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| Sponsor: | Epiphany Biosciences |
|---|---|
| Information provided by: | Epiphany Biosciences |
| ClinicalTrials.gov Identifier: | NCT00831103 |
Purpose
The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Zoster Antiviral Agents Anti-Infective Agents |
Drug: EPB-348 Drug: Valacyclovir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Active-Controlled, Multi-Center, Parallel-Group Dose-Ranging Study Assessing the Safety and Efficacy of EPB-348 Versus Valacyclovir Among Immunocompetent Patients With an Acute Episode of Herpes Zoster |
| Estimated Enrollment: | 375 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EPB-348 1000 mg
EPB-348 1000 mg dosed once daily for seven days
|
Drug: EPB-348
Treated over seven days
|
|
Experimental: EPB-348 2000 mg
EPB-348 2000 mg dosed once daily for seven days
|
Drug: EPB-348
Treated over seven days
|
|
Active Comparator: Valacyclovir
Valacyclovir 1000 mg dosed three times daily for seven days
|
Drug: Valacyclovir
Treated over seven days
|
In cells infected with varicella-zoster virus, there is evidence to suggest that EPB-348 could offer clinically important advantages in the treatment of acute herpes zoster over currently available therapies due to rapid absorption and conversion to the active moiety as well as a longer intra-cellular half-life in infected cells. Clinically, these characteristics could translate into once-daily dosing versus thrice-daily dosing as seen with current therapy, leading to a higher rate of compliance and quality-of-life, especially among elderly patients. The objective of EPB348-0201 is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster. This multi-center study will randomly assign patients to either EPB-348 1000 mg once daily or EPB-348 2000 mg once daily or valacyclovir 1000 mg three times daily.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Liz Mead, BSc | 610-989-4225 | emead@encorium.com |
| United States, Texas | |
| Center for Clinical Studies-Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Cruz Leonida 281-335-4605 lcruz@cctexas.com | |
| Principal Investigator: Stephen Tyring, M.D. | |
| Study Director: | Brian Murphy, M.D. | Epiphany Biosciences |
More Information
| Responsible Party: | Brian Murphy, M.D./ Chief Medical Officer, Epiphany Biosciences |
| ClinicalTrials.gov Identifier: | NCT00831103 History of Changes |
| Other Study ID Numbers: | EPB348-0201 |
| Study First Received: | January 26, 2009 |
| Last Updated: | January 26, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
EPB348 Valacyclovir Herpes Zoster |
|
Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases Valacyclovir |
Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |