Liver CirrhosisPhase 2OP-724-H202NCT07681089
A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
A Phase 2 study testing Foscenvivint in people with Liver Cirrhosis, run by Kiminori Kimura, MD at 4 sites in Japan.
Trial summary
This is a phase 2 study to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia. Read more about this study
- Who is it for?
- Ages 18 to 79 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
- 7 participants
- Where
- 4 sitesJapan
- Study dates
- 1 Oct 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:
- Patients who are serum HIV-RNA positive or HIV antibody positive, with HIV-RNA maintained at <200 copies/mL and a CD4-positive T lymphocyte count of ≥200 cells/µL at screening.
- Patients with HCV infection who have achieved sustained virologic response (SVR) at least 12 months before registration.
- Patients with Child-Pugh class A or B liver cirrhosis (Child-Pugh score 5-9).
- Patients who meet at least one of the following criteria for the diagnosis of liver cirrhosis:
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- Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
- Abdominal CT showing changes in liver morphology and/or findings suggestive of portal hypertension.
- Patients with an Eastern Cooperative Oncology Group Performance Status of 0-2.
Who cannot join
- Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
- Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.
- Patients with current malignancy or a history of malignancy within 3 years before registration.
- Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.
- Patients with active AIDS-defining disease requiring treatment. -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan4 sites, 4 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, 113-8677
Kiminori Kimura, MD, +81-3-3823-2101, kiminori_kimura@tmhp.jp
Akemi Ikoma, +81-3-3823-2101, akemi_ikoma@tmhp.jp
- Recruiting
National Hospital Organization Osaka National Hospital
Osaka, Osaka, 540-0006
Ryotaro Sakamori, MD, +81-6-6942-1331, sakamori@gh.med.osaka-u.ac.jp
Ryotaro Sakamori, MD
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tomoyuki Endo, MD, +81-11-716-1161, t-endo@med.hokudai.ac.jp
Tomoyuki Endo, MD
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520
Junji Imamura, MD, +81-22-293-1111, imamura.junji.ua@mail.hosp.go.jp
About this study
Official title: A Multicenter, Single-Arm, Open-Label Phase 2 Study of Once-Weekly Foscenvivint in Patients With Liver Cirrhosis Due to HIV/HCV Co-infection in the Setting of Hemophilia
This is a phase 2 study to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
Read the detailed description
This is a multicenter, single-arm, open-label phase 2 study of foscenvivint administered intravenously once-weekly for 24 weeks. A follow-up visit will be conducted 4 weeks after the final administration.
Eligible patients are those with Child-Pugh class A or B liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
- 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)
Experimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Foscenvivint | Experimental | Foscenvivint 280 mg/m2, once 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Oct 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
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
- Model description
- Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiminori Kimura, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development, Ohara Pharmaceutical Co., Ltd.
- 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
- NCT07681089
- Sponsor's protocol ID
- OP-724-H202
- Other IDs
- jRCT2031260207
- Acronym
- OP-724-H202
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open-Label Phase 2 Study of Once-Weekly Foscenvivint in Patients With Liver Cirrhosis Due to HIV/HCV Co-infection in the Setting of Hemophilia
- ClinicalTrials.gov ID
- NCT07681089
- Acronym / sponsor ID
- OP-724-H202 / OP-724-H202
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Hemophilia, HIV/HCV co-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Kiminori Kimura, MDUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development, Ohara Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Jul 2026 (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 study to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
Detailed description
This is a multicenter, single-arm, open-label phase 2 study of foscenvivint administered intravenously once-weekly for 24 weeks. A follow-up visit will be conducted 4 weeks after the final administration.
Eligible patients are those with Child-Pugh class A or B liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
| Arm | Type | Receives |
|---|---|---|
| Foscenvivint | Experimental | Drug: FoscenvivintFoscenvivint 280 mg/m2, once a week for 24 weeks |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:
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Key exclusion criteria (5 listed)
- Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
- Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.
- Patients with current malignancy or a history of malignancy within 3 years before registration.
- Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.
- Patients with active AIDS-defining disease requiring 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)Experimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks | 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
Kiminori Kimura, MD principal investigator
Tokyo Metropolitan Komagome Hospital
4 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 4 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 9 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiminori Kimura, MD (+81-3-3823-2101, kiminori_kimura@tmhp.jp), or a site near the patient. 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 5 Oct 2026.