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Trial record 3 of 16 for:    immunitor

Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5)

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ClinicalTrials.gov Identifier: NCT02232490
Recruitment Status : Unknown
Verified February 2019 by Aldar Bourinbaiar, Immunitor LLC.
Recruitment status was:  Recruiting
First Posted : September 5, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Aldar Bourinbaiar, Immunitor LLC

Tracking Information
First Submitted Date  ICMJE September 3, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
changes in plasma AFP [ Time Frame: 3 months ]
Changes in plasma AFP levels at monthly intervals
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
CT scan [ Time Frame: 3 months ]
changes in tumor size/mumber at 3 months compared to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2014)
adverse effects [ Time Frame: 3 months ]
evaluation of adverse effects if any
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L
Official Title  ICMJE Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • HCC
  • Liver Cancer
Intervention  ICMJE
  • Biological: hepcortespenlisimut-L
    hepcortespenlisimut-L (V5) is given in experimental arm
    Other Name: V5
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: hepcortespenlisimut-L
    Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC
    Intervention: Biological: hepcortespenlisimut-L
  • Placebo Comparator: placebo
    placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2014)
100
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mongolia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232490
Other Study ID Numbers  ICMJE Immunitor Hepko-V5
IMM05 ( Other Identifier: Immunitor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: DATA TO BE SHARED WITH COLLABORATORS
Responsible Party Aldar Bourinbaiar, Immunitor LLC
Study Sponsor  ICMJE Immunitor LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: aldar bourinbaiar Immunitor LLC
PRS Account Immunitor LLC
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP