臨床研究等提出・公開システム

A multi-center, single-arm, open-label phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

OP-724-H201 study

Kimura Kiminori

Tokyo Metropolitan Komagome Hospital

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

kiminori_kimura@tmhp.jp

Ikoma Akemi

Tokyo Metropolitan Komagome Hospital

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

+81-3-4463-7577

akemi_ikoma@tmhp.jp

Complete

Nov. 19, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
1) Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA < 200 copies/mL and CD4 positive T lymphocyte count >= 200 cells/micro-L at screening).
2) Regarding HCV, patients who had passed >= 12 months after achieving SVR at registration.
(2) Patients with Child-Pugh classification A or B (Child-Pugh score 5-9) .
(3) Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
1) Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.
2) Abdominal CT scan shows changes in liver shape and/or portal hypertension.
(4) Patients with Performance Status 0-2 at screening.
(5) Male patients aged 18 to under 75 at the time of obtaining written consent.
(6) Patients who provided voluntary written consent to participate in this study.
(7) Patients who are available for all required visits of this study from screening priod to follow-up priod, judged by the investigator or sub-investigator.

(1) Patients with liver cirrhosis of which cause is not HCV or unknown.
(2) Patients who may use albumin products during this study, such as who are with moderate to severe ascites with resistance to potassium retaining diuretics, loop diuretics, or vasopressin V2 receptor antagonists, who have undergone abdominal paracentesis with refractory ascites, or who are with serum albumin level <= 2.5 g/dL due to hypoalbuminemia etc.
(3) Patients who use branched-chain amino acid(BCAA) products and have not been using them for more than 1 year at the time of registration.
(4) Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
(5) Patients with complications or with previous history of primary liver cancer (excluding patients who have passed for more than 1 year after hepatoma removing operation or radiofrequency ablation etc. for liver cancer).
(6) Patients with complication or history of malignant tumor (within 3 years before registration).
(7) Patients who have positive blood test result for HBV, HTLV-1 or syphilis at screening.
(8) Patients with serum creatinine level at screening > 1.5 times the upper limit of the facility reference value.
(9) Patients with complications with uncontrolled diabetes, hypertension or heart failure.
(10) Patients with psychiatric disorders that may affect the conduct of this study.
(11) Patients with or have a history of serious allergies to contrast agent.
(12) Patients whose dosage and administration have been changed within 3 months prior to registration and/or may change after entering this study, in case of the following treatments have been given.
- Liver cirrhosis
- HIV
(13) Patients with a history of drug or alcohol intoxication within 5 years prior to registration, or patients with a history of drug or alcohol abuse within the last 1 year.
(14) Patients who had either treatment of investigational medical products, devices or materials within 30 days prior to registration.
(15) Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
(16) Patients who have difficulty in intravenous administration.
(17) Patients with active AIDS-indicator disease that require treatment.
(18) Male patients who do not consent to contraception from the time of registration to 12 weeks after the end of investigational medical product administration.
(19) Patients with a history of foscenvivint administration.
(20) In addition, patients who are judged by the investigator or sub-investigator to be ineligible for this study.

Male

Liver cirrhosis caused by HIV/HCV co-infection with hemophilia

Single arm: Foscenvivint will be administered 280 mg/m2 by intravenous (IV) infusion over 3-4 hours twice a week for 24 weeks.

Liver Cirrhosis, HCV, HIV, Hemophilia

CBP/beta-catenin inhibitor

D008103

D060449

Change from baseline in ALBI score at 24 weeks after administration

Change from baseline at each measuring time point in outcomes that are Child-Pugh score, ALBI score, Liver stiffness measurement by FibroScan and Serum fibrosis markers, etc.

+81-3-3823-2101

Oct. 18, 2023

No

none