Clinical trial NCT00823862: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: HCV
Immunostimulatory sequence (ISS)
TLR9 (toll-like receptor 9)
interferon (IFN)
ribavirin
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
name: PPD Development, LP
First posted: 2009-01-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Adverse event timing, duration, and severity.
timeFrame: Between doses and up to 3 months after last dose
Secondary outcomes:
measure: Biomarker analysis of blood sample
timeFrame: pre and 24 hour post dose
measure: Viral load in blood sample
timeFrame: each visit
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
city: Lublin
country: Poland
facility: Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
city: Warszawa
country: Poland
facility: Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
city: Warszawa
country: Poland
facility: Wojewódzki Szpital Zakaźny
city: Wrocław
country: Poland
facility: EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
Study officials:
affiliation: Warszawski Uniwersytet Medyczny
name: Janusz Cianciara, MD
role: PRINCIPAL_INVESTIGATOR
References: