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

NCT ID: NCT01765114

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-Formulation

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

Group Type: EXPERIMENTAL

PEG-Formulation

Intervention Type: DRUG

Interventions

PEG-Formulation

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Devirex AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Kuendig, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

DEV-PEG-02

Identifier Type: -

Identifier Source: org_study_id