Cervical Persistent High Risk HPV InfectionPhase 2NCT02304770
Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia
A Phase 2 study testing Aminolaevulinic acid photodynamic therapy in people with Cervical Persistent High Risk HPV Infection and Cervical Intraepithelial Neoplasia, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Cervical Persistent High Risk HPV Infection, Cervical Intraepithelial Neoplasia
- What is being tested?
- Aminolaevulinic acid photodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2015to Jan 2017
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women, 25-50 years of age
- Meet one of the 3 following conditions:
- high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function
- Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
- In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
- Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
- Written informed consent signed
Who cannot join
- Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or positive endocervical curettage on colposcopy
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds
- Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases
Show all 10Show fewer
- Pregnancy or nursing
- Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study
- Participation in any clinical studies within the last 30 days
- Subjects that the investigators judged to be not suitable to participate the study besides above
Trial locations and contacts
4 sites in 1 country.
China4 sites
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
The First Affliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210036
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Pilot Study of Aminolaevulinic Acid (ALA) Photodynamic Therapy (PDT) in Patients With Cervical Persistent High Risk HPV Infection or Cervical Intraepithelial Neoplasia
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
- Being tested
- Aminolaevulinic acid photodynamic therapy
- 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.
Aminolaevulinic acid photodynamic therapyDrug
Aminolaevulinic acid mediated photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| cervical persistent high risk HPV infection | Experimental | Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection Receives: Drug: Aminolaevulinic acid photodynamic therapy |
| CIN 1 with high risk HPV infection | Experimental | Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection Receives: Drug: Aminolaevulinic acid photodynamic therapy |
| CIN 2/3 | Experimental | Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3 Receives: Drug: Aminolaevulinic acid photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Based on histology
Measured: 3 months after treatments
clearance of high risk HPV
proportion of patients with high risk HPV clearance
Measured: 3 months after treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Persistent High Risk HPV InfectionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beihua Kong, MD, Principal investigator, Qilu Hospital of Shandong UniversityYouzhong Zhang, MD, Principal investigator, Qilu Hospital of Shandong UniversityJining Tao, Master, Study director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304770
- Sponsor's protocol ID
- FDZJALA-201409
- Status last verified
- Jun 2019
- First submitted
- 23 Nov 2014
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Aminolaevulinic Acid (ALA) Photodynamic Therapy (PDT) in Patients With Cervical Persistent High Risk HPV Infection or Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT02304770
- Acronym / sponsor ID
- FDZJALA-201409
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Dec 2014 (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 study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cervical persistent high risk HPV infection | Experimental | Drug: Aminolaevulinic acid photodynamic therapyAminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection |
| CIN 1 with high risk HPV infection | Experimental | Drug: Aminolaevulinic acid photodynamic therapyAminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection |
| CIN 2/3 | Experimental | Drug: Aminolaevulinic acid photodynamic therapyAminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Premenopausal women, 25-50 years of age
- Meet one of the 3 following conditions:
- high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function
- Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
- In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
Key exclusion criteria (10 listed)
- Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or positive endocervical curettage on colposcopy
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds
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 |
|---|---|---|
| Aminolaevulinic acid photodynamic therapyAminolaevulinic acid mediated photodynamic therapy | Drug | CIN 1 with high risk HPV infection, CIN 2/3, cervical persistent high risk HPV infection |
Primary outcome
Response Rate
Time frame: 3 months after treatments
Based on histology
clearance of high risk HPV
Time frame: 3 months after treatments
proportion of patients with high risk HPV clearance
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 12 Jun 2019.
Related trials for Cervical Persistent High Risk HPV Infection
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Not yet recruitingPhase 2
Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.
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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.
Beihua Kong, MD principal investigator
Qilu Hospital of Shandong University
Youzhong Zhang, MD principal investigator
Qilu Hospital of Shandong University
Jining Tao, Master study director
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
4 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 Aminolaevulinic acid photodynamic therapy in people with Cervical Persistent High Risk HPV Infection and Cervical Intraepithelial Neoplasia, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites in China.
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 7 inclusion and 10 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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. 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?
Response Rate (time frame: 3 months after treatments). The study lists 2 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 12 Jun 2019.