Safety and Efficacy of investigational drug for Cervical Intraepithelial Neoplasia(CIN)

JRCT ID: jRCT2051180201

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: CIN (CIN1 or CIN2)
• Date of first enrollment: 16/04/2019
• Target sample size: 22
• Study type: Interventional
• Intervention(s): investigational drug(FIT039CT)administration

Outcome(s)

• Primary Outcome: Adverse effect

Secondary Outcome

Blood drug concentration
Negative conversion of HPV

Key inclusion & exclusion criteria

• Age minimum: 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

<healthy female adults>
1)Healthy female adults who are 20 years or older at the time of signing informed consent
2)Subjects with no childbearing potential, defined as the subjects are postmenopausal (defined as continuous amenorrhea of at least 12 months without no pathological reason) or the subjects have been surgically sterilized (bilateral oophorectomy or tubal ligation).
3)Laboratory data obtained within 4 weeks prior to enrollment meet the following criteria:
Hemoglobin >= 10 g/dL ,WBC count >= 2,000 /uL ,Platelet count >= 100.000 /uL , AST <= 50 IU/L , ALT <= 50 IU/L , Total bilirubin <= 1.5 mg/dL , Creatinine <= 2.0 mg/dL, HbA1c(NGSP) < 7.0 %
4)Subjects willing to sign informed consent form to participate in the trial

<CIN patients>
1)Female adults who are 20 years or older at the time of signing informed consent
2)Patients who are histologically diagnosed as CIN 1 or 2
3)Patients who are positive for high risk HPVs in cervical HPV nucleic acid test
4)Laboratory data obtained within 4 weeks prior to enrollment meet the following criteria:
Hemoglobin >= 10 g/dL , WBC count >= 2,000 /uL , Platelet count >= 100,000 /uL , AST <= 50 IU/L , ALT <= 50 IU/L , Total bilirubin <= 1.5 mg/dL , Creatinine <= 2.0 mg/dL, HbA1c(NGSP) < 7.0 %
5)Patients willing to sign informed consent form to participate in the trial

Exclude criteria

<healthy female adults>
1)Subjects who have evidence of severe hepatic or renal disease, cardiovascular disorder defined as NYHA classification II or worse, have any cancer needs treatment
2)Subjects have severe inflammation of the uterus or vagina in the gynecological examination
3)Subjects were taking antiviral agents within 4 weeks prior to signing informed consent
4)Subjects participated in other studies within 4 weeks prior to signing informed consent
5)Subjects are judged by physicians that the potential subject's participation is inappropriate.

<CIN patients>
1)Patients who have evidence of severe hepatic or renal disease, cardiovascular disorder defined as NYHA classification II or worse, have any cancer needs treatment
2)Patients have severe inflammation of the uterus or vagina in the gynecological examination
3)Patients have history of surgical resection such as conization or laser ablation against CIN
4)Patients were taking antiviral agents within 4 weeks prior to signing informed consent
5)Patients participated in other studies within 4 weeks prior to signing informed consent
6)Patients who are pregnant or breastfeeding
7)Patients who will not comply with the following contraception and refrain from sexual intercourse
-Contraception within the period after signing informed consent until investigational drug administration
-Refrain from sexual intercourse during the following 14 days after investigational drug administration
-Contraception during the following 14 days after 14 days of investigational drug administration
8)Patients are judged by physicians that the potential patient's participation is inappropriate.

Related Information

• Primary Sponsor: Hamanishi Junzo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development