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

NCT00823862 | Completed Phase 1

• 2 other identifiers: DV3-HCV-012008-001708-22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Hepatitis C

Keywords

HCV; Immunostimulatory sequence (ISS); TLR9 (toll-like receptor 9); interferon (IFN); ribavirin

Outcome Measures

Primary Outcomes (1)

• Adverse event timing, duration, and severity.

  Between doses and up to 3 months after last dose

Secondary Outcomes (2)

• Biomarker analysis of blood sample

  pre and 24 hour post dose

• Viral load in blood sample

  each visit

Study Arms (1)

Active (SD-101)

EXPERIMENTAL

SD-101 in cohorts of escalating doses

Drug: SD-101; Drug: ribavirin

Interventions

SD-101 DRUG

Intramuscular (IM)

Also known as: CpG Class C Immunostimulatory Sequence (ISS), TLR9 Agonist

Active (SD-101)

ribavirin DRUG

oral, 2 times per day, for 2 months

Active (SD-101)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead
• Synteract, Inc.: collaborator
• PPD Development, LP: collaborator

Study Sites (5)

Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika

Bydgoszcz, 85 - 030, Poland

Location

Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie

Lublin, 20-089, Poland

Location

Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych

Warsaw, 01-201, Poland

Location

Wojewódzki Szpital Zakaźny

Warsaw, 01-201, Poland

Location

EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"

Wroclaw, 144-148, Poland

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Janusz Cianciara, MD

  Warszawski Uniwersytet Medyczny

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

PL (5)