Trials / Unknown
UnknownNCT03206138
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.
A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Seoul St. Mary's Hospital · Academic / Other
- Sex
- Female
- Age
- 19 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GX-188E, GX-I7 | Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times. |
| BIOLOGICAL | GX-188E, Imiquimod | 1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times. |
Timeline
- Start date
- 2017-05-30
- Primary completion
- 2018-10-01
- Completion
- 2018-10-01
- First posted
- 2017-07-02
- Last updated
- 2017-07-02
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03206138. Inclusion in this directory is not an endorsement.