Clinical Trial: A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Open-label, Intra-individual Controlled, Single-center Study to Investigate the Efficacy, Safety and Tolerability of a Polyethylene Glycol-formulation and the Viral Shedding in Patients Suf

Brief Summary: The aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.

Detailed Summary:
Sponsor: Devirex AG

Current Primary Outcome: Change of number of genital herpes recurrences during the treatment period as compared to the baseline period. [ Time Frame: Baseline and Treatment period (6 months each). ]

The number of genital herpes recurrences will be counted during the baseline period (6 months) and during the treatment period (6 months) and then be compared.


Original Primary Outcome: Same as current

Current Secondary Outcome: The safety of the PEG-formulation via reporting of AEs. [ Time Frame: Baseline and Treatment period (6 months each). ]

Original Secondary Outcome: Same as current

Information By: Devirex AG

Dates:
Date Received: December 14, 2012
Date Started: February 2013
Date Completion:
Last Updated: August 4, 2014
Last Verified: August 2014