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CompletedNCT02195440Updated Jul 7, 2022

An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis

A Phase 1 interventional study of PRI-724 in Hepatitis C Virus-infected Cirrhosis, sponsored by Komagome Hospital. Completed at 1 site in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-07-07.

Sponsored by Komagome Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
20 Years to 74 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis.

Read the detailed description

This is a single-center, open-label, continuous i.v. administration, dose escalation Phase I study in patients with hepatitis C cirrhosis.

One cycle consisted of one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. One cohort was a total of six cycles, a 12-week treatment period.

PRI-724 was administered at a dose of 10 mg/m2/day in Cohort 1, 40 mg/m2/day in Cohort 2, and 160 mg/m2/day in Cohort 3 in a dose escalation manner. Each cohort was to include 6 subjects.

02

Conditions studied

  • Hepatitis C Virus-infected Cirrhosis

Keywords

  • Hepatitis C virus, cirrhosis
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 14 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Komagome Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Presence of cirrhosis due to hepatitis C virus. 1) Serum HCV-RNA test positive 2) Definitive diagnosis of cirrhosis established by liver biopsy (HAI score: Grade IV-D).
  2. Child-Pugh Class A or B at the time of informed consent, with no likelihood of improvement with existing medical treatment.
  3. Performance Status: 0 - 2.
  4. Between =>20 and \<75 years of age at the time of providing written consent.
  5. Having provided voluntary written consent for participation in this study.
  6. Esophageal and gastric varices are well controlled

Exclusion criteria

Exclusion Criteria:

  1. Patients with cirrhosis due to causes other than hepatitis C virus; or patients with cirrhosis due to unknown causes.
  2. Patients with a history of primary liver cancer or a complication thereof.
  3. Patients with a complication of malignant tumor or a history thereof (within 5 years prior to screening).
  4. Patients in whom such active viral infections as HBV, HIV or ATCL or syphilis infection cannot be ruled out.
  5. Patients with serum creatinine >1.5 times over upper normal or creatinine clearance =\<60 mL/min/1.73 m2.
  6. Patients with hemoglobin \<8 g/dL.
  7. Patients with platelet count \<50,000 /\µL.
  8. Patients with T.Bil =>3.0 mg/dL.
  9. Patients with a complication of poorly controlled diabetes, hypertension or heart failure.
  10. Patients with a complication of mental disorder requiring treatment.
  11. Patients with serious allergy to contrast media or a history thereof.
  12. Patients with allergy to inactive ingredients of the study drug.
  13. Patients who have received interferon, ribavirin or anti-HCV agents within 12 weeks before registration in this study.
  14. When the medical treatment to a primary disease is carried out, Patient who was changed the dosage and administration within the 12 weeks before registration.
  15. Patients with a history of drug or alcohol addiction within five years at the time of providing written consent or a history of drug or alcohol abuse within the past one year.
  16. The patient who received a liver transplant or other organ transplants (a bone marrow transplantation is included), and the patient for whom intravenous administration and venous access are difficult.
  17. Patients contraindicated for liver biopsy.
  18. Female patients who are pregnant or suspected to be pregnant; or those who desire to get pregnant during the study period or those of childbearing potential.
  19. Male patients who do not consent to practice birth control during the clinical study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    PRI-724

    3 cohorts (PRI-724: 10, 40, 160 mg/m2/day), 6 cycles (1 cycle: 1-week continuous i.v. administration+1-week observation period) \*Cycle 2 will not be started until plasma drug concentrations of PRI-724 and C-82 on Days 1 and 2 in Cycle 1 are confirmed. Cohort 1: 10 mg/m2/day (6 subjects) Cohort 2: 40 mg/m2/day (6 subjects) Cohort 3: 160 mg/m2/day (6 subjects) One cycle consists of 1-week continuous i.v. administration of PRI-724 followed by a 1-week observation period. The tolerability and safety after 6 cycles will be confirmed.

    Drug: PRI-724

Interventions

  • DrugPRI-724

    10 - 160 mg/m2, 7 days CIV (in the vein) with 7 days rest per one cycle. Number of Cycles: 6.

    Also known as: CBP-beta-catennin inhibitor, OP-724

06

What researchers measure

Primary outcomes

  1. Adverse events and adverse drug reactions (including subjective symptoms and abnormal laboratory values)

    Items and ratio%

    Time frame: 12 weeks after the initiation of PRI-724 administration

Secondary outcomes

  1. Child-Pugh Score

    Changes of score

    Time frame: 12 weeks after the initiation of PRI-724 administration

  2. Liver biopsy: Histology Activity Index (HAI)

    Changes of index

    Time frame: 12 weeks after the initiation of PRI-724 administration

  3. Serum albumin level

    Changes of level

    Time frame: 12 weeks after the initiation of PRI-724 administration

  4. Serum fibrosis marker level(s)

    Changes of level

    Time frame: 12 weeks after the initiation of PRI-724 administration

  5. Ascitic fluid level

    Changes of level

    Time frame: 12 weeks after the initiation of PRI-724 administration

  6. Improvement rate of lower leg edema

    Changes of rate

    Time frame: 12 weeks after the initiation of PRI-724 administration

  7. Assessment of Area under the plasma concentration versus time curve (AUCinf) of PRI-724 through analysis of blood samples

    Comparison of AUC

    Time frame: Days 1-2 for preinfusion, 0.5, 1.0, 2.0, 4.0, and 24h; Day 7-8 for prestopping, 0.5, 1.0, 2.0, 4.0, and 24h

  8. Assessment of Steady State Plasma Concentration (Css) of PRI-724 through analysis of blood samples

    Comparison of Css

    Time frame: Days 1-2 for preinfusion, 0.5, 1.0, 2.0, 4.0, and 24h; Day 7-8 for prestopping, 0.5, 1.0, 2.0, 4.0, and 24h

07

Study locations

1 site
  • Tokyo metropolitan Komagome Hospital
    Tokyo, Japan
08

References and documents

Publications

  • Kimura K, Ikoma A, Shibakawa M, Shimoda S, Harada K, Saio M, Imamura J, Osawa Y, Kimura M, Nishikawa K, Okusaka T, Morita S, Inoue K, Kanto T, Todaka K, Nakanishi Y, Kohara M, Mizokami M. Safety, Tolerability, and Preliminary Efficacy of the Anti-Fibrotic Small Molecule PRI-724, a CBP/beta-Catenin Inhibitor, in Patients with Hepatitis C Virus-related Cirrhosis: A Single-Center, Open-Label, Dose Escalation Phase 1 Trial. EBioMedicine. 2017 Sep;23:79-87. doi: 10.1016/j.ebiom.2017.08.016. Epub 2017 Aug 19. PubMed 28844410 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02195440
Lead sponsor
Komagome Hospital
Collaborators
Prism Pharma Co., Ltd., Japan Agency for Medical Research and Development
Responsible party
Kiminori Kimura, MD (MD, Komagome Hospital) — Principal investigator
First posted
Jul 21, 2014
Start date
Aug 2014
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Jul 7, 2022

Study contacts

Kiminori Kimura, MD
principal investigator · Komagome Metropolitan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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