At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 172 enrolled
Drug / intervention
PI-88drug
Likely dose
PI-88, once-daily subcutaneous injection for four consecutive days per week, for 3 weeks out of every 4 weeksAI-extracted
Key inclusion· 5
- ✓Age ≥18 and ≤75 years
- ✓Histologically confirmed hepatocellular carcinoma
- ✓Curative hepatectomy performed 4–6 weeks before enrollment
- ✓ECOG performance status 0–2
Key exclusion· 11
- ✕History of allergy or hypersensitivity to anticoagulants/thrombolytic agents, especially heparin
- ✕History of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or other platelet disease
- ✕Previous positive heparin-induced thrombocytopenia (HIT) antibody test
- ✕Any tumor metastasis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
In Brief
A Phase 2 clinical trial evaluating PI-88 for Carcinoma, Hepatocellular. Completed, enrolled 172 participants across 6 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesTaiwan
CollaboratorsMedigen Biotechnology Corporation
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
First PostedNov 2005
Primary CompletionJun 2008
TodayJul 2026
First PostedNov 2, 2005
Enrollment StartJun 1, 2004
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.7 years ago
Interventions
PI-88drug
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks