Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV with Hemophilia.

A Phase 1 study testing OP-724 in people with Liver Cirrhosis, run by Kiminori Kimura, MD at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia. Read more about this study

Who is it for?: Ages 20 to 74 years, men only
Conditions the study is for: Liver Cirrhosis
What is being tested?: OP-724
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteJapan
Study dates: 15 Mar 2021to 5 Jul 2022
Phase: Phase 1
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 20 to 74 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2).
HIV-RNA positive in serum or HIV antibody positive patients (the amount of HIV-RNA in the blood at the time of screening is less than 200 copies/mL, and the number of CD4 positive T lymphocytes can be maintained at 200/micro L or more).
HCV-RNA positive in serum or HCV antibody positive patients (regardless of the amount of viral and treatment).
2. Patients with Child-Pugh class A or B.
3. Patients who meet at least one of 1) to 3) for diagnosis of liver cirrhosis.
FIB-4 index value is 3.25 or higher.

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Liver hardness value by FibroScan is 11.8 kPa or more.
Abdominal CT scan shows changes in liver shape and/or portal hypertension symptoms.
4. Patients who meet any of 1) to 3) for anti-HCV therapy.
Patients who have not reached the sustained virological response (SVR) * with the direct acting antivirals (DAA) therapy. * SVR shall be as SVR12 (persistent virus negative at 12 weeks after the end of administration).
Patients who have difficulty in performing DAA therapy.
Patients who have passed 24 weeks or more after achieving SVR* with DAA therapy or IFN therapy.
5. Patients with Performance Status 0-2.
6. Male patients aged 20 to under 75 at the time of obtaining written consent.
7. Patients who provided voluntary written consent to participate in this clinical trial.

Who cannot join

Patients who have cirrhosis due to causes other than HCV, and patients whose cause of cirrhosis is unknown.
Patients with esophagogastric varices who are judged to require treatment by endoscopy at the time of screening.
Patients with complication or with previous history of primary liver cancer (excluding patients who have been for more than 1 year after hepatoma removing operation or radiofrequency ablation etc.).
Patients with complication or with previous history of malignant tumor (within 3 years before screening).However, except for the following diseases: treated basal cell carcinoma, treated lung carcinoma in situ, or well-controlled superficial (non-invasive) bladder cancer.
Patients with active AIDS index disease requiring treatment.
Patients for whom HBV, HTLV-1 active viral infection or syphilis infection cannot be ruled out.

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Serum creatinine level: Patients over 1.5 times the upper limit of the facility reference value.
Patients with complications with uncontrolled diabetes, hypertension or heart failure.
Patients with psychiatric disorders that may affect the conduct of clinical trial.
Patients with or have a history of serious allergies to contrast agent.
Patients who have not passed the following period at the time of registration and after the end of anti-HCV therapy.
IFN preparation 12 weeks after the last administration
Ribavirin preparation 16 weeks after the last administration
16 weeks after the last administration of DAA
Patients whose dosage and administration have been changed within 12 weeks prior to registration if the following treatments have been given.
Liver cirrhosis
HIV
Patients with a history of drug or alcohol intoxication within 5 years prior to obtaining written consent, or patients with a history of drug or alcohol abuse within the last 1 year.
Patients who participated in other clinical trials within 30 days before obtaining written consent and used or had used investigational drugs or investigational medical devices.
Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation) and patients who have difficulty in intravenous administration.
Male patients who do not consent to contraception from the time of consent acquisition to 12 weeks after the end of study drug administration.
In addition, patients who are judged by the investigator or sub-investigator to be ineligible for this study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, 113-8677

Other trials in Japan

About this study

Official title: Phase I Clinical Trial of CBP/Beta-catenin Inhibitor OP-724 in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia. (OP-724-H101)

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

Read the detailed description

This trial is an uncontrolled, open-label, single-center phase I study in liver cirrhosis patients caused by human immunodeficiency virus (HIV)/hepatitis C virus (HCV) co-infection with hemophilia.

