Liver CirrhosisPhase 2NCT06144086
A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia (OP-724-H201)
A Phase 2 study testing Foscenvivint in people with Liver Cirrhosis, run by Kiminori Kimura, MD at 3 sites in Japan.
Trial summary
This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 74 years, men only
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Foscenvivint
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesJapan
- Study dates
- 8 May 2024to 27 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
- Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA < 200 copies/mL and CD4 positive T lymphocyte count >= 200 cells/µL at screening).
- Regarding HCV, patients who had passed >= 12 months after achieving SVR at registration.
- Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
- Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
- Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.
- Abdominal CT scan shows changes in liver shape and/or portal hypertension.
- Patients with Performance Status 0-2.
Who cannot join
- Patients with liver cirrhosis of which cause is not HCV or unknown.
- Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
- Patients with complication or history of malignant tumor (within 3 years before registration).
- Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
- Patients with active AIDS-indicator disease that require treatment.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, 113-8677
National Hospital Organization Osaka National Hospital
Osaka, Osaka, 540-0006
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
About this study
Official title: A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.
Read the detailed description
This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration.
Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included.
- Conditions
- Liver Cirrhosis
- Being tested
- Foscenvivint
- Keywords
- Liver Cirrhosis, Hemophilia, HIV/HCV co-infection
- Medical subject headings
- Liver Cirrhosis, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoscenvivintDrug
Also called CBP-beta-catenin inhibitor, OP-724, PRI-724 (former name)
Administered by intravenous (IV) infusion over 3-4 hours
| Study group | Role | What they receive |
|---|---|---|
| Foscenvivint | Experimental | Foscenvivint 280 mg/m2, twice a week for 24 weeks Receives: Drug: Foscenvivint |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALBI score
Change from baseline in ALBI score at 24 weeks after administration.
ALBI score = (log10 bilirubin [mg/dL] x 17.1) x 0.66 + (albumin [g/dL] x 10 x -0.085)
Measured: Baseline to 24 weeks after administration
Secondary outcomes (13)
Child-Pugh score
Change from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration.
Child-Pugh score is determined by scoring the following five clinical measures.
Encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points
Ascites: None = 1 point, slight = 2 points, moderate = 3 points
Bilirubin: < 2 mg/dL = 1 point, 2 to 3 mg/dL = 2 points, > 3 mg/dL = 3 points
Albumin: > 3.5 g/dL = 1 point, 2.8 to 3.5 g/dL = 2 points, < 2.8 g/dL = 3 points
Prothrombin Time (%): > 70% = 1 point, 40 to 70% = 2 points, < 40% = 3 points
Measured: Baseline to 12, 24 and 28 weeks after administration
ALBI score
Change from baseline in ALBI score at 12 and 28 weeks after administration.
Measured: Baseline to 12 and 28 weeks after administration
Liver stiffness measurement by FibroScan
Change from baseline in Liver stiffness measurement by FibroScan at 12 and 24 weeks after administration.
Measured: Baseline to 12 and 24 weeks after administration
Serum fibrosis markers
Change from baseline in Serum fibrosis markers at 12 and 24 weeks after administration.
Measured: Baseline to 12 and 24 weeks after administration
Serum albumin
Change from baseline in serum albumin at 12, 24 and 28 weeks after administration.
Measured: Baseline to 12, 24 and 28 weeks after administration
Serum bilirubin
Change from baseline in serum bilirubin at 12, 24 and 28 weeks after administration.
Measured: Baseline to 12, 24 and 28 weeks after administration
PT%
Change from baseline in PT% at 12, 24 and 28 weeks after administration.
Measured: Baseline to 12, 24 and 28 weeks after administration
MELD score
Change from baseline in MELD score at 12, 24 and 28 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. The higher the score, the more serious the subject's disease. MELD is calculated according to the following formula:
MELD score = 3.78 x ln(serum bilirubin [mg/dL]) + 11.2 x ln(PT-INR) + 9.57 x ln(serum creatinine [mg/dL]) + 6.43
Measured: Baseline to 12, 24 and 28 weeks after administration
FIB-4 index
Change from baseline in FIB-4 index at 12, 24 and 28 weeks after administration.
