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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02139267
Other study ID # GX-188E_CIN3_P2
Secondary ID
Status Completed
Phase Phase 2
First received May 13, 2014
Last updated July 11, 2017
Start date July 2014
Est. completion date March 2016

Study information

Verified date July 2017
Source Genexine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).


Description:

Subjects who are eligible for this study are allocated to one of the two treatment groups of GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on alternating deltoid muscles which will be performed totally three times during the study period.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

1. Voluntarily signed informed consent form after receiving education about this study and the investigational product.

2. Female aged between 19 and 50 years

3. Positive test results for HPV Type 16 and/or Type 18

4. Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3

5. Entire cervical area including entire squamocolumnar junction is visualized through colposcopy

6. Eligible based on screening test results.

7. Promised not to get pregnant throughout the study

Exclusion Criteria:

1. Suspected Adenocarcinoma in situ

2. Malignant cancer more than Stage I

3. Pregnancy or breastfeeding

4. Participation in clinical trials within 30 days of the screening visit

5. Administration of immunosuppressant or immunomodulator within 6 months prior to the enrolment

6. Administered with systemic steroid(as a standard with Prednisolone, more than 20mg/day for every 14 days or more) within 3 months of Day 1(including ointment, eye drops, inhalated or nasal, intra-ligamental or intra-articular injection, but not applicable if injected every other day

7. Administered any blood products within 3 months prior to the screening visit

8. Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A, Hepatitis B, Influenza, Td etc.)

9. Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg) or HIV

10. Severe hepatopathy which is Class C according to Child-Pough's classification

11. Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min

12. CPK test results more than 2.5 times the upper limit of normal

13. Predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit

14. History of severe adverse drug events or severe allergic diseases

15. History of epilepsy or convulsion within 2 years prior to the screening visit

16. At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.

17. The thickness of skin fold covering deltoid muscles, intended injection sites, > 40mm

18. Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)

19. Sinus bradycardia whose resting heart rate < 50 beats/min

20. Pre-excitation syndrome such as Wolff-Parkinson-White syndrome

21. Abnormal electrocardiography(ECG) including arrhythmia

22. Artificial implants or metallic implants

23. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Study Design


Intervention

Biological:
GX-188E
DNA vaccine administered via IM route using TDS-IM electroporation device

Locations

Country Name City State
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Cheil General Hospital & Women's Healthcare Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of The Catholic University of Korea Seoul St.Mary's Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less 20 weeks
Secondary The Rate of Participants Whose Result Inverted Negative in HPV DNA test 20 weeks
Secondary The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol 20 weeks
Secondary Cytological Changes of the Cervical Lesions 20 weeks
Secondary The Rate of Adverse Events and the Related Features after Administration of Investigational Product 20 weeks
Secondary The Rate of Solicited Adverse Events and the Related Features 20 weeks
Secondary Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product 20 weeks
Secondary Mean Value of Visual Analogue Scale on Pain Intensity 20 weeks
Secondary Flt-3L Serum Concentration 20 weeks
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