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

Sponsor

Dynavax Technologies Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00823862

Collaborator

Synteract, Inc. (Industry), PPD (Industry)

Enrollment

Locations

Arm

Duration (Months)

6.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: SD-101 Drug: ribavirin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active (SD-101) SD-101 in cohorts of escalating doses	Drug: SD-101 Intramuscular (IM) Other Names: CpG Class C Immunostimulatory Sequence (ISS) TLR9 Agonist Drug: ribavirin oral, 2 times per day, for 2 months

Arm

Intervention/Treatment

Experimental: Active (SD-101)

SD-101 in cohorts of escalating doses

Drug: SD-101

Intramuscular (IM)

Other Names:

CpG Class C Immunostimulatory Sequence (ISS)

TLR9 Agonist

Drug: ribavirin

oral, 2 times per day, for 2 months

Outcome Measures

Primary Outcome Measures

Adverse event timing, duration, and severity. [Between doses and up to 3 months after last dose]

Secondary Outcome Measures

Biomarker analysis of blood sample [pre and 24 hour post dose]
Viral load in blood sample [each visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika	Bydgoszcz	Poland	85 - 030
2	Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie	Lublin	Poland	20-089
3	Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych	Warszawa	Poland	01-201
4	Wojewódzki Szpital Zakaźny	Warszawa	Poland	01-201
5	EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"	Wrocław	Poland	144-148