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

This study has been completed.

First Received: January 14, 2009 Last Updated: February 9, 2010 History of Changes

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:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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 ]

Enrollment:	34
Study Start Date:	October 2008
Study Completion Date:	February 2010
Primary Completion Date:	December 2009 (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
Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
Bydgoszcz, Poland, 85 - 030
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
Lublin, Poland, 20-089
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
Warszawa, Poland, 01-201
Wojewódzki Szpital Zakaźny
Warszawa, Poland, 01-201
EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
Wrocław, Poland, 144-148

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 ( J. Tyler Martin / Chief Medical Officer )
ClinicalTrials.gov Identifier:	NCT00823862 History of Changes
Other Study ID Numbers:	DV3-HCV-01, EudraCT: 2008-001708-22
Study First Received:	January 14, 2009
Last Updated:	February 9, 2010
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:

Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections

RNA Virus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2010