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

Dynavax Technologies Corporation

Status and phase

Completed

Phase 1

Conditions

Chronic Hepatitis C

Treatments

Drug: ribavirin

Drug: SD-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823862

DV3-HCV-01

2008-001708-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.