Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03620474|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Hepatitis B Liver Cirrhoses||Drug: PRI-724||Phase 1 Phase 2|
【Phase I Phase】 To evaluate safety and pharmacokinetics when PRI-724 is administered to patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724.
【Phase IIa phase】 To evaluate the efficacy and safety of the recommended dose of PRI-724 administered to patients with HCV or HBV liver cirrhosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I / IIa Clinical Trial for Patients With Hepatitis C or B Virus Derived Liver Cirrhosis by CBP / β Catenin Inhibitor PRI-724|
|Actual Study Start Date :||July 24, 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||July 2020|
Dose: 140, 280, 380 mg / m 2/4 hr
【Phase I Phase】 (Level 1) 140 mg / m 2/4 hr (Level 2) 280 mg / m 2/4 hr (Level 3) 380 mg / m 2/4 hr Twice weekly, continuous 4-hour intravenous administration (tolerance of administration time: ± 15 minutes). This is one cycle and 12 cycles (12 weeks in total) are carried out. However, in Phase I phase, single dose is administered on Day - 7 (tolerance: - 7 days).
【Phase IIa phase】 Continuous intravenous administration for 4 hours twice a week at the recommended dose determined in Phase I. This is one cycle and 12 cycles (12 weeks in total) are carried out.
twice a week for 4 hours continuous intravenous administration of PRI-724
Other Name: CBP-b-catenin inhibitor
- Serious side effect expression rate [ Time Frame: 12 weeks after administration ](Phase I)Serious side effect expression rate
- liver tissue fibrosis area ratio by liver biopsy [ Time Frame: 12 weeks after administration ](Phase II) Amount of change from the baseline in liver tissue fibrosis area ratio by liver biopsy at 12 weeks after administration
- Adverse Event Expression Ratio [ Time Frame: 12 weeks after administration ]Adverse Event Expression Ratio after PRI-724 treatment
- Percentage of occurrence of side effects [ Time Frame: 12 weeks after administration ]Percentage of occurrence of side effects after PRI-724 treatment
- Pharmacokinetic parameter [ Time Frame: 12 weeks after administration ]Maximum Plasma Concentration (Cmax)
- liver stiffness from Fibro Scan [ Time Frame: 12 weeks after administration ]Amount of change from measurement of liver stiffness by baseline from Fibro Scan at 12 weeks after administration
- Child Pugh score [ Time Frame: 12 weeks after administration ]Amount of change from baseline of Child-Pugh Score at 12 weeks after administration Child Pugh score (scale range 5-15) is obtained by adding the score for each parameter (encephalopathy, ascites, bilirubin, albumin, PT or INR).
- MELD score [ Time Frame: 12 weeks after administration ]
Amount of change from baseline for MELD score at 12 weeks after administration
The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula:
MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43
- modified Histological Activity Index (HAI) by liver biopsy [ Time Frame: 12 weeks after administration ]Change amount from baseline of modified Histological Activity Index (HAI) by liver biopsy at 12 weeks after administration
- Serum fibrosis marker level(s) [ Time Frame: 12 weeks after administration ]Changes of level
- Ascitic fluid level [ Time Frame: 12 weeks after administration ]Changes of level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620474
|Contact: Kiminori Kimura, MDemail@example.com|
|Contact: Akemi Ikomafirstname.lastname@example.org|
|Tokyo Metropolitan Komagome Hospital||Recruiting|
|Bunkyō-Ku, Tokyo, Japan, 113-8677|
|Contact: Kiminori Kimura +81-3-3823-2101 email@example.com|
|Contact: Akemi Ikoma +81-3-3823-2101 firstname.lastname@example.org|
|Principal Investigator:||Kiminori Kimura, MD||Komagome Hospital|