PI-88 in Hepatocellular Carcinoma After Hepatectomy
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ClinicalTrials.gov Identifier: NCT00247728 |
Recruitment Status :
Completed
First Posted : November 2, 2005
Results First Posted : November 12, 2020
Last Update Posted : November 12, 2020
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Sponsor:
Medigen Biotechnology Corporation
Collaborator:
Progen Pharmaceuticals
Information provided by (Responsible Party):
Medigen Biotechnology Corporation
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Hepatocellular |
Intervention |
Drug: PI-88 |
Enrollment | 172 |
Participant Flow
Recruitment Details | 215 patients were screened between June 2004 and December 2006. Patients were randomized in balanced blocks per center. |
Pre-assignment Details |
Arm/Group Title | Group A - Untreated Control | Group B - 160 mg PI-88/Day | Group C - 250 mg PI-88/Day |
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untreated control with standard of care | 160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week | 250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week |
Period Title: Overall Study | |||
Started | 58 | 57 | 57 |
Completed | 55 | 51 | 43 |
Not Completed | 3 | 6 | 14 |
Baseline Characteristics
Arm/Group Title | Group A - Untreated Control | Group B - 160 mg PI-88/Day | Group C - 250 mg PI-88/Day | Total | |
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untreated control with standard of care, ITT population | 160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, ITT population | 250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, ITT population | Total of all reporting groups | |
Overall Number of Baseline Participants | 58 | 56 | 54 | 168 | |
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ITT population, defined as all randomized subjects who had received at least one dose of study medication (if in a treatment arm) and who had undergone at least one study visit following randomization, including an abdominal CT scan.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 58 participants | 56 participants | 54 participants | 168 participants | |
54.96 (12.54) | 51.47 (12.57) | 52.41 (12.03) | 52.39 (12.38) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 56 participants | 54 participants | 168 participants | |
Female |
15 25.9%
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10 17.9%
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10 18.5%
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35 20.8%
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Male |
43 74.1%
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46 82.1%
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44 81.5%
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133 79.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Taiwan | Number Analyzed | 58 participants | 56 participants | 54 participants | 168 participants |
58 | 56 | 54 | 168 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Director of Regulatory Affairs and Clinical Development |
Organization: | Progen Pharmaceuticals Ltd |
Phone: | +61 (0)7 38423333 |
EMail: | darrynb@progen-pharma.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medigen Biotechnology Corporation |
ClinicalTrials.gov Identifier: | NCT00247728 |
Other Study ID Numbers: |
MG 002 PR88204 ( Other Identifier: Alternate protocol identifier set by company ) |
First Submitted: | November 1, 2005 |
First Posted: | November 2, 2005 |
Results First Submitted: | July 27, 2011 |
Results First Posted: | November 12, 2020 |
Last Update Posted: | November 12, 2020 |