Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

Cervix Intraepithelial Neoplasia Clinical Trial

— Colvir-PhaseII  

Official title:

A Randomized, Double-blind, Multi-centre, Placebo Controlled Phase II Clinical Study to Evaluate the Efficacy, Tolerance and Safety of an Aqueous Gel Containing an Antiviral, Directly Applied on the Cervix Exhibiting High Grade Intraepithelial Lesion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303328
• Other study ID #: MI-CI-C02
• Secondary ID: 2010-023271-26
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2011
• Last updated: February 15, 2013
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2012
• Source: Mithra Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: AFMPS (FAMHP: Federal Agency for Medicines and Health Products)
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

Description:

Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at:

• to evaluate the efficacy of a gel with antiviral directly applied on the cervix exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?

• to evaluate the safety and tolerance after local application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women aged between 18 and 50 years old

• Informed consent signed

• Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion

• No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)

Exclusion Criteria:

• Invasive or microinvasive cervical neoplasia

• Pregnancy or breast feeding

• Subtotal hysterectomy

• Current renal impairment

• Current immune disorder including serology HIV +

• Current use of drugs interfering with renal function

• Current use of oncologic treatment

• Current use of immune treatment

• Current use of anti-viral treatment

• Current vaginal application of drugs or cosmetics

• Prior treatment with the antiviral on the cervix

• Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

• Current or recent participation to another experimental study during the last 3 months before the screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervix Intraepithelial Neoplasia
• Neoplasms
• Uterine Cervical Neoplasia

Intervention

Drug:
• C1
Local application of the experimental gel or placebo gel.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Bruxelles
Belgium	Hôpital Erasme	Bruxelles
Belgium	Hôpital Saint Pierre	Bruxelles
Belgium	CHU Charleroi Hôpital Civil	Charleroi
Belgium	CHU ND des Bruyères	Chenee	Liege
Belgium	HIS Ixelles	Ixelles	Bruxelles
Belgium	CHU Tivoli	La Louvière
Belgium	CHR Citadelle	Liege
Belgium	CHU Charleroi Site André Vésale	Montigny-le-Tilleul	Charleroi

Sponsors (1)

Lead Sponsor	Collaborator
Mithra Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy at week 12: change of histological and cytological parameters (success or not)	Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.	12 weeks	No
Primary	Efficacy at week 28: recurrence rate	The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.	28 weeks	No
Primary	Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)	Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.	during 30 weeks	Yes
Secondary	Virological status (infection)	The viral load and genotypes of HPVhr will be determined before treatment, during follow-up and at the end of the study, by using a quantitative analysis.	during 30 weeks	No
Secondary	Changes in lesion (colposcopic changes)	Colposcopic description of lesion will be done before, during and after treatment of the lesion, during follow up and at the end of the study.	during 30 weeks	No