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Hepatitis CPhase 1/2NCT03620474

Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis

A Phase 1/2 study testing PRI-724 in people with Hepatitis C and Hepatitis B, run by Kiminori Kimura, MD at 3 sites in Japan.

Completed

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

Official record
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Trial summary

To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Hepatitis C, Hepatitis B, Liver Cirrhoses
What is being tested?
PRI-724
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesJapan
Study dates
24 Jul 2018to 28 Feb 2022
Phase
Phase 1/2
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with liver cirrhosis caused by HCV or HBV that satisfies the following (1) or (2) and satisfies (3)
  • Patients with serum HCV-RNA positive or HCV antibody positive
  • Patients with serum HBV-DNA positive or HBs antigen positive
  • confirmed liver cirrhosis by liver biopsy performed in the screening period patients who received diagnosis
  • Patients with Child-Pugh classification in A or B status
  • Patients who satisfy HCV cirrhosis from (1) to (3), HBV cirrhosis (4) In the case of HCV cirrhosis;
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  • Patients who have not reached SVR * with DAA therapy
  • Patients who are difficult to implement DAA therapy
  • Patients who have been over 24 weeks after achieving SVR * with DAA therapy In case of HBV cirrhosis;
  • Patients who have been at least 24 weeks since the start of administration of Nucleotide analogue * SVR is SVR 12 (sustained virological response at 12 weeks after the end of administration).
  • Patients with Performance Status 0 to 2
  • Patients aged 20 years or over and under 75 when acquiring informed consent
  • Regarding participation in this trial (including liver biopsy), patients who obtained informed consent by their own voluntary intention

Who cannot join

  • Patients with HCV and HBV co-infection, patients who came to cirrhosis due to causes other than HCV or HBV, or patients whose cause of cirrhosis is unknown
  • Patients with esophageal gastric varices determined to be treated by endoscopic examination at screening
  • Patients with complication or previous history of primary liver cancer (excluding those who have had more than one year of hepatocarcinoma resection / radiofrequency ablation)
  • Merger of malignant tumor or past patients (within 3 years before screening). However, the following diseases are excluded: treated basal cell carcinoma, treated lung intraepithelial carcinoma, treated cervical carcinoma, or control superficial (not invasive) bladder carcinoma
  • Patients who can not be denied HIV, HTLV-1 or syphilis
  • Serum creatinine value: Patients with more than 1.5 times the upper limit of the facility reference value
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  • Patients with poor control of diabetes, hypertension or heart failure
  • Patients with psychiatric diseases judged to have the potential to influence the implementation of clinical trials
  • Patients who have severe allergy to or contrast media
  • Patients with HCV who have not passed the following period after treatment for HCV cirrhosis at registration.
  • 12 weeks after the final administration of interferon
  • 16 weeks after final administration of Ribavirin
  • 16 weeks after final administration of DAA
  • Patients whose dosage regimen was changed within 12 weeks prior to enrollment
  • Patients who have history of drug or alcohol intoxication within 5 years before acquiring informed consent or who have history of drug or alcohol abuse within the past year
  • Patients who participated in other clinical trials and clinical trials within 30 days prior to acquisition of consent, patients who used investigational drugs or investigational equipment
  • Patients who received liver transplantation or other organ transplantation (including bone marrow transplantation) and patients who are difficult to intravenously administer
  • Patients whose liver biopsy is expected to be difficult to perform
  • Patients who are pregnant or nursing, or who are likely to become pregnant
  • Male patients who do not obtain consent to contraception from the time of acquiring informed consent until the end of 12 weeks after the administration of investigational drug
  • In addition, patients investigated by investigators or clinical trial doctors as judged unsuitable for this trial

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Kohnodai Hospital, National Center for Global Health and Medicine

    Ichikawa, Chiba, 272-8516

Other trials in Japan

About this study

Official title: Phase I / IIa Clinical Trial for Patients With Hepatitis C or B Virus Derived Liver Cirrhosis by CBP / β Catenin Inhibitor PRI-724

To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.

Read the detailed description

【Phase I Phase】 To evaluate safety and pharmacokinetics when PRI-724 is administered to patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724.

