Primary Biliary Cholangitis (PBC)Phase 1NCT04047160
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
A Phase 1 study testing OP-724 in people with Primary Biliary Cholangitis (PBC) and Liver Cirrhosis, Biliary, run by Kiminori Kimura, MD at 2 sites in Japan.
Trial summary
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary
- 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
- 7 participants
- Where
- 2 sitesJapan
- Study dates
- 29 Aug 2019to 31 Mar 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Of the confirmed patients * of primary biliary cholangitis, patients with progressive fibrosis (Scheuer classification stage III or higher) by liver biopsy.
- The diagnosis of primary biliary cholangitis (PBC) is based on the diagnostic criteria (2015) of "Study and research on refractory liver and biliary diseases". That is, one that corresponds to any one of the following is diagnosed as PBC.
- Histologically, chronic non-suppurative destructive cholangitis (CNSDC) is found and the laboratory findings are consistent as PBC.
- A positive antimitochondrial antibody (AMA) with no histologic findings of CNSDC but showing a histology consistent with PBC.
- There is no experience of histologic search, but AMA is positive and it is considered as PBC from clinical image and course.
- (2) Patients with Performance Status 0 to 2.
- (3) Patients aged 20 years or over and under 75 when acquiring informed consent.
- (4) Regarding participation in this trial (including liver biopsy), patients who obtained informed consent by their own voluntary intention.
Who cannot join
- (1) Patients who have liver fibrosis other than primary biliary cholangitis or patients whose cause of liver fibrosis is unknown.
- (2) Patients with esophageal gastric varices determined to be treated by endoscopic examination at screening.
- (3) Patients with complication or previous history of primary liver cancer (excluding those who have had more than one year of hepatocarcinoma resection / radiofrequency ablation).
- (4) 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.
- (5) Patients who can not be denied hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-cell leukemia virus 1 (HTLV-1) or syphilis.
- (6) Serum creatinine value: Patients with more than 1.5 times the upper limit of the facility reference value.
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- (7) Patients with poor control of diabetes, hypertension or heart failure.
- (8) Patients with psychiatric diseases judged to have the potential to influence the implementation of clinical trials.
- (9) Patients who have severe allergy to or contrast media.
- (10) Patients whose dosage regimen was changed within 12 weeks prior to enrollment.
- (11) 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.
- (12) 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.
- (13) Patients who received liver transplantation or other organ transplantation (including bone marrow transplantation) and patients who are difficult to intravenously administer.
- (14) Patients whose liver biopsy is expected to be difficult to perform.
- (15) Patients who are pregnant or nursing, or who are likely to become pregnant.
- (16) 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.
- (17) In addition, patients investigated by investigators or clinical trial doctors as judged unsuitable for this trial.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677
Kyushu University Hospital
Fukuoka, 812-8582
About this study
Official title: An Open-Label, Dose-Finding Study for the CBP / β-catenin Inhibitor OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
Read the detailed description
This trial is a phase I trial aimed at examining the safety and tolerability of OP-724 in patients with primary biliary cholangitis and determining the recommended dose.
The subjects are patients diagnosed with primary biliary cholangitis and diagnosed as progress of fibrosis (Scheuer stage III or higher) as a result of liver tissue examination. As a dosing schedule, OP-724 is intravenously administered twice a week (4 hours) for 12 weeks. However, once 7 days prior to the first cycle of administration, a dose scheduled for the first cycle will be administered once by continuous intravenous administration for 4 hours, and safety and pharmacokinetics will be evaluated on the day of administration to the next day after administration. The dose level shall be 3 doses (140 mg/m2/4hrs, 280 mg/m2/4hrs [starting dose], 380 mg/m2/4hrs), of which 2 doses shall be registered for up to 6 patients each. The safety and pharmacokinetic data after OP-724 administration will be decided comprehensively to determine the recommended dose in the next phase.
- Being tested
- OP-724
- Keywords
- Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary, Cholangitis, Chronic Nonsuppurative Destructive, Liver Cirrhosis, Obstructive, Secondary Biliary Cholangitis, Primary Biliary Cirrhosis, Secondary Biliary Cirrhosis
- Medical subject headings
- Liver Cirrhosis, Biliary
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 group | Role | What they receive |
|---|---|---|
| OP-724 | Experimental | Dose: 140, 280, 380 mg/m2/4 hrs
Administration method:
[Level 1] 140 mg/m2/4 hours [Level 2] 280 mg/m2/4 hours (starting dose) [Level 3] 380 mg/m2/4 hours Continuous intravenous administration will be done for 4 hours twice a week. This procedure will be as one cycle and 12 cycles (12 weeks in total) will be conducted. On 7 days prior to the first cycle administration, a dose scheduled in the first cycle will be administered with continuous intravenous for 4 hours and the safety and pharmacokinetics on the day of administration to the next day after administration will be evaluated. Receives: Drug: OP-724 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence Rate of Serious Adverse Events (Side Effects)
Occurrence Rate of Serious Adverse Events (Side Effects) whose causal relationship with the investigational drug can not be denied. The data will be aggregated by each adverse event and cohort.
