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:
Mithra Pharmaceuticals
Information provided by:
Mithra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01303328
First received: February 18, 2011
Last updated: February 15, 2013
Last verified: August 2012
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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
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 Cervical Intraepithelial Neoplasia Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013