【Phase IIa phase】 To evaluate the efficacy and safety of the recommended dose of PRI-724 administered to patients with HCV or HBV liver cirrhosis.

Being tested
PRI-724
Keywords
Hepatitis C virus, Hepatitis B virus, liver Cirrhosis
Medical subject headings
Hepatitis C, Hepatitis B, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRI-724Drug

    Also called CBP-b-catenin inhibitor

    twice a week for 4 hours continuous intravenous administration of PRI-724

Study groups in NCT03620474
Study groupRoleWhat they receive
PRI-724ExperimentalDose: 140, 280, 380 mg / m 2/4 hr Administration method: 【Phase I Phase】 (Level 1) 140 mg / m 2/4 hr (Level 2) 280 mg / m 2/4 hr (Level 3) 380 mg / m 2/4 hr Twice weekly, continuous 4-hour intravenous administration (tolerance of administration time: ± 15 minutes). This is one cycle and 12 cycles (12 weeks in total) are carried out. However, in Phase I phase, single dose is administered on Day - 7 (tolerance: - 7 days). 【Phase IIa phase】 Continuous intravenous administration for 4 hours twice a week at the recommended dose determined in Phase I. This is one cycle and 12 cycles (12 weeks in total) are carried out.
Receives: Drug: PRI-724

What is being measured

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

  1. Serious side effect expression rate

    (Phase I)Serious side effect expression rate

    Measured: 12 weeks after administration

  2. liver tissue fibrosis area ratio by liver biopsy

    (Phase II) Amount of change from the baseline in liver tissue fibrosis area ratio by liver biopsy at 12 weeks after administration

    Measured: 12 weeks after administration

Secondary outcomes (7)

  1. Adverse Event Expression Ratio

    Adverse Event Expression Ratio after PRI-724 treatment

    Measured: 12 weeks after administration

  2. Percentage of occurrence of side effects

    Percentage of occurrence of side effects after PRI-724 treatment

    Measured: 12 weeks after administration

  3. Pharmacokinetic parameter

    Maximum Plasma Concentration (Cmax)

    Measured: 12 weeks after administration

  4. liver stiffness from Fibro Scan

    Amount of change from measurement of liver stiffness by baseline from Fibro Scan at 12 weeks after administration

    Measured: 12 weeks after administration

  5. Child Pugh score

    Amount of change from baseline of Child-Pugh Score at 12 weeks after administration Child Pugh score (scale range 5-15) is obtained by adding the score for each parameter (encephalopathy, ascites, bilirubin, albumin, PT or INR).

    Measured: 12 weeks after administration

  6. MELD score

    Amount of change from baseline for 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 = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43

    Measured: 12 weeks after administration

  7. modified Histological Activity Index (HAI) by liver biopsy

    Change amount from baseline of modified Histological Activity Index (HAI) by liver biopsy at 12 weeks after administration

    Measured: 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.

  1. First posted8 Aug 2018
  2. Study start24 Jul 2018
  3. Primary completion13 Jul 2021
  4. Study completion28 Feb 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620474
Sponsor's protocol ID
PRI-724-2101
Other IDs
UMIN000033369
Status last verified
Oct 2024
First submitted
13 Jul 2018
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kimura K, Kanto T, Shimoda S, Harada K, Kimura M, Nishikawa K, Imamura J, Ogawa E, Saio M, Ikura Y, Okusaka T, Inoue K, Ishikawa T, Ieiri I, Kishimoto J, Todaka K, Kamisawa T. Safety, tolerability, and anti-fibrotic efficacy of the CBP/beta-catenin inhibitor PRI-724 in patients with hepatitis C and B virus-induced liver cirrhosis: An investigator-initiated, open-label, non-randomised, multicentre, phase 1/2a study. EBioMedicine. 2022 Jun;80:104069. doi: 10.1016/j.ebiom.2022.104069. Epub 2022 May 20.

    PubMed 35605429

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRI-724 in people with Hepatitis C and Hepatitis B, 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 13 inclusion and 21 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 10 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 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 combined 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.

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?

Serious side effect expression rate (time frame: 12 weeks after administration). The study lists 2 primary outcomes in all. 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 NCT03620474, 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 10 Oct 2024.

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