FIB-4 index = (Age [years] x AST [U/L]) / (Platelet Count [10*9/L] x √ ALT [U/L] )
Measured: Baseline to 12, 24 and 28 weeks after administration
mALBI grade
Percentage of subjects who achieved >= 1 stage improvement in mALBI grade from baseline at 12, 24 and 28 weeks after administration.
Based on ALBI score, mALBI grade is classified into Grade 1 to 3 shown below.
mALBI grade: Grade 1: <=-2.60; Grade 2a: >-2.60 to <-2.27; Grade 2b: >=-2.27 to -1.39; Grade 3: >-1.39
Measured: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification
Percentage of subjects who changed from grade B at baseline to grade A at 12, 24 and 28 weeks after administration in Child-Pugh classification.
Based on the total points in Child-Pugh score (scale range 5-15 points, the severity increases sequentially from 5 to 15 points), the severity of the disease is classified into Grade A to C shown below.
Child-Pugh classification:
Grade A: 5 to 6 points -> Compensated cirrhosis; Grade B: 7 to 9 points -> Decompensated cirrhosis; Grade C: 10 to 15 points -> Decompensated cirrhosis
Measured: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh score
Percentage of subjects who achieved >= 2 points improvement from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration.
Measured: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification and score
Percentage of subjects who changed from grade B to grade A in Child-Pugh classification and achieved >= 2 points improvement in Child-Pugh score from baseline at 12, 24 and 28 weeks after administration.
Measured: Baseline to 12, 24 and 28 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start8 May 2024
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiminori Kimura, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Responsible party
- Sponsor-investigator, Kiminori Kimura, MD, Komagome Hospital
- Investigators
- Kiminori Kimura, MD, Principal investigator, Tokyo Metropolitan Komagome Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144086
- Sponsor's protocol ID
- OP-724-H201
- Other IDs
- jRCT2031230461
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
- ClinicalTrials.gov ID
- NCT06144086
- Acronym / sponsor ID
- OP-724-H201
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Hemophilia, HIV/HCV co-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kiminori Kimura, MDUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- 8 May 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.
Detailed description
This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration.
Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foscenvivint | Experimental | Drug: FoscenvivintFoscenvivint 280 mg/m2, twice a week for 24 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
- Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
- Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
- Patients with Performance Status 0-2.
Key exclusion criteria (5 listed)
- Patients with liver cirrhosis of which cause is not HCV or unknown.
- Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
- Patients with complication or history of malignant tumor (within 3 years before registration).
- Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
- Patients with active AIDS-indicator disease that require treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoscenvivintAlso: CBP-beta-catenin inhibitor, OP-724, PRI-724 (former name)Administered by intravenous (IV) infusion over 3-4 hours | Drug | Foscenvivint |
Primary outcome
ALBI score
Time frame: Baseline to 24 weeks after administration
Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin [mg/dL] x 17.1) x 0.66 + (albumin [g/dL] x 10 x -0.085)
13 secondary outcomes
Child-Pugh score
Time frame: Baseline to 12, 24 and 28 weeks after administration
ALBI score
Time frame: Baseline to 12 and 28 weeks after administration
Liver stiffness measurement by FibroScan
Time frame: Baseline to 12 and 24 weeks after administration
Serum fibrosis markers
Time frame: Baseline to 12 and 24 weeks after administration
Serum albumin
Time frame: Baseline to 12, 24 and 28 weeks after administration
Serum bilirubin
Time frame: Baseline to 12, 24 and 28 weeks after administration
PT%
Time frame: Baseline to 12, 24 and 28 weeks after administration
MELD score
Time frame: Baseline to 12, 24 and 28 weeks after administration
FIB-4 index
Time frame: Baseline to 12, 24 and 28 weeks after administration
mALBI grade
Time frame: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification
Time frame: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh score
Time frame: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification and score
Time frame: Baseline to 12, 24 and 28 weeks after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiminori Kimura, MD principal investigator
Tokyo Metropolitan Komagome Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Foscenvivint in people with Liver Cirrhosis, run by Kiminori Kimura, MD at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALBI score (time frame: Baseline to 24 weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.