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Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study
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The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.
In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2) |
|
| 2 | Placebo Comparator | Placebo suppository (single administration), laser illumination (50J/cm2) |
|
| 3 | No Intervention | ||
| 4 | Active Comparator | HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2) |
|
| 5 | Placebo Comparator | Placebo ointment (single administration), no illumination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexaminolevulinate (HAL) | Drug | Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication of HPV | High risk HPV | 6 months |
| Incidence of Patients With Adverse Events | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hillemanns, MD, PhD | Medizinische Hochschule Hannover, Hannover, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gyneacology, Lille University Hospital | Lille | France | ||||
| Department of Obstetrics and Gynecology |
Recruitment to part 1, including arms 1-3, completed before initiation of part 2 (arms 4-5). Arms 4 and 5 was a protocol amendment.
All subjects recruited from medical clinics/hospitals. Start of recruitment arms 1-3: Jan 2009 End of recruitment arms 1-3: Feb 2010 Start of recruitment arms 4-5: Nov 2010 End of recruitment arms 4-5: Jul 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: HAL Suppository, Laser Illumination | |
| FG001 | Arm 2: Placebo Suppository, Laser Illumination | |
| FG002 | Arm 3: No Intervention | |
| FG003 | Arm 4: HAL Ointment, LED Diode Illumination | |
| FG004 | Arm 5: Placebo Ointment, no Illumination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: HAL Suppository, Laser Illumination | |
| BG001 | Arm 2: Placebo Suppository, Laser Illumination | |
| BG002 | Arm 3: No Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response Rate | Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV. | Per protocol population. Patients with major protocol violations excluded. | Posted | Number | percentage of no. of patients analyzed | 6 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: HAL Suppository, Laser Illumination |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw fracture | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine pain | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
Slow recruitment lead to early terminaiton of the second part of the trial, including arms 4 and 5, after enrolment of 13 patients. No formal statistical analysis conducted on this part of the data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bjørn Klem, Project Director | Photocure | +47 22 06 22 10 | bk@photocure.no |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
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| Placebo | Drug | Placebo suppository, for 3-7 hours application |
|
| Hexaminolevulinate (HAL) | Drug | Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application |
|
| Placebo | Drug | Placebo ointment for 5 hours application |
|
| Hanover |
| Germany |
| Fritzøe klinikk | Larvik | Norway |
| Department of Obstetrics and Gynaecology, Ullevål University Hospital | Oslo | Norway |
| Medicus | Trondheim | Norway |
| BG003 | Arm 4: HAL Ointment, LED Diode Illumination |
| BG004 | Arm 5: Placebo Ointment, no Illumination |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Arm 4: HAL Ointment, LED Diode Illumination |
| OG004 | Arm 5: Placebo Ointment, no Illumination |
|
|
| Secondary | Eradication of HPV | High risk HPV | Patients who were positive for high risk HPV at baseline | Posted | Number | percentage of no. of patients analyzed | 6 months |
|
|
|
| Secondary | Incidence of Patients With Adverse Events | All patients treated | Posted | Number | percentage of no of patients analyzed | 3 months |
|
|
|
| 3 |
| 47 |
| 16 |
| 47 |
| EG001 | Arm 2: Placebo Suppository, Laser Illumination | 0 | 12 | 3 | 12 |
| EG002 | Arm 3: No Intervention | 1 | 11 | 1 | 11 |
| EG003 | Arm 4: HAL Ointment, LED Diode Illumination | 0 | 10 | 6 | 10 |
| EG004 | Arm 5: Placebo Ointment, no Illumination | 0 | 3 | 2 | 3 |
| Schizophrenia | Psychiatric disorders |
|
| Concomitant disease aggravated | General disorders |
|
| Depression | Psychiatric disorders |
|
| Pain | General disorders | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | Systematic Assessment |
|
| Discomfort | General disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
The PI may publish the results from his/her site, provided that the publication does not disclose confidential information or interfere with sponsor's efforts to obtain patent protection for inventions. The sponsor must receive material for review not less than sixty (60) days prior to their proposed submission.
In this multi center study, collective publications are anticipated. The PI must not independently publish the results of the Study before the first collective publication.
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |