Clinical Trials List
2011-01-01 - 2017-12-31
Phase III
Terminated9
A prospective, randomized, double-blind, placebo-controlled, parallel-group, international multicenter phase III trail of PI-88 in the adjuvant treatment of subjects with hepatitis virus related hepatocellular
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Trial Applicant
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Sponsor
Medigen Biotechnology Corporation
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chun-Jen Liu Division of General Internal Medicine
- 李伯皇 Division of General Surgery
- REY-HENG HU Division of General Surgery
- Yao-Ming Wu Division of General Surgery
- PEI-JER CHEN Division of General Internal Medicine
- Ming-Chih Ho Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 周宏學 Division of General Surgery
- 洪建福 Division of Radiology
- 李正方 Division of General Surgery
- Kun-Ming Chan Division of General Surgery
- Ming-Chin Yu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 夏振源 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 葉宏仁 Digestive System Department
- TENG-YU LEE Digestive System Department
- Sheng-Shun Yang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 楊宏仁 Division of General Surgery
- Cheng-Yuan Peng Digestive System Department
- Mei-Due Yang Division of General Surgery
- Po-Heng Chuang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yan-Shen Shan Division of General Surgery
- 周宗慶 Division of General Surgery
- Yih-Jyh Lin Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
2.Secondary Outcome Measures: Time to Recurrence (TTR)、Overall Survival (OS) 、Tumor Recurrence Rate (TR Rate)
Inclution Criteria
2. Age ≥ 18 years.
3. Written, signed and dated informed consent to participate in study
4. ECOG performance status 0 to 1
5. Child Pugh score ≤ 8
6. Platelet count ≥ 80 x 109 cells/liter
7. PT-INR ≤ 1.3
8. aPTT ≤ upper limit of normal
Exclusion Criteria
2. History of immune-mediated thrombocytopenia other platelet abnormalities or other hereditary or acquired coagulopathies, or laboratory evidence of anti-heparin antibodies, or any previous history of having tested positive for anti-heparin antibodies.
3. Any evidence of tumor metastasis or co-existing malignant disease
4. Any prior recurrence of HCC or any liver resection prior to the most recent procedure
5. Clinically significant non-malignant disease including, but not limited to, surgery within 6 weeks of randomization (apart from liver resection and re-operation for complications of liver resection), active clinically significant infection within 6 weeks prior to randomization, myocardial infarction within 6 months prior to randomization, cerebrovascular event within 12 months prior to randomization or clinically-significant gastrointestinal bleeding within 12 months prior to randomization. Subjects who have experienced post-operative complications of liver resection may be enrolled providing that such complications are fully resolved at the time of screening.
6. Subjects with uncontrolled infection or serious infection within the past 4 weeks.
7. History of prior HCC therapy including chemotherapy, radiotherapy, molecular targeting agents, vaccines, transarterial embolization (TAE), transarterial chemoembolization (TACE), liver transplantation or surgical resection prior to the most recent hepatectomy, at any time prior to randomization. This includes pre-, peri- and post-operative treatments. Pre-operative portal vein embolization is permitted. Subjects should not be enrolled if, at the time of randomization, it is planned that they will subsequently undergo liver transplantation regardless of tumor recurrence.
8. Concomitant use of aspirin (> 150 mg/day), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomization, or other anti-platelet drugs (e.g. abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). Low dose aspirin (≤ 150 mg/day) and low-dose prophylactic vitamin K antagonists (e.g. warfarin ≤ 1 mg/day) are permitted as concomitant medications.
9. History of allergic, anaphylactic or other significant adverse reaction to radiographic contrast media (iodinated or non-iodinated), which cannot be managed by pre-treatment with agents such as steroids or anti-histamines, and which, in the opinion of the investigator, renders the subject unsuitable for routine CT scanning. Subjects who are contra-indicated for CT scanning for other reasons (e.g. ferromagnetic implants, profound claustrophobia), should not be enrolled.
10. Subjects with history of inflammatory bowel disease, any other abnormal bleeding tendency, or subjects at risk of bleeding due to open wounds or planned surgery.
11. Women who are pregnant or breast-feeding or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
12. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the subject to comply with the protocol.
13. Subjects who received other investigational or anti-neoplastic medication within the past 4 weeks.
14. Current participation in any other clinical study or research project which involves administration of a pharmaceutical product or experimental treatment, or which involves protocol-specified laboratory tests, imaging studies or other investigations.
The Estimated Number of Participants
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Taiwan
240 participants
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Global
500 participants