Measured: 28 days after the last administration of OP-724
Secondary outcomes (13)
Expression Ratio of Adverse Events
The data will be aggregated by each adverse event and cohort.
Measured: 28 days after the last administration of OP-724
Percentage of Occurrence of Side Effects
The data will be aggregated by each side effect and cohort.
Measured: 28 days after the last administration of OP-724
Drug Concentration (OP-724 and C-82) in Plasma
The data will be aggregated by each cohort.
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 7 days)
Parameters on Pharmacokinetics (OP-724 and C-82) : Maximum Plasma Concentration (Cmax)
The data will be aggregated by each cohort.
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 7 days)
Parameters on Pharmacokinetics (OP-724 and C-82) : Area Under the Curve (AUC 0-24h)
The data will be aggregated by each cohort.
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 7 days)
Liver Tissue Fibrotic Area Ratio by Liver Biopsy
Amount of change from baseline in liver tissue fibrotic area ratio by liver biopsy at 12 weeks after administration. The data will be aggregated by each cohort.
Measured: 12 weeks after administration of OP-724
Liver Stiffness by Fibro Scan
Amount of change from baseline of liver stiffness by Fibro Scan at 12 weeks after administration. The data will be aggregated by each cohort.
Measured: 12 weeks after administration of OP-724
Child-Pugh Score
Amount of change from baseline of 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. The data will be aggregated by each cohort and score.
- Grade A: 5-6 points -> Compensated cirrhosis
- Grade B: 7-9 points -> Decompensated cirrhosis
- Grade C: 10-15 points -> Decompensated cirrhosis
Measured: 12 weeks after administration of OP-724
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 The data will be aggregated by each cohort and score.
Measured: 12 weeks after administration of OP-724
Modified Histological Activity Index (HAI)
Amount of change from baseline of modified Histological Activity Index (HAI) and classification of Nakanuma et al. by liver biopsy at 12 weeks after administration. The data will be aggregated by each cohort and index
Measured: 12 weeks after administration of OP-724
Serum Alkaline Phosphatase (ALP) Level
Amount of change from baseline in serum ALP level at 12 weeks after administration. The data will be aggregated by each cohort and Child-Pugh score.
Measured: 12 weeks after administration of OP-724
Serum Total Bilirubin Value
Amount of change from baseline in serum total bilirubin value at 12 weeks after administration. The data will be aggregated by each cohort and Child-Pugh score.
Measured: 12 weeks after administration of OP-724
Enhanced Liver Fibrosis Panel (ELF) Score
Amount of change from baseline of ELF score at 12 weeks after administration. Observation items: hyaluronic acid, procollagen III peptide, TIMP-1
- ELF score = 2.278 + 0.851 ln (hyaluronic acid) + 0.75 ln (P3 NP) + ln (TIMP). The data will be aggregated by each cohort and score.
Measured: 12 weeks after administration of OP-724
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start29 Aug 2019
- Primary completion21 Sep 2021
- Study completion31 Mar 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 Primary Biliary Cholangitis (PBC)Studies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiminori Kimura, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ohara Pharmaceutical Co., Ltd., Japan Agency for Medical Research and Development
- Responsible party
- Sponsor-investigator, Kiminori Kimura, MD, Komagome Hospital
- Investigators
- Kiminori Kimura, MD, Principal investigator, Tokyo Metropolitan Komagome Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047160
- Sponsor's protocol ID
- OP-724-P101
- Other IDs
- jRCT2031190073
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kimura M, Ogawa E, Harada K, Imamura J, Saio M, Ikura Y, Yatsuhashi H, Murata K, Miura K, Ieiri I, Tanaka A, Kimura K. Feasibility, safety and tolerability of the CREB-binding protein/beta-catenin inhibitor OP-724 in patients with advanced primary biliary cholangitis: an investigator-initiated, open-label, non-randomised, two-centre, phase 1 study. BMJ Open Gastroenterol. 2022 Nov;9(1):e001001. doi: 10.1136/bmjgast-2022-001001.
PubMed 36442892
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Finding Study for the CBP / β-catenin Inhibitor OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
- ClinicalTrials.gov ID
- NCT04047160
- Acronym / sponsor ID
- OP-724-P101
- Keywords
- Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary, Cholangitis, Chronic Nonsuppurative Destructive, Liver Cirrhosis, Obstructive, Secondary Biliary Cholangitis, Primary Biliary Cirrhosis, Secondary Biliary Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Kiminori Kimura, MDUniversity, hospital or other
- Collaborators
- Ohara Pharmaceutical Co., Ltd., Japan Agency for Medical Research and Development
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 6 Aug 2019 (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 pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
Detailed description
This trial is a phase I trial aimed at examining the safety and tolerability of OP-724 in patients with primary biliary cholangitis and determining the recommended dose.
