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.

Sponsor:

Collaborators:

Synteract, Inc.

PPD

Information provided by:

Dynavax Technologies Corporation

ClinicalTrials.gov Identifier:

NCT00823862

First received: January 14, 2009

Last updated: February 9, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

January 14, 2009

Last Updated Date

February 9, 2010

Start Date ^ICMJE

October 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00823862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Drug: SD-101
IM
Other Names:
- CpG Class C Immunostimulatory Sequence (ISS)
- TLR9 Agonist
Drug: ribavirin
oral, 2 times per day, for 2 months

Study Arm (s)

Experimental: Active (SD-101)

SD-101 in cohorts of escalating doses

Interventions:

Drug: SD-101
Drug: ribavirin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00823862

Other Study ID Numbers ^ICMJE

DV3-HCV-01, EudraCT: 2008-001708-22

Has Data Monitoring Committee

Responsible Party

J. Tyler Martin / Chief Medical Officer, Dynavax Technologies Corporation

Study Sponsor ^ICMJE

Dynavax Technologies Corporation

Collaborators ^ICMJE

Synteract, Inc.
PPD

Investigators ^ICMJE

Principal Investigator:

Janusz Cianciara, MD

Warszawski Uniwersytet Medyczny

Information Provided By

Dynavax Technologies Corporation

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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