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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: SD-101; Drug: ribavirin

• Registration Number: NCT00823862
• Lead Sponsor: Dynavax Technologies Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-16
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active (SD-101)	SD-101	SD-101 in cohorts of escalating doses
Active (SD-101)	ribavirin	SD-101 in cohorts of escalating doses

Primary Outcome Measures

Name	Time	Method
Adverse event timing, duration, and severity.	Between doses and up to 3 months after last dose

Secondary Outcome Measures

Name	Time	Method
Viral load in blood sample	each visit
Biomarker analysis of blood sample	pre and 24 hour post dose

Trial Locations

Locations (5)

Wojewódzki Szpital Zakaźny; 🇵🇱 Warszawa, Poland

EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"; 🇵🇱 Wrocław, Poland

Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika; 🇵🇱 Bydgoszcz, Poland

Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie; 🇵🇱 Lublin, Poland

Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych; 🇵🇱 Warszawa, Poland