PI-88 in Hepatocellular Carcinoma After Hepatectomy

Phase 2 Completed 172 enrolled Cellxpert Biotechnology Corp. Medigen Biotechnology Corporation · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2004-06
Primary completion: 2008-06
Completion: 2008-06

Outcome

Missed primary endpoint

registry analysis (unspecified test); Group A - Untreated Control vs Group B - 160 mg PI-88/Day; p = 0.072; Chi-squared NCT00247728 ↗

registry analysis (unspecified test); Group A - Untreated Control vs Group C - 250 mg PI-88/Day; p = 0.298; Chi-squared NCT00247728 ↗

Publications

Liu CJ, Chang J, Lee PH, Lin DY, Wu CC, Jeng LB, Lin YJ, Mok KT, Lee WC, Yeh HZ, Ho MC, Yang SS, Yang MD, Yu MC, Hu RH, Peng CY, Lai KL, Chang SS, Chen PJ. Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence. World J Gastroenterol. 2014 Aug 28;20(32):11384-93. doi: 10.3748/wjg.v20.i32.11384.
Liu CJ, Lee PH, Lin DY, Wu CC, Jeng LB, Lin PW, Mok KT, Lee WC, Yeh HZ, Ho MC, Yang SS, Lee CC, Yu MC, Hu RH, Peng CY, Lai KL, Chang SS, Chen PJ. Heparanase inhibitor PI-88 as adjuvant therapy for hepatocellular carcinoma after curative resection: a randomized phase II trial for safety and optimal dosage. J Hepatol. 2009 May;50(5):958-68. doi: 10.1016/j.jhep.2008.12.023. Epub 2009 Feb 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	muparfostat	Other / unclassified	160 mg	Subcutaneous
Subject	muparfostat	Other / unclassified	250 mg	Subcutaneous