Hepatitis C Virus-infected CirrhosisNCT02828254
A Follow-up Evaluation Study of PRI-724-1101
An observational study of Hepatitis C Virus-infected Cirrhosis, run by Komagome Hospital at 1 site in Japan.
Trial summary
The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatitis C Virus-infected Cirrhosis
- What is being tested?
- PRI-724
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 18 Dec 2014to 31 Jan 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PRI-724 administration in patients with cirrhosis due to hepatitis C
Who may be able to join
- Having been administered PRI-724 in Study 1101 after being confirmed to meet the inclusion criteria and not to meet the exclusion criteria and consenting to participate in the study.
- Having provided voluntary written consent for participation in this study.
Who cannot join
- Patients who are pregnant or may be pregnant, or who desire to become pregnant or may be pregnant during the clinical study [excluding patients who have undergone a sterilization procedure or postmenopausal patients (if amenorrhea without medical reasons continues more than 12 months), patients who are nursing.
- Patients who do not consent to practice birth control during the clinical study (including male patients).
- Patients with serious allergy to contrast media or a history thereof.
- 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.
- Patients contraindicated for liver biopsy. However, this criterion will not apply to a patient who has turned out to be contraindicated for liver biopsy after having been administered PRI-724 in Study 1101.
- Patients who participated in another clinical trial, except PRI-724-1101 trial, within 30 days at the time of providing written consent.
- Patients who have discontinued administration of PRI-724 in Study 1101 due to death or other reasons and become lost for follow-up.
- Other, at the point when Study 1101 has been completed (or discontinued), patients who are judged inappropriate for inclusion in the study by the investigator for such reasons as the presence of serious pathological condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Follow-up Evaluation Study of the Safety and Efficacy of PRI-724 Administration in Patients With Cirrhosis Due to Hepatitis C
The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.
Read the detailed description
This is a single-center, nonintervention, open-label, observational study in subjects who received the study drug (identification code: PRI-724) in Study 1101 to follow up the safety and disease condition of cirrhosis after administration for 12 months.
In Study 1101, one cycle consisted of 2 weeks with one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. Treatment with a total of six cycles (duration of treatment, 12 weeks) was performed.
In this study, the subjects in each cohort in Study 1101 (PRI-724 dose: Cohort 1, 10 mg/m2/day; Cohort 2, 40 mg/m2/day; Cohort 3, 160 mg/m2/day) were followed up and observed for 12 months after administration.
In Study 1101, target number of subjects was 6 subjects in each cohort, a total of 18 subjects. However, the number of registered subjects was 7 subjects in Cohort 1, 7 subjects in Cohort 2, and 2 subjects in Cohort 3, a total of 16 subjects. Safety analysis set was 6 subjects, 6 subjects, and 2 subjects, respectively, a total of 14 subjects. Target number of the subjects in this study was the same as that in Study 1101; however, of the subjects in Study 1101, 5 subjects in Cohort 1 and 3 subjects in Cohort 2 consented to participate in this study (Study 1102).
- Conditions
- Hepatitis C Virus-infected Cirrhosis
- Being tested
- PRI-724
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRI-724Drug
Also called CBP-beta-catennin inhibitor, OP-724
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidences of adverse events and adverse drug reactions
The data will be aggregated by each adverse events, cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Secondary outcomes (7)
Incidence of liver cancer
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Child-Pugh Score
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Liver biopsy (Only in applicable patients)
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Serum albumin level
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Serum fibrosis marker level(s)
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Ascitic fluid level
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Improvement rate of lower leg edema
The data will be aggregated by each cohort and Child-Pugh score
Measured: 12 months after completion of the clinical trial, PRI-724-1101
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start18 Dec 2014
- Primary completion27 Mar 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus-infected 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Komagome Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Prism Pharma Co., Ltd., Japan Agency for Medical Research and Development
- Responsible party
- Principal investigator, Kiminori Kimura, MD, Komagome Hospital
- Investigators
- Kiminori Kimura, MD, Principal investigator, Komagome Metropolitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828254
- Sponsor's protocol ID
- PRI-724-1102
- Other IDs
- UMIN000014891
- Status last verified
- Jul 2022
- First submitted
- 15 Jun 2016
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Follow-up Evaluation Study of the Safety and Efficacy of PRI-724 Administration in Patients With Cirrhosis Due to Hepatitis C
- ClinicalTrials.gov ID
- NCT02828254
- Acronym / sponsor ID
- PRI-724-1102
- Conditions
- Hepatitis C Virus-infected Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Komagome HospitalUniversity, hospital or other
- Collaborators
- Prism Pharma Co., Ltd., Japan Agency for Medical Research and Development
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.
Detailed description
This is a single-center, nonintervention, open-label, observational study in subjects who received the study drug (identification code: PRI-724) in Study 1101 to follow up the safety and disease condition of cirrhosis after administration for 12 months.
In Study 1101, one cycle consisted of 2 weeks with one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. Treatment with a total of six cycles (duration of treatment, 12 weeks) was performed.
In this study, the subjects in each cohort in Study 1101 (PRI-724 dose: Cohort 1, 10 mg/m2/day; Cohort 2, 40 mg/m2/day; Cohort 3, 160 mg/m2/day) were followed up and observed for 12 months after administration.
In Study 1101, target number of subjects was 6 subjects in each cohort, a total of 18 subjects. However, the number of registered subjects was 7 subjects in Cohort 1, 7 subjects in Cohort 2, and 2 subjects in Cohort 3, a total of 16 subjects. Safety analysis set was 6 subjects, 6 subjects, and 2 subjects, respectively, a total of 14 subjects. Target number of the subjects in this study was the same as that in Study 1101; however, of the subjects in Study 1101, 5 subjects in Cohort 1 and 3 subjects in Cohort 2 consented to participate in this study (Study 1102).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PRI-724 administration in patients with cirrhosis due to hepatitis C
Key inclusion criteria (2 listed)
- Having been administered PRI-724 in Study 1101 after being confirmed to meet the inclusion criteria and not to meet the exclusion criteria and consenting to participate in the study.
- Having provided voluntary written consent for participation in this study.
Key exclusion criteria (8 listed)
- Patients who are pregnant or may be pregnant, or who desire to become pregnant or may be pregnant during the clinical study [excluding patients who have undergone a sterilization procedure or postmenopausal patients (if amenorrhea without medical reasons continues more than 12 months), patients who are nursing.
- Patients who do not consent to practice birth control during the clinical study (including male patients).
- Patients with serious allergy to contrast media or a history thereof.
- 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.
- Patients contraindicated for liver biopsy. However, this criterion will not apply to a patient who has turned out to be contraindicated for liver biopsy after having been administered PRI-724 in Study 1101.
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 |
|---|---|---|
| PRI-724Also: CBP-beta-catennin inhibitor, OP-724 | Drug | – |
Primary outcome
Safety: Incidences of adverse events and adverse drug reactions
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
The data will be aggregated by each adverse events, cohort and Child-Pugh score
7 secondary outcomes
Incidence of liver cancer
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
Child-Pugh Score
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
Liver biopsy (Only in applicable patients)
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
Serum albumin level
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
Serum fibrosis marker level(s)
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
Ascitic fluid level
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
Improvement rate of lower leg edema
Time frame: 12 months after completion of the clinical trial, PRI-724-1101
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.
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
Komagome Metropolitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus-infected Cirrhosis, run by Komagome Hospital 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 2 inclusion and 8 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 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.
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?
Safety: Incidences of adverse events and adverse drug reactions (time frame: 12 months after completion of the clinical trial, PRI-724-1101). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.