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. OP-724 is intravenously administered twice a week (4 hours) for 12 weeks as an administration schedule.

At 14 days before the administration of the first cycle, the dose planned for the first cycle will be administered once by continuous intravenous administration for 4 hours, and the safety and pharmacokinetics will be evaluated from the day of administration to the day after the administration. If an integrase inhibitor is used in combination as a key drug for antiretroviral drugs, its pharmacokinetics will be evaluated at the same time.

A dose escalation study with 2 doses (cohort 1: 140 mg/m2/4hr (starting dose), cohort 2: 280 mg/m2/4hr) will be conducted, and 3 patients in each cohort will be enrolled. Comprehensively investigate the safety and pharmacokinetic data after OP-724 administration, and evaluate the safety and tolerability of OP-724 administration.

Conditions: Liver Cirrhosis
Being tested: OP-724
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.

OP-724Drug
Also called CBP-beta-catenin inhibitor, PRI-724 (former name)
Twice a week for 4 hours continuous intravenous administration of OP-724.

Study groups in NCT04688034
Study group	Role	What they receive
OP-724 400 mg / 20 mL / vial (20 mg / mL)	Experimental	Dose: [Cohort 1] 140 mg/m2/4 hours (starting dose) , [Cohort 2] 280 mg/m2/4 hours Administration method: In the single administration, the safety of concomitant use with the investigational drug and antiretroviral drug will be confirmed and then the cycle administration will be started. For the single administration, at 14 days before the first cycle of administration, the dose planned for the first cycle with continuous intravenous administration for 4 hours will be administrated once. When an integrase inhibitor is used in combination as a key drug for antiretroviral drugs, it should be administered at the same time as the start of investigational drug administration only after the single administration. For the cycle administration, the continuous intravenous administration for 4 hours twice a week is defined as one cycle, and 12 cycles (12 weeks in total) will be performed. Receives: Drug: OP-724

What is being measured

The primary outcome is the main question the study is designed to answer.

Serious Adverse Events (Side Effects)
Occurrence rate of serious adverse events whose causal relationship with the investigational drug cannot be ruled out (side effects). The data will be aggregated by each cohort.
Measured: 28 days after the last administration of OP-724.

Secondary outcomes (15)

Adverse Events
Occurrence rate of adverse events. The data will be aggregated by each cohort, seriousness and severity.
Measured: 28 days after the last administration of OP-724.
Side Effects
Occurrence rate of side effects.
Measured: 28 days after the last administration of OP-724.
Parameters on Pharmacokinetics (OP-724 and C-82): Maximum Plasma Concentration (Cmax)
Cmax of OP-724 and C-82 will be determined.
Measured: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Parameters on Pharmacokinetics (OP-724 and C-82): Area Under the Curve from 0 to 24 hours (AUC0-24h)
AUC0-24 of OP-724 and C-82 will be determined.
Measured: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Parameters on Pharmacokinetics (OP-724 and C-82): Time to Maximum Plasma Concentration (Tmax)
Tmax of OP-724 and C-82 will be determined.
Measured: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Parameters on Pharmacokinetics (OP-724 and C-82): t1/2
t1/2 of OP-724 and C-82 will be determined.
Measured: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Drug Concentration (OP-724 and C-82) in Plasma
Graphing with time course of drug concentration.
Measured: A) Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours. B) Continuous administration part: pre-dose and post-dose at 4 hours on Day 1 and 4 in Cycle 1, 5, 9 and 12 (each cycle is 7days).
Drug Concentration (Integrase inhibitor) in Plasma
Graphing with time course of drug concentration.
Measured: A) Single administration part: pre-dose and post-dose at 2, 4, 9 and 24 hours. B) Continuous administration part: pre-dose on Day 1 in Cycle 5, 9 and 12 (each cycle is 7days).
Blood HIV-RNA Level
Amount of change in blood HIV-RNA level from baseline at each measurement time point.
Measured: Baseline, Cycle5Day1, Cycle9Day1 and up to 12 weeks after administration (each cycle is 7days).
CD4 Positive T Lymphocyte Count
Amount of change in CD4 positive T lymphocyte count from baseline at each measurement time point.
Measured: Baseline, Cycle5Day1, Cycle9Day1 and up to 12 weeks after administration (each cycle is 7days).
FibroScan
Amount of change from baseline in the measured value of liver tissue hardness by FibroScan at 12 weeks after administration.
Measured: Baseline and 12 weeks after administration
FIB-4 Index
Amount of change from baseline in FIB-4 index at 12 weeks after administration.
Measured: Baseline and 12 weeks after administration
APRI
Amount of change from baseline in APRI at 12 weeks after administration.
Measured: Baseline and 12 weeks after administration
Child-Pugh Score
Amount of change from baseline in Child-Pugh Score at 12 weeks after administration. Child Pugh score (scale range 5-15 points, the severity increases sequentially from 5 to 15 points) is obtained by adding the score for each parameter (hepatic encephalopathy, ascites, bilirubin, albumin, PT). Based on the total points score (Child-Pugh Score) of each diagnostic parameter shown above, the severity of the disease is classified into Grades A to C shown below.
- Grade A: 5-6 points -> Compensated cirrhosis
- Grade B: 7-9 points -> Decompensated cirrhosis
- Grade C: 10-15 points -> Decompensated cirrhosis
Measured: Baseline and 12 weeks after administration
MELD Score
Amount of change from baseline in MELD score at 12 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. MELD is calculated according to the following formula:
- MELD score = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43
Measured: Baseline and 12 weeks after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 20215 Jul 2022

