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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00823862•Dynavax Technologies Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

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
+2 more criteria

Locations (5)

Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika

Bydgoszcz, Poland

Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie

Lublin, Poland

Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych

Warsaw, Poland

Wojewódzki Szpital Zakaźny

Warsaw, Poland

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

Wroclaw, Poland

Key Dates

Start Date

October 1, 2008

Primary Completion Date

December 1, 2009

Completion Date

February 1, 2010

Last Updated

April 16, 2019

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

SD-101

DRUG

ribavirin

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

View study

COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

View study

COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection