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

August 4, 2014 updated by: Devirex AG

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 Suffering From Genital Herpes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent
  • 18 - 65 years
  • Positive for HSV-1 and/or -2 (as determined by serology testing in course of study)
  • Initial infection > 1 year ago
  • ≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy)
  • ≥ 2 recurrences during the six-month baseline period

Exclusion Criteria:

  • Known or suspected allergy or intolerability to PEG
  • Prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial
  • Pregnancy and/or breast-feeding
  • History of malignant diseases (described in chapter 7.2)
  • Known or suspected non-compliance to study protocol
  • Participation in another investigational drug study in the last 30 days prior to baseline period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG-Formulation
PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)
Drug: PEG-Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Treatment period (6 months each).

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
The frequency of days with viral shedding which will be analysed by quantitative PCR.
Time Frame: Baseline and Treatment period (6 months each).
Baseline and Treatment period (6 months each).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Devirex AG

Investigators

  • Principal Investigator: Thomas Kuendig, MD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEV-PEG-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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