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| Sponsored by: |
LEO Pharma |
|---|---|
| Information provided by: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT00051545 |
Purpose
To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e.
percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Neoplasms |
Drug: Seocalcitol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma |
| Estimated Enrollment: | 608 |
| Study Start Date: | November 1999 |
| Estimated Study Completion Date: | June 2004 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting) | |
| Toronto, Ontario, Canada, M5G2C4 | |
| France | |
| E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France) | |
| Metz, France, F-57038 Metz Cedex | |
| Italy | |
| E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy) | |
| Milano, Italy, I-20 122 | |
| Spain | |
| E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain) | |
| Barcelona, Spain, E-08036 | |
| United Kingdom | |
| E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK) | |
| Edinburgh, United Kingdom, EH3 9YW | |
| Study Director: | Hanne Hvidberg, MScPharm PhD | LEO Pharma |
More Information
| Study ID Numbers: | EBC 9802 INT |
| Study First Received: | January 13, 2003 |
| Last Updated: | February 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00051545 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
liver cancer hepatocellular carcinoma |
|
Liver Diseases Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Adjuvants, Immunologic Seocalcitol Immunosuppressive Agents |
Carcinoma Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
|
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Seocalcitol Immunosuppressive Agents |
Pharmacologic Actions Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Neoplasms, Glandular and Epithelial |