Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)

Immunitor LLC1 site in 1 country120 target enrollmentJanuary 2015

ConditionsHepatocellular Carcinoma HCC Liver Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Immunitor LLC
Enrollment: 120
Locations: 1
Primary Endpoint: changes in plasma AFP
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.

Detailed Description

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

December 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Immunitor LLC

Responsible Party

Principal Investigator

Aldar Bourinbaiar

Investigator

Immunitor LLC

Eligibility Criteria

Inclusion Criteria

•Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
•HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan, and AFP serum test higher or equal to 30 IU/ml.
•All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
•Health score status at baseline. Agreement to participate in the study and to give at least 3 samples of blood for lab tests.
•Readily available home or o other address where patient can be found. -

Exclusion Criteria

•Subjects who might have already taken V5 in prior trials and have no baseline data. Those who met inclusion criteria can be retrospectively enrolled. Pregnant or breast-feeding women are excluded.
•Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any locally available immune modulators, and any other therapeutic or preventive HCC vaccine. Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry.
•Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to HCC.
•Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.