The subjects are patients diagnosed with primary biliary cholangitis and diagnosed as progress of fibrosis (Scheuer stage III or higher) as a result of liver tissue examination. As a dosing schedule, OP-724 is intravenously administered twice a week (4 hours) for 12 weeks. However, once 7 days prior to the first cycle of administration, a dose scheduled for the first cycle will be administered once by continuous intravenous administration for 4 hours, and safety and pharmacokinetics will be evaluated on the day of administration to the next day after administration. The dose level shall be 3 doses (140 mg/m2/4hrs, 280 mg/m2/4hrs [starting dose], 380 mg/m2/4hrs), of which 2 doses shall be registered for up to 6 patients each. The safety and pharmacokinetic data after OP-724 administration will be decided comprehensively to determine the recommended dose in the next phase.
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 | Experimental | Drug: OP-724Dose: 140, 280, 380 mg/m2/4 hrs Administration method: [Level 1] 140 mg/m2/4 hours [Level 2] 280 mg/m2/4 hours (starting dose) [Level 3] 380 mg/m2/4 hours Continuous intravenous administration will be done for 4 hours twice a week. This procedure will be as one cycle and 12 cycles (12 weeks in total) will be conducted. On 7 days prior to the first cycle administration, a dose scheduled in the first cycle will be administered with continuous intravenous for 4 hours and the safety and pharmacokinetics on the day of administration to the next day after administration will be evaluated. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (1) Of the confirmed patients * of primary biliary cholangitis, patients with progressive fibrosis (Scheuer classification stage III or higher) by liver biopsy.
- (2) Patients with Performance Status 0 to 2.
- (3) Patients aged 20 years or over and under 75 when acquiring informed consent.
- (4) Regarding participation in this trial (including liver biopsy), patients who obtained informed consent by their own voluntary intention.
Key exclusion criteria (17 listed)
- (1) Patients who have liver fibrosis other than primary biliary cholangitis or patients whose cause of liver fibrosis is unknown.
- (2) Patients with esophageal gastric varices determined to be treated by endoscopic examination at screening.
- (3) Patients with complication or previous history of primary liver cancer (excluding those who have had more than one year of hepatocarcinoma resection / radiofrequency ablation).
- (4) 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.
- (5) Patients who can not be denied hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-cell leukemia virus 1 (HTLV-1) or syphilis.
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 |
Primary outcome
Occurrence Rate of Serious Adverse Events (Side Effects)
Time frame: 28 days after the last administration of OP-724
Occurrence Rate of Serious Adverse Events (Side Effects) whose causal relationship with the investigational drug can not be denied. The data will be aggregated by each adverse event and cohort.
13 secondary outcomes
Expression Ratio of Adverse Events
Time frame: 28 days after the last administration of OP-724
Percentage of Occurrence of Side Effects
Time frame: 28 days after the last administration of OP-724
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 7 days)
Parameters on Pharmacokinetics (OP-724 and C-82) : Maximum Plasma Concentration (Cmax)
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 7 days)
Parameters on Pharmacokinetics (OP-724 and C-82) : Area Under the Curve (AUC 0-24h)
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 7 days)
Liver Tissue Fibrotic Area Ratio by Liver Biopsy
Time frame: 12 weeks after administration of OP-724
Liver Stiffness by Fibro Scan
Time frame: 12 weeks after administration of OP-724
Child-Pugh Score
Time frame: 12 weeks after administration of OP-724
MELD Score
Time frame: 12 weeks after administration of OP-724
Modified Histological Activity Index (HAI)
Time frame: 12 weeks after administration of OP-724
Serum Alkaline Phosphatase (ALP) Level
Time frame: 12 weeks after administration of OP-724
Serum Total Bilirubin Value
Time frame: 12 weeks after administration of OP-724
Enhanced Liver Fibrosis Panel (ELF) Score
Time frame: 12 weeks after administration of OP-724
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 7 Jul 2022.
- Derived from this study: PubMed 36442892Kimura M, Ogawa E, Harada K, Imamura J, Saio M, Ikura Y, Yatsuhashi H, Murata K, Miura K, Ieiri I, Tanaka A, Kimura K. Feasibility, safety and tolerability of the CREB-binding protein/beta-catenin inhibitor OP-724 in patients with advanced primary biliary cholangitis: an investigator-initiated, open-label, non-randomised, two-centre, phase 1 study. BMJ Open Gastroenterol. 2022 Nov;9(1):e001001. doi: 10.1136/bmjgast-2022-001001.
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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
2 sites 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 Primary Biliary Cholangitis (PBC) and Liver Cirrhosis, Biliary, run by Kiminori Kimura, MD at 2 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 8 inclusion and 17 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Occurrence Rate of 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 NCT04047160, 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 7 Jul 2022.