Herpes GenitalisPhase 2NCT00486200
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
A Phase 2 study testing ASP2151 and valacyclovir in people with Herpes Genitalis, run by Astellas Pharma Inc at 25 sites in United States.
Trial summary
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Genitalis
- What is being tested?
- ASP2151 and valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 695 participants
- Where
- 25 sitesUnited States
- Study dates
- 21 Jun 2007to 12 Aug 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a history of genital HSV documented by laboratory testing at screening
- Subject has experienced 4 or more episodes of genital herpes during the past 12 months
Who cannot join
- Subject is immunocompromised
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Annandale, Virginia, 22003
Study site
Arlington, Texas, 76011
Study site
Atlanta, Georgia, 30328
Study site
Baltimore, Maryland, 21201
Study site
Billings, Montana, 59101
Study site
Birmingham, Alabama, 35294
Study site
Boynton Beach, Florida, 33472
Study site
Denver, Colorado, 80262
Study site
Houston, Texas, 77030
Study site
Houston, Texas, 77058
Study site
Indianapolis, Indiana, 46202
Study site
Los Angeles, California, 90017
Study site
Madisonville, Kentucky, 42431
Study site
Miami, Florida, 33156
Study site
Omaha, Nebraska, 68134
Study site
Philadelphia, Pennsylvania, 19103
Study site
Phoenix, Arizona, 85015
Study site
Portland, Oregon, 97210
Study site
Sacramento, California, 95821
Study site
Salt Lake City, Utah, 84132
Study site
San Diego, California, 92108
Study site
Seattle, Washington, 98122
Study site
Tucson, Arizona, 85712
Study site
Westlake Village, California, 91361
About this study
Official title: A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
- Conditions
- Herpes Genitalis
- Being tested
- ASP2151, valacyclovir, Placebo
- Keywords
- ASP2151, Herpes Genitalis, Sexually Transmitted Disease, Herpes Simplex Virus Genital Infection, Treatment Outcome, Genital Herpes
- Medical subject headings
- Herpes Genitalis, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2151Drug
Oral administration.
valacyclovirDrug
Oral administration of active comparator.
PlaceboDrug
Oral administration of placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral administration of active comparator Receives: Drug: valacyclovir |
| 2 | Placebo comparator | Oral administration of placebo Receives: Drug: Placebo |
| 3 | Experimental | Dosing regimen 1 Receives: Drug: ASP2151 |
| 4 | Experimental | Dosing regimen 2 Receives: Drug: ASP2151 |
| 5 | Experimental | Dosing regimen 3 Receives: Drug: ASP2151 |
| 6 | Experimental | Dosing regimen 4 Receives: Drug: ASP2151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
Measured: 17 days
Secondary outcomes (1)
Pharmacokinetics in study patients
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study start21 Jun 2007
- Primary completion12 Aug 2008
- Study completion12 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes GenitalisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486200
- Sponsor's protocol ID
- 15L-CL-101
- Status last verified
- Dec 2017
- First submitted
- 12 Jun 2007
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R. ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. J Infect Dis. 2012 Apr 1;205(7):1100-10. doi: 10.1093/infdis/jis019. Epub 2012 Feb 20.
PubMed 22351940
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
- ClinicalTrials.gov ID
- NCT00486200
- Acronym / sponsor ID
- 15L-CL-101
- Conditions
- Herpes Genitalis
- Keywords
- ASP2151, Herpes Genitalis, Sexually Transmitted Disease, Herpes Simplex Virus Genital Infection, Treatment Outcome, Genital Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2007 (actual)
- Primary completion
- 12 Aug 2008 (actual)
- Study completion
- 12 Aug 2008 (actual)
- First posted
- 14 Jun 2007 (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.
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: valacyclovirOral administration of active comparator |
| 2 | Placebo comparator | Drug: PlaceboOral administration of placebo |
| 3 | Experimental | Drug: ASP2151Dosing regimen 1 |
| 4 | Experimental | Drug: ASP2151Dosing regimen 2 |
| 5 | Experimental | Drug: ASP2151Dosing regimen 3 |
| 6 | Experimental | Drug: ASP2151Dosing regimen 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a history of genital HSV documented by laboratory testing at screening
- Subject has experienced 4 or more episodes of genital herpes during the past 12 months
Key exclusion criteria (1 listed)
- Subject is immunocompromised
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 |
|---|---|---|
| ASP2151Oral administration. | Drug | 3, 4, 5, 6 |
| valacyclovirOral administration of active comparator. | Drug | 1 |
| PlaceboOral administration of placebo. | Drug | 2 |
Primary outcome
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
Time frame: 17 days
1 secondary outcome
Pharmacokinetics in study patients
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Background: PubMed 22351940Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R. ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. J Infect Dis. 2012 Apr 1;205(7):1100-10. doi: 10.1093/infdis/jis019. Epub 2012 Feb 20.
- Individual participant dataSharing planned: Undecided
Related trials for Herpes Genitalis
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP2151 and valacyclovir in people with Herpes Genitalis, run by Astellas Pharma Inc at 25 sites in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00486200, which also lists 1 linked publication.
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 7 Dec 2017.