Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00606749 |
Date of registration:
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22/01/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Use of KC706 for the Treatment of Pemphigus Vulgaris
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Scientific title:
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A Phase 2 Open-Label Uncontrolled Pilot Study of KC706 in Patients With Stable, Active Pemphigus Vulgaris |
Date of first enrolment:
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November 2007 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00606749 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Victoria Werth, MD |
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Affiliation:
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University of Pennsylvania |
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Name:
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Bruce Strober, MD |
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Affiliation:
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NYU MEDICAL CENTER |
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Name:
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Michael Kolodney, MD |
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Affiliation:
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University of California, Los Angeles |
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Name:
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David Rubenstein, MD, PhD |
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Affiliation:
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University of North Carolina, Chapel Hill |
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Name:
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Francisco Kerdel, MD |
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Affiliation:
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Florida Academic Dermatology Centers |
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Name:
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Neil Korman, MD |
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Affiliation:
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University Hospital Case Medical Center |
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Name:
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Amit Pandya, MD |
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 18 years of age;
- Diagnosis of pemphigus vulgaris
- Patients must be taking and require either corticosteroid therapy or
immunosuppressive therapy or both;
- Immunosuppressive therapy, if any,should have been administered at a stable dose for
at least 60 days prior to the Baseline Visit and be well-tolerated, without the
expectation that there will be a need to increase that dose during the next 30 days;
- Corticosteroids, if any, should have been administered at a stable dose for at least
30 days prior to the Baseline Visit without expectation that there will be a need to
increase that dose during the next 30 days;
- Patients should have active PV skin, scalp or mucosal lesions that meet at least one
of the following criteria at the Baseline Visit:
- > 3 new lesions/week every week in the previous 3 weeks (skin, scalp, and/or
mucosal), with healing occurring at a rate to match the appearance of new
lesions; or
- At least 3 active, established lesions with a Pemphigus Lesion Score of at least
2; skin or scalp lesions must be = 5mm in diameter to qualify; there is no size
requirement for mucosal lesions; or,
- 1 large active established skin, scalp, or mucosal lesion > 10 mm;
- Accessibility to veins suitable for venipuncture;
- Patients must be cooperative, able to read, understand and give informed consent, and
able to adhere to the study visit schedule and protocol requirements; and,
- Patients must be willing to follow adequate contraceptive measures during the study
(both sexes).
Exclusion Criteria:
- Any history of opportunistic infections within 3 months prior to receiving study
drug;
- Infection with HIV;
- Past or present diagnosis of hepatitis confirmed by serology or elevated hepatic
enzymes;
- History of alcoholic liver disease or cirrhosis;
- Clinically significant concurrent medical disease or laboratory abnormalities
evidenced by one or more of the following:
- Hepatobiliary AST or ALT = 1.5 × upper limit of normal (ULN);alkaline
phosphatase = 1.5 × ULN; or, total bilirubin > 90% of the ULN;
- Renal serum creatinine > 1.5 mg/dL; or, significant proteinuria > 2+ on urinary
dip test;
- Hematologic hemoglobin < 11 mg/dL; leukocytes < 3.5 × 109/L; neutrophils < 1.5 ×
109/L; or, platelets < 100 × 109/L;
- Presence or history of malignancy;
- Uncontrolled diabetes (defined as diabetes requiring hospitalization or emergency
care in the 3 months prior to first dose of study drug);
- History or suspicion of Gilbert's syndrome;
- Significant blood loss (> 500 mL) within 28 days prior to receipt of study drug;
- Use of an investigational drug within 30 days of screening, or longer if that drug is
expected to have long-acting effects (e.g., modulation of B-cell activity);
- Use of Rituximab within the past 6 months;
- Use of intravenous IgG within the past 3 months,
- Current or recent history (within 12 months of screening) of drug or substance abuse,
including alcohol;
- Known or suspected pregnancy; nursing mothers;
- Clinically significant abnormality on the screening physical examination performed at
the Baseline Visit, laboratory testing, vital signs or electrocardiogram suggestive
of significant unstable medical condition other than the disease under study;
- Condition which, in the opinion of the Investigator, could interfere with
participation in the study or would put the patient at unacceptable risk;
- History of noncompliance with medical regimens.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pemphigus Vulgaris
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Intervention(s)
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Drug: KC706
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Primary Outcome(s)
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To evaluate the ability of KC706 to prevent the appearance of new lesions and heal existing lesions, while maintaining stable doses of corticosteroids and/or immunosuppressants in patients with pemphigus vulgaris.
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Evaluate the safety of KC706 in patients with PV and to assess plasma levels of KC706 with once daily dosing.
[Time Frame: 16 weeks]
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Secondary ID(s)
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KC706-C08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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