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Sponsored by: |
Microbio Co Ltd |
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Information provided by: | Microbio Co Ltd |
ClinicalTrials.gov Identifier: | NCT00707681 |
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients using European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.
Condition | Intervention | Phase |
---|---|---|
Hepatocellular Carcinoma |
Drug: MS-20 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Controlled Study to Evaluate the Quality of Life, Survival and Therapeutic Benefits of MS-20 in Patient With Advanced Hepatocellular Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Active Comparator
MS-20
|
Drug: MS-20
4 ml/vial
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
4ml/vial
|
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects may be included in the study only if they meet all of the following criteria:
Histologically documented, unresectable advanced HCC. For patients with difficulty in obtaining histological diagnosis, a "clinical diagnosis" of HCC is acceptable if all the following criteria are met:
Patient fulfilling any of the follow conditions:
Exclusion Criteria
Subjects will be excluded from the study for any of the following reasons:
Female subjects of childbearing potential who:
Contact: David Yeh, MS | 886226558558 ext 306 | davidyeh@microbio.com.tw |
Contact: Peter Pan, MS | 886226558558 ext 311 | peterpan@microbio.com.tw |
Taiwan | |
China Medical University Hospital | Recruiting |
TaiChung, Taiwan, 40447 | |
Contact: Cheng-Yuan Peng, MD 886422052121 ext 2264 cypeng@www.cmuh.org.tw | |
Principal Investigator: Cheng-Yuan Peng, MD |
Principal Investigator: | Cheng-Yuan Peng, MD | China Medical University Hospital |
Responsible Party: | MicroBio Co., Ltd. ( Mr. David Yeh, Director ) |
Study ID Numbers: | MCRA06001A |
Study First Received: | June 30, 2008 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00707681 |
Health Authority: | United States: Food and Drug Administration |
microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Quality of Life Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |