A Study to Investigate the Efficacy, Safety and Tolerabil... | NCT01765114

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

NCT01765114

Sponsor

Devirex AG

Status

Terminated

Last Update Posted

Aug 5, 2014Estimated

Enrollment

8Actual

Phase

Phase 2

Conditions

Genital Herpes

Interventions

PEG-Formulation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient patient recruitment

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Dec 14, 2012

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2014

Last Update Posted Date

Aug 5, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEG-Formulation	Experimental	PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)	Drug: PEG-Formulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEG-Formulation	Drug		PEG-Formulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kuendig, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006558	Herpes Genitalis

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided