 01-201
4
Wojewódzki Szpital Zakaźny
Warsaw, Poland, 01-201