Hepatic CirrhosisPhase 1NCT00896597
Reproducibility of Child-Turcotte-Pugh (CTP) Rating and NRL972 Pharmacokinetics in Patients With Cirrhosis
A Phase 1 study testing NRL972 in people with Hepatic Cirrhosis, run by Norgine at 1 site in Romania.
Trial summary
This is an open, randomized study in patients with different severity stages of hepatic cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32 to 40 pairs of raters. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Cirrhosis
- What is being tested?
- NRL972
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2009to Dec 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give written Informed Consent.
- Gender: male and female (non-childbearing potential = postmenopausal or medically adequate contraception).
- Ethnicity: Any.
- Age: 18 to 80 years of age.
- Patient volunteers with a diagnosis of clinically stable hepatic cirrhosis with a CTP class A, B and C but excluding patient volunteers with the diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis and cystic fibrosis-associated liver disease.
- No previous liver transplantation or intended liver transplantation within the next 6 months after enrollment.
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- No previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA).
- Medically fit to undergo the protocol-defined procedures without undue risk and discomfort.
- No previous participation in a study with an investigational product within 90 days prior to enrolment except epidemiologic or observational studies.
Who cannot join
- Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial test or rescreening).
- Donation of blood during the last 60 days or a history of excessive blood loss within the last 3 months, assessed using clinical judgement.
- Any donation of germ cells, blood, organs or bone marrow during the course of the study.
- History of any clinically relevant allergy (including hypersensitivity to the IMP).
- Presence of clinical relevant acute or chronic infection (other than chronic viral hepatitis, if applicable).
- Presence of hepatic encephalopathy at grades 3 or 4
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- Unstable clinical presentation of hepatic cirrhosis (not allowing completion of participation in the study within 6 weeks).
- Use of confounding concomitant medication (see Section 7.5.7).
- Presence or history of any end-stage (co-)morbidity (excluding the effects of hepatic cirrhosis) such as: malignancy and clinically relevant systemic diseases.
- Presence of primary and/or hepatic malignancy.
- Suspicion or evidence that the patient volunteer is not trustworthy and reliable.
- Suspicion or evidence that the patient volunteer is not able to make a free consent or to understand the information in this regard.
- Primary biliary cirrhosis and primary sclerosing cholangitis.
- Cystic fibrosis.
- Patient volunteers who are employees at the investigational site, relatives or spouses of the investigator.
- Current drug or medication abuse.
- Special restrictions for female patient volunteers:
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career or lifestyle precludes intercourse with a male partner and women whose partners have been sterilised by vasectomy or other means, unless they meet the following definition of post-menopausal:
- 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy
- OR are using one or more of the following acceptable methods of contraception:
- surgical sterilisation (e.g., bilateral tubal ligation, vasectomy)
- hormonal contraception (implantable, patch, oral), and
- double-barrier methods (any double combination of: an intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomised Study to Compare the Reproducibility of CTP Rating and NRL972 Pharmacokinetics in Patient Volunteers With Hepatic Cirrhosis.
This is an open, randomized study in patients with different severity stages of hepatic cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32 to 40 pairs of raters. The raters will perform the required assessments in the capacity of sub-investigators of the phase I (co-ordinating) unit.
Up to 240 patients with clinically established hepatic cirrhosis without confounding end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of eligibility, Visit 1 will take place to determine the investigational parameters (NRL972 pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational parameters will again be assessed.
- Conditions
- Hepatic Cirrhosis
- Being tested
- NRL972
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL972Drug
2 mg NRL972 in 5 mL solution for injection administered as a 15-second intravenous injection on each of four occasions.
| Study group | Role | What they receive |
|---|---|---|
| NRL972 | Experimental | A single dose of 2 mg NRL972 will be administered on four occasions over a period of up to 6 weeks. Receives: Drug: NRL972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the reproducibility of the CTP sum score with the reproducibility of the pharmacokinetics of NRL972, both assessed by a rater pair, in patients with stable hepatic cirrhosis.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Jürgen Gruss, MD, Study director, Norgine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896597
- Sponsor's protocol ID
- NRL972-11/2008 (PAIR)
- Status last verified
- Aug 2010
- First submitted
- 8 May 2009
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised Study to Compare the Reproducibility of CTP Rating and NRL972 Pharmacokinetics in Patient Volunteers With Hepatic Cirrhosis.
- ClinicalTrials.gov ID
- NCT00896597
- Acronym / sponsor ID
- NRL972-11/2008 (PAIR)
- Conditions
- Hepatic Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 11 May 2009 (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.
This is an open, randomized study in patients with different severity stages of hepatic cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32 to 40 pairs of raters. The raters will perform the required assessments in the capacity of sub-investigators of the phase I (co-ordinating) unit.
Up to 240 patients with clinically established hepatic cirrhosis without confounding end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of eligibility, Visit 1 will take place to determine the investigational parameters (NRL972 pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational parameters will again be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRL972 | Experimental | Drug: NRL972A single dose of 2 mg NRL972 will be administered on four occasions over a period of up to 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to give written Informed Consent.
- Gender: male and female (non-childbearing potential = postmenopausal or medically adequate contraception).
- Ethnicity: Any.
- Age: 18 to 80 years of age.
- Patient volunteers with a diagnosis of clinically stable hepatic cirrhosis with a CTP class A, B and C but excluding patient volunteers with the diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis and cystic fibrosis-associated liver disease.
Key exclusion criteria (24 listed)
- Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial test or rescreening).
- Donation of blood during the last 60 days or a history of excessive blood loss within the last 3 months, assessed using clinical judgement.
- Any donation of germ cells, blood, organs or bone marrow during the course of the study.
- History of any clinically relevant allergy (including hypersensitivity to the IMP).
- Presence of clinical relevant acute or chronic infection (other than chronic viral hepatitis, if applicable).
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 |
|---|---|---|
| NRL9722 mg NRL972 in 5 mL solution for injection administered as a 15-second intravenous injection on each of four occasions. | Drug | NRL972 |
Primary outcome
Comparison of the reproducibility of the CTP sum score with the reproducibility of the pharmacokinetics of NRL972, both assessed by a rater pair, in patients with stable hepatic cirrhosis.
Time frame: Up to 6 weeks
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 9 Aug 2010.
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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.
Hans-Jürgen Gruss, MD study director
Norgine
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 NRL972 in people with Hepatic Cirrhosis, run by Norgine at 1 site in Romania.
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 9 inclusion and 24 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 9 Aug 2010. 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 Romania. 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?
Comparison of the reproducibility of the CTP sum score with the reproducibility of the pharmacokinetics of NRL972, both assessed by a rater pair, in patients with stable hepatic cirrhosis. (time frame: Up to 6 weeks). 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 9 Aug 2010.