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| 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: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | January 2010 (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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Poland | |
| Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych | Recruiting |
| Warszawa, Poland, 01-201 | |
| Contact: Joanna Jabłońska, MD 48 22 335 53 08 joannaj108@hotmail.com | |
| Principal Investigator: Janusz Cianciara, MD | |
| Wojewódzki Szpital Zakaźny | Recruiting |
| Warszawa, Poland, 01-201 | |
| Contact: Hanna Berak, MD 48-22-335-52-80 hberak@zakazny.pl | |
| Principal Investigator: Andrzej Horban, MD | |
| Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika | Recruiting |
| Bydgoszcz, Poland, 85 - 030 | |
| Contact: Dorota Dybowska, MD 48-52-325-56-71 d.dybowska@wsoz.pl | |
| Principal Investigator: Waldemar Halota, MD | |
| EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare" | Recruiting |
| Wrocław, Poland, 144-148 | |
| Contact: Marcin Czarnecki, MD 48-71-326-13-27 to 31 ext 235, 236 czarnecki.medyk@wp.pl | |
| Principal Investigator: Andrzej Gładysz, MD | |
| Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie | Recruiting |
| Lublin, Poland, 20-089 | |
| Contact: Krzysztof Tomasiewicz, MD 48 602 365 317 tomaskdr@tlen.pl | |
| Principal Investigator: Romana Modrzewska, MD | |
| Principal Investigator: | Janusz Cianciara, MD | Warszawski Uniwersytet Medyczny |
More Information
| Responsible Party: | Dynavax Technologies Corporation ( Maggie Neptune / Senior Director, Clinical Operations ) |
| Study ID Numbers: | DV3-HCV-01, EudraCT: 2008-001708-22 |
| Study First Received: | January 14, 2009 |
| Last Updated: | January 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00823862 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Poland: Ministry of Health |
|
HCV ISS TLR9 interferon ribavirin |
|
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Hepatitis, Chronic Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Ribavirin Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Hepatitis C Hepatitis C, Chronic |