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

NCT01765114 | Terminated Phase 2

• 1 other identifier: DEV-PEG-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Treatment period (6 months each).

Secondary Outcomes (1)

• The safety of the PEG-formulation via reporting of AEs.

  Baseline and Treatment period (6 months each).

Other Outcomes (1)

• The frequency of days with viral shedding which will be analysed by quantitative PCR.

  Baseline and Treatment period (6 months each).

Study Arms (1)

PEG-Formulation

EXPERIMENTAL

PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)

Drug: PEG-Formulation

Interventions

PEG-Formulation DRUG

PEG-Formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Devirex AG: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Study Officials

• Thomas Kuendig, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: January 10, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

CH (1)