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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823862
• Other study ID #: DV3-HCV-01
• Secondary ID: 2008-001708-22
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: April 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• SD-101
Intramuscular (IM)
• ribavirin
oral, 2 times per day, for 2 months

Locations

Country	Name	City	State
Poland	Klinika Chorób Zakaznych i Hepatologii Collegium Medicum Uniwersytet Mikolaja Kopernika	Bydgoszcz
Poland	Katedra i Klinika Chorób Zakaznych Uniwersytet Medyczny w Lublinie	Lublin
Poland	Wojewódzki Szpital Zakazny	Warszawa
Poland	Wojewódzki Szpital Zakazny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych	Warszawa
Poland	EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnia "EuroMediCare"	Wroclaw

Sponsors (3)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation	PPD, Synteract, Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event timing, duration, and severity.		Between doses and up to 3 months after last dose
Secondary	Biomarker analysis of blood sample		pre and 24 hour post dose
Secondary	Viral load in blood sample		each visit