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A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection

NCT01402908 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2022-06-23

Study results available
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Summary

The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Conditions

Interventions

DRUG

PI-88

Lyophilized powder reconstituted to provide 160 mg of PI-88

OTHER

Placebo

Lactose lyophilized powder

Sponsors & Collaborators

  • Medigen Biotechnology Corporation

    collaborator INDUSTRY

  • Cellxpert Biotechnology Corp.

    lead INDUSTRY

Principal Investigators

  • Pei-Jer Chen, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-07-31
Completion
2015-01-31

Countries

  • China
  • Hong Kong
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01402908 on ClinicalTrials.gov