Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02232490
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2014-09-03
Brief Title:
Liver Cancer Immunotherapy Placebo-controlled Clinical Trial of Hepcortespenlisimut-L
Sponsor:
Immunitor LLC
Organization:
Immunitor LLC
Study Overview
Official Title:
Phase III Randomized Placebo-controlled Clinical Trial of Hepcortespenlisimut-L Hepko-V5 Versus Placebo in Patients With Advanced Hepatocellular Carcinoma HCC
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hepko-V5
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IMM05 | OTHER | Immunitor | None |