First posted29 Dec 2020
Study start15 Mar 2021
Primary completion5 Jul 2022
Study completion5 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04688034
Sponsor's protocol ID: OP-724-H101
Other IDs: jRCT2031200266
Status last verified: Oct 2024
First submitted: 21 Dec 2020
Last updated: 21 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kimura K, Tanuma J, Kimura M, Imamura J, Yanase M, Ieiri I, Kurosaki M, Watanabe T, Endo T, Yotsuyanagi H, Gatanaga H. Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study. BMJ Open Gastroenterol. 2024 Apr 27;11(1):e001341. doi: 10.1136/bmjgast-2023-001341.
PubMed 38677720

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial of CBP/Beta-catenin Inhibitor OP-724 in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia. (OP-724-H101)
ClinicalTrials.gov ID: NCT04688034
Acronym / sponsor ID: OP-724-H101
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis, Hemophilia, HIV/HCV co-infection
Phase: Phase 1
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, Ohara Pharmaceutical Co., Ltd.
Study start: 15 Mar 2021 (actual)
Primary completion: 5 Jul 2022 (actual)
Study completion: 5 Jul 2022 (actual)
First posted: 29 Dec 2020 (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.

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

Detailed description

This trial is an uncontrolled, open-label, single-center phase I study in liver cirrhosis patients caused by human immunodeficiency virus (HIV)/hepatitis C virus (HCV) co-infection with hemophilia.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OP-724 400 mg / 20 mL / vial (20 mg / mL)	Experimental	Drug: OP-724Dose: [Cohort 1] 140 mg/m2/4 hours (starting dose) , [Cohort 2] 280 mg/m2/4 hours Administration method: In the single administration, the safety of concomitant use with the investigational drug and antiretroviral drug will be confirmed and then the cycle administration will be started. For the single administration, at 14 days before the first cycle of administration, the dose planned for the first cycle with continuous intravenous administration for 4 hours will be administrated once. When an integrase inhibitor is used in combination as a key drug for antiretroviral drugs, it should be administered at the same time as the start of investigational drug administration only after the single administration. For the cycle administration, the continuous intravenous administration for 4 hours twice a week is defined as one cycle, and 12 cycles (12 weeks in total) will be performed.

