Safety Study of SD-101 (a Novel C Type TLR9 Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

This study is currently recruiting participants.

Verified by Dynavax Technologies Corporation, January 2009

First Received: January 14, 2009 No Changes Posted

Sponsor:	Dynavax Technologies Corporation
Collaborators:	Synteract, INC PPD
Information provided by:	Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:	NCT00823862

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: SD-101 Drug: ribavirin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin

U.S. FDA Resources

Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:

Adverse event timing, duration, and severity. [ Time Frame: Between doses and up to 3 months after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biomarker analysis of blood sample [ Time Frame: pre and 24 hour post dose ] [ Designated as safety issue: No ]
Viral load in blood sample [ Time Frame: each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active (SD-101): Experimental SD-101 in cohorts of escalating doses	Drug: SD-101 IM Drug: ribavirin oral, 2 times per day, for 2 months

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823862

Locations

Poland
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych	Recruiting
Warszawa, Poland, 01-201
Contact: Joanna Jabłońska, MD 48 22 335 53 08 joannaj108@hotmail.com
Principal Investigator: Janusz Cianciara, MD
Wojewódzki Szpital Zakaźny	Recruiting
Warszawa, Poland, 01-201
Contact: Hanna Berak, MD 48-22-335-52-80 hberak@zakazny.pl
Principal Investigator: Andrzej Horban, MD
Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika	Recruiting
Bydgoszcz, Poland, 85 - 030
Contact: Dorota Dybowska, MD 48-52-325-56-71 d.dybowska@wsoz.pl
Principal Investigator: Waldemar Halota, MD
EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"	Recruiting
Wrocław, Poland, 144-148
Contact: Marcin Czarnecki, MD 48-71-326-13-27 to 31 ext 235, 236 czarnecki.medyk@wp.pl
Principal Investigator: Andrzej Gładysz, MD
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie	Recruiting
Lublin, Poland, 20-089
Contact: Krzysztof Tomasiewicz, MD 48 602 365 317 tomaskdr@tlen.pl
Principal Investigator: Romana Modrzewska, MD

Sponsors and Collaborators

Dynavax Technologies Corporation

Synteract, INC

PPD

Investigators

Principal Investigator:

Janusz Cianciara, MD

Warszawski Uniwersytet Medyczny

More Information

No publications provided

Responsible Party:	Dynavax Technologies Corporation ( Maggie Neptune / Senior Director, Clinical Operations )
Study ID Numbers:	DV3-HCV-01, EudraCT: 2008-001708-22
Study First Received:	January 14, 2009
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00823862 History of Changes
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health

Keywords provided by Dynavax Technologies Corporation:

HCV
ISS
TLR9
interferon
ribavirin

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Ribavirin
Hepatitis, Viral, Human

Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 20, 2009