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Experimental drug aims to reverse liver damage in rare triple condition

NCT ID NCT07681089

Disease control Sponsor: Kiminori Kimura, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This study tests a drug called foscenvivint in people with liver cirrhosis caused by HIV and hepatitis C co-infection who also have hemophilia. Participants receive the drug once a week for 24 weeks. Researchers will check if the drug improves liver function and is safe to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
foscenvivint
What this could lead to
If successful, this could point toward a new treatment option for liver cirrhosis in people with HIV/HCV co-infection and hemophilia.
What could go wrong
This is a very small early-phase trial with only 4 participants, so results may not apply broadly. The drug may not improve liver function or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 4 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria: 1. 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. 2. 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: <!-- --> 1. Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening. 2. 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. Exclusion Criteria: * 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. -

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hemophilia hemophilia A hepatitis C virus infection HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver cirrhosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, Osaka, 540-0006, Japan

  • Tokyo Metropolitan Komagome Hospital

    RECRUITING

    Bunkyo-Ku, Tokyo, 113-8677, Japan

More trials for these conditions

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