Genital HerpesPhase 2NCT01765114
A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes
A Phase 2 study testing PEG-Formulation in people with Genital Herpes, run by Devirex AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Genital Herpes
- What is being tested?
- PEG-Formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
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
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
- Being tested
- PEG-Formulation
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-FormulationDrug
| Study group | Role | What they receive |
|---|---|---|
| PEG-Formulation | Experimental | PEG-Formulation, applied twice daily during the treatment period (duration: 6 months) Receives: Drug: PEG-Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Treatment period (6 months each).
Secondary outcomes (1)
The safety of the PEG-formulation via reporting of AEs.
Measured: Baseline and Treatment period (6 months each).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: insufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Devirex AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Kuendig, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765114
- Sponsor's protocol ID
- DEV-PEG-02
- Status last verified
- Aug 2014
- First submitted
- 14 Dec 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01765114
- Acronym / sponsor ID
- DEV-PEG-02
- Conditions
- Genital Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Devirex AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-Formulation | Experimental | Drug: PEG-FormulationPEG-Formulation, applied twice daily during the treatment period (duration: 6 months) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-Formulation | Drug | PEG-Formulation |
Primary outcome
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.
1 secondary outcome
The safety of the PEG-formulation via reporting of AEs.
Time frame: Baseline and Treatment period (6 months each).
Results and safety
The study was stopped early (reason given: insufficient patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kuendig, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-Formulation in people with Genital Herpes, run by Devirex AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.