Who may qualify

Ages: 20 to 74 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

1. Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2).
HIV-RNA positive in serum or HIV antibody positive patients (the amount of HIV-RNA in the blood at the time of screening is less than 200 copies/mL, and the number of CD4 positive T lymphocytes can be maintained at 200/micro L or more).
HCV-RNA positive in serum or HCV antibody positive patients (regardless of the amount of viral and treatment).
2. Patients with Child-Pugh class A or B.
3. Patients who meet at least one of 1) to 3) for diagnosis of liver cirrhosis.

Key exclusion criteria (22 listed)

Patients who have cirrhosis due to causes other than HCV, and patients whose cause of cirrhosis is unknown.
Patients with esophagogastric varices who are judged to require treatment by endoscopy at the time of screening.
Patients with complication or with previous history of primary liver cancer (excluding patients who have been for more than 1 year after hepatoma removing operation or radiofrequency ablation etc.).
Patients with complication or with previous history of malignant tumor (within 3 years before screening).However, except for the following diseases: treated basal cell carcinoma, treated lung carcinoma in situ, or well-controlled superficial (non-invasive) bladder cancer.
Patients with active AIDS index 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
OP-724Also: CBP-beta-catenin inhibitor, PRI-724 (former name)Twice a week for 4 hours continuous intravenous administration of OP-724.	Drug	OP-724 400 mg / 20 mL / vial (20 mg / mL)

Primary outcome

Serious Adverse Events (Side Effects)
Time frame: 28 days after the last administration of OP-724.
Occurrence rate of serious adverse events whose causal relationship with the investigational drug cannot be ruled out (side effects). The data will be aggregated by each cohort.

15 secondary outcomes

Adverse Events
Time frame: 28 days after the last administration of OP-724.
Side Effects
Time frame: 28 days after the last administration of OP-724.
Parameters on Pharmacokinetics (OP-724 and C-82): Maximum Plasma Concentration (Cmax)
Time frame: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Parameters on Pharmacokinetics (OP-724 and C-82): Area Under the Curve from 0 to 24 hours (AUC0-24h)
Time frame: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Parameters on Pharmacokinetics (OP-724 and C-82): Time to Maximum Plasma Concentration (Tmax)
Time frame: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Parameters on Pharmacokinetics (OP-724 and C-82): t1/2
Time frame: Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.
Drug Concentration (OP-724 and C-82) in Plasma
Time frame: A) Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours. B) Continuous administration part: pre-dose and post-dose at 4 hours on Day 1 and 4 in Cycle 1, 5, 9 and 12 (each cycle is 7days).
Drug Concentration (Integrase inhibitor) in Plasma
Time frame: A) Single administration part: pre-dose and post-dose at 2, 4, 9 and 24 hours. B) Continuous administration part: pre-dose on Day 1 in Cycle 5, 9 and 12 (each cycle is 7days).
Blood HIV-RNA Level
Time frame: Baseline, Cycle5Day1, Cycle9Day1 and up to 12 weeks after administration (each cycle is 7days).
CD4 Positive T Lymphocyte Count
Time frame: Baseline, Cycle5Day1, Cycle9Day1 and up to 12 weeks after administration (each cycle is 7days).
FibroScan
Time frame: Baseline and 12 weeks after administration
FIB-4 Index
Time frame: Baseline and 12 weeks after administration
APRI
Time frame: Baseline and 12 weeks after administration
Child-Pugh Score
Time frame: Baseline and 12 weeks after administration
MELD Score
Time frame: Baseline and 12 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 21 Oct 2024.
Derived from this study: PubMed 38677720Kimura K, Tanuma J, Kimura M, Imamura J, Yanase M, Ieiri I, Kurosaki M, Watanabe T, Endo T, Yotsuyanagi H, Gatanaga H. Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study. BMJ Open Gastroenterol. 2024 Apr 27;11(1):e001341. doi: 10.1136/bmjgast-2023-001341.
Individual participant dataSharing planned: No

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OP-724 in people with Liver Cirrhosis, run by Kiminori Kimura, MD at 1 site 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 15 inclusion and 22 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Serious Adverse Events (Side Effects) (time frame: 28 days after the last administration of OP-724.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688034, which also lists 1 linked publication.

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 21 Oct 2024.