Hepatic CirrhosisPhase 1NCT00856713
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
A Phase 1 study testing NRL972 in people with Hepatic Cirrhosis, run by Norgine at 1 site in Bulgaria.
Trial summary
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972) Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- 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
- 72 participants
- Where
- 1 siteBulgaria
- Study dates
- Mar 2006to Aug 2006
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting the following conditions will be eligible for enrolment:
- General - all subjects
- Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Caucasian
- BMI: between 19 and 34 kg.m-2
- BW: between 45 and 110 kg
Show all 13Show fewer
- willing and able to provide informed consent
- Healthy volunteers (group N)
- Age: 18 - 40 years (inclusive) and > 60 years
- Assessed as healthy based on the pre-study examination
- Hepatic cirrhosis
- Age: 18 - 75 years
- stable compensated liver cirrhosis (cryptogenic, posthepatic, alcoholic) with histo-logical or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation
Who cannot join
- Subjects of any of the following categories will be excluded from enrolment:
- General - all subjects
- Previous participation in the trial
- Participant in any other trial during the last 90 days
- Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- History of any clinically relevant allergy
Show all 30Show fewer
- Presence of acute or chronic infection
- Uncontrolled diabetes mellitus
- Resting systolic blood pressure > 160 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
- Positive HIV test
- Positive alcohol or urine drug test on recruitment
- Daily use of > 30 gr alcohol
- Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- Use of prohibited medication
- Suspicion or evidence that the subject is not trustworthy and reliable
- Suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard
- General - all females
- Positive pregnancy test
- Lactating
- Not using appropriate contraception in premenopausal women
- All healthy subjects
- Presence or history of any relevant comorbidity
- Presence of any relevant abnormality in the laboratory safety tests, especially low Hemoglobin, increased liver enzymes, reduced serum creatinine
- Positive serology for HBsAg, anti HBc and anti HCV
- History of alcohol and/or drug abuse
- Patients with hepatic disease
- Biliary liver cirrhosis
- Liver impairment due to space-occupying processes (e.g. carcinoma)
- State after liver transplantation or patient scheduled for liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study in Healthy Volunteers and Patients With Liver Cirrhosis to Assess the Effects of Age, Gender, and Stable Liver Disease on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) as an in-Vivo Marker of Liver Function in Man
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
- 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
Single intravenous dose of 2 mg NRL972
NRL972Drug
Single intravenous dose of 2 mg NRL972
NRL972Drug
Single intravenous dose of 2 mg NRL972
NRL972Drug
Single intravenous dose of 2 mg NRL972
NRL972Drug
Single intravenous dose of 2 mg NRL972
NRL972Drug
Single intravenous dose of 2 mg NRL972
| Study group | Role | What they receive |
|---|---|---|
| 1 YM | Experimental | Healthy young males Receives: Drug: NRL972 |
| 2 EM | Experimental | Healthy elderly males Receives: Drug: NRL972 |
| 3 YF | Experimental | Healthy young females Receives: Drug: NRL972 |
| 4 EF | Experimental | Healthy elderly females Receives: Drug: NRL972 |
| 5 CTP-A | Experimental | Patients with hepatic cirrhosis CTP-class A Receives: Drug: NRL972 |
| 6 CTP-BC | Experimental | Patients with hepatic cirrhosis CTP-class B and C Receives: Drug: NRL972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis
Measured: Up to 4 hrs post administration of NRL972
Secondary outcomes (4)
Adverse events and changes in physical findings from baseline
Measured: Up to 4 hours post-dosing
Effects on vital signs: blood pressure, pulse rate
Measured: Up to 4 hours post-dosing
Effects on electrocardiogram
Measured: Up to 4 hours post-dosing
Changes in haematology, clinical chemistry, urinalysis
Measured: Up to 4 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2006
- Primary completionAug 2006
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Jürgen Gruss, MD, Study director, NorgineZahariy Krastev, MD, Principal investigator, St Ivan Rilski's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856713
- Sponsor's protocol ID
- NRL972-01/2005 (ACPS)
- Status last verified
- Mar 2009
- First submitted
- 4 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Volunteers and Patients With Liver Cirrhosis to Assess the Effects of Age, Gender, and Stable Liver Disease on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) as an in-Vivo Marker of Liver Function in Man
- ClinicalTrials.gov ID
- NCT00856713
- Acronym / sponsor ID
- NRL972-01/2005 (ACPS)
- Conditions
- Hepatic Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2006 (actual)
- First posted
- 6 Mar 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.
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 YM | Experimental | Drug: NRL972Healthy young males |
| 2 EM | Experimental | Drug: NRL972Healthy elderly males |
| 3 YF | Experimental | Drug: NRL972Healthy young females |
| 4 EF | Experimental | Drug: NRL972Healthy elderly females |
| 5 CTP-A | Experimental | Drug: NRL972Patients with hepatic cirrhosis CTP-class A |
| 6 CTP-BC | Experimental | Drug: NRL972Patients with hepatic cirrhosis CTP-class B and C |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- General - all subjects
- Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Caucasian
- BMI: between 19 and 34 kg.m-2
- BW: between 45 and 110 kg
Key exclusion criteria (30 listed)
- General - all subjects
- Previous participation in the trial
- Participant in any other trial during the last 90 days
- Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- History of any clinically relevant allergy
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 |
|---|---|---|
| NRL972Single intravenous dose of 2 mg NRL972 | Drug | 1 YM |
| NRL972Single intravenous dose of 2 mg NRL972 | Drug | 2 EM |
| NRL972Single intravenous dose of 2 mg NRL972 | Drug | 3 YF |
| NRL972Single intravenous dose of 2 mg NRL972 | Drug | 4 EF |
| NRL972Single intravenous dose of 2 mg NRL972 | Drug | 5 CTP-A |
| NRL972Single intravenous dose of 2 mg NRL972 | Drug | 6 CTP-BC |
Primary outcome
Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis
Time frame: Up to 4 hrs post administration of NRL972
4 secondary outcomes
Adverse events and changes in physical findings from baseline
Time frame: Up to 4 hours post-dosing
Effects on vital signs: blood pressure, pulse rate
Time frame: Up to 4 hours post-dosing
Effects on electrocardiogram
Time frame: Up to 4 hours post-dosing
Changes in haematology, clinical chemistry, urinalysis
Time frame: Up to 4 hours post-dosing
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 6 Mar 2009.
Related trials for Hepatic Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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
Zahariy Krastev, MD principal investigator
St Ivan Rilski's University Hospital
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 Bulgaria.
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 30 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 6 Mar 2009. 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 Bulgaria. 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?
Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis (time frame: Up to 4 hrs post administration of NRL972). 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 6 Mar 2009.