Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
NCT ID: NCT00051532
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
700 participants
INTERVENTIONAL
1999-09-30
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
OTHER
DOUBLE
Interventions
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Seocalcitol
Eligibility Criteria
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Inclusion Criteria
* Either sex
* Aged 18-75 years
* With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
* Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.
Exclusion Criteria
* Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
* A history of renal stone(s)
* A life expectancy of \< 3 months
* World Health Organization (WHO) performance status 3 or 4
* Okuda stage III.
* Patients with hypercalcemia, or other clinically important laboratory abnormalities
* Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.
* All patients must give their signed informed consent to join the study.
18 Years
75 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Principal Investigators
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Hanne Hvidberg, MSc Pharm, PhD
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)
Toronto, Alberta, Canada
E.g. Notre-Dame de Bon Secours, Service d“Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)
Metz, , France
E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)
Milan, , Italy
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
Barcelona, , Spain
E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Edinburgh, , United Kingdom
Countries
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Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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EBC 9801 INT
Identifier Type: -
Identifier Source: secondary_id
EBC 9801 INT
Identifier Type: -
Identifier Source: org_study_id
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