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Sponsored by: |
NatImmune A/S |
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Information provided by: | NatImmune A/S |
ClinicalTrials.gov Identifier: | NCT00644579 |
As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC in two dose groups to immune suppressed, kidney transplanted patients.
Condition | Intervention | Phase |
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Cutaneous Warts |
Drug: bLAC Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | bLAC - A Phase II Double-Blind, Placebo Controlled, Clinical Proof of Concept Trial of the Efficacy of 8 Weeks Treatment of Cutaneous Warts With bLAC in Immune Suppressed, Kidney Transplanted Patients |
Estimated Enrollment: | 120 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
bLAC high dose
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Drug: bLAC
bLAC high and low dose and placebo
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2: Active Comparator
bLAC low dose
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Drug: bLAC
bLAC high and low dose and placebo
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3: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Claus Zachariae, MD, Chief Physician | +4539773203 | clza@geh.regionh.dk |
Denmark | |
Gentoftte Amtssygehus | Recruiting |
Hellerup, Denmark, DK-2900 | |
Principal Investigator: Claus Zachariae, MD | |
Bispebjerg University Hospital | Recruiting |
Copenhagen NV, Denmark, DK-2400 | |
Principal Investigator: Merete Hædersdal, MD | |
Odense University Hospital | Recruiting |
odense, Denmark, DK-5000 | |
Principal Investigator: Henrik Lorentzen, MD | |
Marselisborg University Hospital | Recruiting |
Aarhus C, Denmark, DK-8000 | |
Principal Investigator: Mette S Deleuran, MD | |
Dermatology Clinic, Vesterbro | Recruiting |
Aalborg, Denmark, DK-9000 | |
Principal Investigator: Henrik Sølvsten, MD |
Principal Investigator: | Claus Zachariae, MD | Gentofte Amtssygehus |
Responsible Party: | NatImmune ( NatImmune A/S ) |
Study ID Numbers: | CL-1205, EudraCT number: 2007-006738-33 |
Study First Received: | March 25, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00644579 |
Health Authority: | Denmark: Danish Medicines Agency |
wart cutaneous transplant Cutaneous warts in immune suppressed, kidney transplant patients |
Virus Diseases Skin Diseases, Infectious Warts |
Skin Diseases DNA Virus Infections Papillomavirus Infections |
Skin Diseases, Viral Neoplasms Tumor Virus Infections |