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

Dynavax Technologies Corporation5 sites in 1 country34 target enrollmentOctober 2008

ConditionsChronic Hepatitis C

Interventionsribavirin SD-101

DrugsSD-101 ribavirin

Overview

Phase: Phase 1
Intervention: ribavirin
Conditions: Chronic Hepatitis C
Sponsor: Dynavax Technologies Corporation
Enrollment: 34
Locations: 5
Primary Endpoint: Adverse event timing, duration, and severity.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

February 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dynavax Technologies Corporation

Responsible Party

Sponsor

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
•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