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This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAMB 200 mg | Experimental | 200 mg CAMB (MAT2203) Oral Amphotericin B |
|
| CAMB 400 mg | Experimental | 400 mg CAMB (MAT2203) Oral Amphotericin B |
|
| Fluconazole 150 mg | Active Comparator | Fluconazole Diflucan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Encochleated Amphotericin B (CAMB) | Drug | lipid-crystal nano-particle formulation amphotericin B |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome Assessed at Test of Cure Visit | Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure) | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mycological Outcome Assessed at Test of Cure | Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated) | 12 days |
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Key Inclusion Criteria:
Informed consent
Clinical diagnosis of moderate to severe VVC
Negative pregnancy test
Vaginal pH less than 4.5
Key Exclusion Criteria:
Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs
Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months
Has another cause of vulvovaginitis
Has other urogenital infection(s) that would potentially alter their response to disease
Has another vaginal or vulvar condition that would confound the interpretation of clinical response
Has significant laboratory abnormality at screening
Has any known azole-resistant Candida infection;
Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Kling | Matinas BioPharma Nanotechnologies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35205 | United States | ||
| Precision Trials, LLC |
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Enrolled patients were excluded from the study before assignment to groups due to abnormal laboratory test results, negative potassium hydroxide test (KOH) for vaginal yeast or vaginal pH greater than 4.5 during the screening process.
Recruitment period November 2016 to May 2017 at 22 medical clinics in USA
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| ID | Title | Description |
|---|---|---|
| FG000 | CAMB 200 mg | 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B |
| FG001 | CAMB 400 mg | 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2017 |
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| Fluconazole | Drug |
|
| Overall Response | Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure). | 12 Days |
| Change in Composite Clinical Cure Score | The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome. The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome. | Between randomization visit (Baseline) and Day 12 visit (Test of Cure) |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Neostart Corporation dba AGA Clinical Trials | Hialeah | Florida | 33012 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Advanced Research Institute Inc | New Port Richey | Florida | 34653 | United States |
| Healthcare Clinical Data, Inc. | North Miami | Florida | 33161 | United States |
| Clinical Research of West Florida - Tampa | Tampa | Florida | 33603 | United States |
| Visions Clinical Research | Wellington | Florida | 33414 | United States |
| Mt. Vernon Clinical Research - Wake Research | Atlanta | Georgia | 30328 | United States |
| Brighton Clinical Research Associates | Norcross | Georgia | 30092 | United States |
| Medpharmics | Metairie | Louisiana | 70006 | United States |
| New England Center for Clinical Research, Inc. | Fall River | Massachusetts | 02720 | United States |
| Lawrence OB/GYN | Lawrenceville | New Jersey | 08648 | United States |
| ProHEALTH Care Associates, LLC - Suffolk OB-GYN | Port Jefferson | New York | 11777 | United States |
| PMG Research of Salisbury, LLC. | Salisbury | North Carolina | 28144 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Complete Health Care for Women | Columbus | Ohio | 43231 | United States |
| Study Center | Columbus | Ohio | 43231 | United States |
| Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Tidewater Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| FG002 | Fluconazole 150 mg | Fluconazole Diflucan Fluconazole |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CAMB 200 mg | 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B |
| BG001 | CAMB 400 mg | 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B |
| BG002 | Fluconazole 150 mg | Fluconazole Diflucan Fluconazole |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| 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 | Clinical Outcome Assessed at Test of Cure Visit | Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure) | All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline | Posted | Count of Participants | Participants | 12 days |
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| Secondary | Mycological Outcome Assessed at Test of Cure | Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated) | All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline | Posted | Count of Participants | Participants | 12 days |
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| Secondary | Overall Response | Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure). | All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline | Posted | Count of Participants | Participants | 12 Days |
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| Secondary | Change in Composite Clinical Cure Score | The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome. The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome. | All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline | Posted | Mean | Standard Deviation | percent change | Between randomization visit (Baseline) and Day 12 visit (Test of Cure) |
|
Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.
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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 | CAMB 200 mg | 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B | 0 | 46 | 0 | 46 | 10 | 46 |
| EG001 | CAMB 400 mg | 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B | 0 | 45 | 0 | 45 | 12 | 45 |
| EG002 | Fluconazole 150 mg | Fluconazole Diflucan Fluconazole | 0 | 46 | 0 | 46 | 4 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bacterial Vaginosis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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This is a proof of concept study not designed or powered to support an indication for the treatment of VVC but to establish safety, tolerability and efficacy in a non-life threatening fungal infection.
Data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential and must consult with the Sponsor before any study data are submitted for publication. Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Development | Matinas Biopharma | 9082953235 | jjohnson@matinasbiopharma.com |
| Sep 7, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014848 | Vulvovaginitis |
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Clinical Indeterminate |
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Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics. |
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| Participants |
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| OG002 | Fluconazole 150 mg | Fluconazole Diflucan Fluconazole |
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