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

This study has been completed.
Sponsor:
Information provided by:
Mithra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01303328
First received: February 18, 2011
Last updated: February 15, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Uterine Cervical Neoplasia
Cervix Intraepithelial Neoplasia
Drug: C1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mithra Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy at week 12: change of histological and cytological parameters (success or not) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Efficacy at week 28: recurrence rate [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    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.

  • Tolerance and Safety (AE reporting, changes of gynecological and biological parameters) [ Time Frame: during 30 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Virological status (infection) [ Time Frame: during 30 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes in lesion (colposcopic changes) [ Time Frame: during 30 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group Drug: C1
Local application of the experimental gel or placebo gel.
Placebo Comparator: Placebo group Drug: C1
Local application of the experimental gel or placebo gel.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303328

Locations
Belgium
HIS Ixelles
Ixelles, Bruxelles, Belgium, 1050
CHU Charleroi Site André Vésale
Montigny-le-Tilleul, Charleroi, Belgium, 6110
CHU ND des Bruyères
Chenee, Liege, Belgium, 4032
Hôpital Saint Pierre
Bruxelles, Belgium, 1000
Hôpital Erasme
Bruxelles, Belgium, 1070
CHU Brugmann
Bruxelles, Belgium, 1020
CHU Charleroi Hôpital Civil
Charleroi, Belgium, 6000
CHU Tivoli
La Louvière, Belgium, 7100
CHR Citadelle
Liege, Belgium, 4000
Sponsors and Collaborators
Mithra Pharmaceuticals
Investigators
Principal Investigator: Philippe SIMON, MD, PhD, Professor Hôpital Erasme, service de gynécologie obstétrique
  More Information

No publications provided

Responsible Party: Maud Jost, Mithra Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01303328     History of Changes
Other Study ID Numbers: MI-CI-C02, 2010-023271-26
Study First Received: February 18, 2011
Last Updated: February 15, 2013
Health Authority: Belgium: AFMPS (FAMHP: Federal Agency for Medicines and Health Products)

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 18, 2014