Back to resultsA Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes
Primary Purpose
Genital Herpes
Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
PEG-Formulation
Sponsored by
About this trial
This is an interventional treatment trial for Genital Herpes
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-Formulation
Arm Description
PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)
Outcomes
Primary Outcome Measures
Change of number of genital herpes recurrences during the treatment period as compared to the baseline period.
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.
Secondary Outcome Measures
The safety of the PEG-formulation via reporting of AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01765114
Brief Title
A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes
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 Suffering From Genital Herpes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
insufficient patient recruitment
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Devirex AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-Formulation
Arm Type
Experimental
Arm Description
PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)
Intervention Type
Drug
Intervention Name(s)
PEG-Formulation
Primary Outcome Measure Information:
Title
Change of number of genital herpes recurrences during the treatment period as compared to the baseline period.
Description
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.
Time Frame
Baseline and Treatment period (6 months each).
Secondary Outcome Measure Information:
Title
The safety of the PEG-formulation via reporting of AEs.
Time Frame
Baseline and Treatment period (6 months each).
Other Pre-specified Outcome Measures:
Title
The frequency of days with viral shedding which will be analysed by quantitative PCR.
Time Frame
Baseline and Treatment period (6 months each).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kuendig, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes
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