Uterine Cervical NeoplasiaPhase 2Colvir-PhaseIINCT01303328
Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)
A Phase 2 study testing C1 in people with Uterine Cervical Neoplasia and Cervix Intraepithelial Neoplasia, run by Mithra Pharmaceuticals at 9 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasia, Cervix Intraepithelial Neoplasia
- What is being tested?
- C1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 9 sitesBelgium
- Study dates
- Mar 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Belgium9 sites
Hôpital Saint Pierre
Brussels, Brussels Capital, 1000
CHU Brugmann
Brussels, Brussels Capital, 1020
Hôpital Erasme
Brussels, Brussels Capital, 1070
CHU Charleroi Hôpital Civil
Charleroi, Charleroi, 6000
CHU ND des Bruyères
Chênée, Liege, 4032
HIS Ixelles
Ixelles-Elsene, Brussels Capital, 1050
CHU Tivoli
La Louvière, La Louvière, 7100
CHR Citadelle
Liège, Liege, 4000
CHU Charleroi Site André Vésale
Montigny-le-Tilleul, Charleroi, 6110
About this study
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.
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.
Read the 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.
- Being tested
- C1
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1Drug
Local application of the experimental gel or placebo gel.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: C1 |
| Placebo group | Placebo comparator | Not described Receives: Drug: C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 28 weeks
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.
Measured: during 30 weeks
Secondary outcomes (2)
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.
Measured: during 30 weeks
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.
Measured: during 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mithra Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philippe SIMON, MD, PhD, Professor, Principal investigator, Hôpital Erasme, service de gynécologie obstétrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303328
- Sponsor's protocol ID
- MI-CI-C02
- Other IDs
- 2010-023271-26
- Acronym
- Colvir-PhaseII
- Status last verified
- Aug 2012
- First submitted
- 18 Feb 2011
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01303328
- Acronym / sponsor ID
- Colvir-PhaseII / MI-CI-C02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mithra PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: C1 |
| Placebo group | Placebo comparator | Drug: C1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- Invasive or microinvasive cervical neoplasia
- Pregnancy or breast feeding
- Subtotal hysterectomy
- Current renal impairment
- Current immune disorder including serology HIV +
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C1Local application of the experimental gel or placebo gel. | Drug | Placebo group, Treatment group |
Primary outcome
Efficacy at week 12: change of histological and cytological parameters (success or not)
Time frame: 12 weeks
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
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
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.
2 secondary outcomes
Virological status (infection)
Time frame: during 30 weeks
Changes in lesion (colposcopic changes)
Time frame: during 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe SIMON, MD, PhD, Professor principal investigator
Hôpital Erasme, service de gynécologie obstétrique
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C1 in people with Uterine Cervical Neoplasia and Cervix Intraepithelial Neoplasia, run by Mithra Pharmaceuticals at 9 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy at week 12: change of histological and cytological parameters (success or not) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.