Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478719
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
Sponsor:
Febico Biomedical Corp
Organization:
Febico Biomedical Corp
Study Overview
Official Title:
A Phase III Randomized Double-blinded Study of FB-1603 to Evaluate the Safety and Efficacy in Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization FECHT Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
None
Brief Summary:
The goal of this clinical trial is to assess the efficacy of FB-1603 on improving liver function impairment in hepatocellular carcinoma patients receiving transarterial chemoembolization The main question it aims to answer is
Changes in the level of liver function parameters including AST ALT or total bilirubin from baseline to Visit 3 Visit 4 Visit 5 and Visit 6
There is a comparison group Researchers will compare arm 1 placebo to see if FB-1603 is work to treat the liver function
Participants will
1 Take drug FB-1603 990mgday FB-1603 1980mgday or a placebo every day for 10 weeks
2 Visit the clinic on day 4 7 10 14 28 56 and 84 follow-up
Changes in the level of liver function parameters including AST ALT or total bilirubin from baseline to Visit 3 Visit 4 Visit 5 and Visit 6
There is a comparison group Researchers will compare arm 1 placebo to see if FB-1603 is work to treat the liver function
Participants will
1 Take drug FB-1603 990mgday FB-1603 1980mgday or a placebo every day for 10 weeks
2 Visit the clinic on day 4 7 10 14 28 56 and 84 follow-up
Detailed Description:
I Objectives
Primary objective To assess the efficacy of FB-1603 on improving liver function impairment after transarterial chemoembolization TACE in subjects
Secondary objective
To evaluate the safety of FB-1603 in subjects
To evaluate selected parameters indicative of clinical efficacy
To assess postembolization syndrome improvement of FB-1603 compared with placebo
To evaluate virologic test level of FB-1603 compared with placebo
To assess liver stiffness change of FB-1603 compared with placebo
Exploratory objective
To assess the antioxidation activity of FB-1603 in hepatocellular carcinoma HCC subjects after TACE
II Investigational product
1 Name FB-1603 oral capsule FB-1603
2 Dosage form 165 mg oral capsule
3 Doses Each arm consisted of 40 subjects
Arm 1 4Placebo each time TID three times a Day two weeks before and eight weeks after TACE
Arm 2 2FB-1603 165 mg oral capsule and 2Placebo each time TID 990 mgday two weeks before and eight weeks after TACE
Arm 3 4FB-1603 165 mg oral capsule each time TID 1980 mgday two weeks before and eight weeks after TACE
4 Dosing schedule
All enrolled subjects will be randomly assigned 111 to receive low dose 990 mgday high dose 1980 mgday of FB-1603 165 mg oral capsule or placebo capsule three times a day for 10 weeks Each subject starts receiving FB-1603 165 mg oral capsule or placebo capsule on two weeks before and eight weeks after TACE The investigational drugs should be taken orally about 10 minutes before the breakfast lunch and dinner
5 Mechanism of action
The proposed mechanism is that FB-1603 can improve liver function via decrease of oxidative stress In previous study conducted in diethylnitrosamine DEN induced liver cirrhosis and cancer rat model Report FENTU30SEP2009 shown that the extent of oxidative stress determined by NBT Nitro blue tetrazolium staining was significant decreased in treatment group orally administrated with 08 1 or 2 gkgday of FB-1603 compared with the control group
III Developmental phase phase I and II
IV Study design
1 placebo control study
2 Blinding double blind
3 Randomized yes
4 Parallel
5 Duration of treatment days 10 weeks months years
6 Titration forced
7 Single center
VI Study procedures
This is a randomized double-blind 10-week dose-finding study in 3 parallel arms
The study is conducted as follows eligible subjects are randomized parallelly into 3 arms Each arm comprises 40 subjects orally receive active FB-1603 165 mg oral capsule or placebo placebo capsule two weeks before and eight weeks after TACE Each subject will begin receiving FB-1603 oral capsule or placebo two weeks before TACE As the appearance of the placebo capsule is identical to the FB-1603 165 mg oral capsule study blinding will be maintained during the administration procedure Other than staff involved in randomization the sponsor participants and staff involved in the preparation of the study drug are blinded Each subject is assigned to either active FB-1603 165 mg oral capsule or placebo treatment using a block randomization algorithm Three times a day TID doses of FB-1603 165 mg oral capsule are escalated capsule low dose 990 mgday and high dose 1980 mgday
Primary objective To assess the efficacy of FB-1603 on improving liver function impairment after transarterial chemoembolization TACE in subjects
Secondary objective
To evaluate the safety of FB-1603 in subjects
To evaluate selected parameters indicative of clinical efficacy
To assess postembolization syndrome improvement of FB-1603 compared with placebo
To evaluate virologic test level of FB-1603 compared with placebo
To assess liver stiffness change of FB-1603 compared with placebo
Exploratory objective
To assess the antioxidation activity of FB-1603 in hepatocellular carcinoma HCC subjects after TACE
II Investigational product
1 Name FB-1603 oral capsule FB-1603
2 Dosage form 165 mg oral capsule
3 Doses Each arm consisted of 40 subjects
Arm 1 4Placebo each time TID three times a Day two weeks before and eight weeks after TACE
Arm 2 2FB-1603 165 mg oral capsule and 2Placebo each time TID 990 mgday two weeks before and eight weeks after TACE
Arm 3 4FB-1603 165 mg oral capsule each time TID 1980 mgday two weeks before and eight weeks after TACE
4 Dosing schedule
All enrolled subjects will be randomly assigned 111 to receive low dose 990 mgday high dose 1980 mgday of FB-1603 165 mg oral capsule or placebo capsule three times a day for 10 weeks Each subject starts receiving FB-1603 165 mg oral capsule or placebo capsule on two weeks before and eight weeks after TACE The investigational drugs should be taken orally about 10 minutes before the breakfast lunch and dinner
5 Mechanism of action
The proposed mechanism is that FB-1603 can improve liver function via decrease of oxidative stress In previous study conducted in diethylnitrosamine DEN induced liver cirrhosis and cancer rat model Report FENTU30SEP2009 shown that the extent of oxidative stress determined by NBT Nitro blue tetrazolium staining was significant decreased in treatment group orally administrated with 08 1 or 2 gkgday of FB-1603 compared with the control group
III Developmental phase phase I and II
IV Study design
1 placebo control study
2 Blinding double blind
3 Randomized yes
4 Parallel
5 Duration of treatment days 10 weeks months years
6 Titration forced
7 Single center
VI Study procedures
This is a randomized double-blind 10-week dose-finding study in 3 parallel arms
The study is conducted as follows eligible subjects are randomized parallelly into 3 arms Each arm comprises 40 subjects orally receive active FB-1603 165 mg oral capsule or placebo placebo capsule two weeks before and eight weeks after TACE Each subject will begin receiving FB-1603 oral capsule or placebo two weeks before TACE As the appearance of the placebo capsule is identical to the FB-1603 165 mg oral capsule study blinding will be maintained during the administration procedure Other than staff involved in randomization the sponsor participants and staff involved in the preparation of the study drug are blinded Each subject is assigned to either active FB-1603 165 mg oral capsule or placebo treatment using a block randomization algorithm Three times a day TID doses of FB-1603 165 mg oral capsule are escalated capsule low dose 990 mgday and high dose 1980 mgday
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