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Tiny trial hopes drug can ease liver damage in rare triple condition

NCT ID NCT06144086

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 2 trial tested a drug called foscenvivint in just 5 people with liver cirrhosis caused by HIV and hepatitis C co-infection who also have hemophilia. The goal was to see if the drug could improve liver function scores over 24 weeks. Because the study is very small and early, the results are uncertain but may guide future research.

What this could mean

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

Active substance
foscenvivint (a drug given by IV infusion)
What this could lead to
If it works, this could point toward a treatment to improve liver function in people with cirrhosis from HIV/HCV co-infection and hemophilia.
What could go wrong
This is a very small, early-phase trial with only 5 participants, so results may not apply to others. 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

5 people

The number who actually took part.

Started

May 2024

Finished

Mar 2025

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 74 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.

Key Inclusion Criteria * 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/µL at screening). 2. 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: 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. * Patients with Performance Status 0-2. Key Exclusion Criteria * 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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hemophilia A

As listed by the trial registrant

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

Liver cirrhosis

Contacts and locations

Locations

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006, Japan

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-Ku, Tokyo, 113-8677, Japan

More trials for these conditions

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