Hepatic CirrhosisPhase 1/2NCT00856869
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
A Phase 1/2 study testing NRL972 in people with Hepatic Cirrhosis and Nonalcoholic Steatohepatitis, run by Norgine at 1 site in Bulgaria.
Trial summary
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and elderly healthy females, to assess the effects of… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
- 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
- 52 participants
- Where
- 1 siteBulgaria
- Study dates
- Aug 2004to Apr 2005
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General - all subjects
- Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- Caucasian
- BMI: between 19 and 34 kg.m-2
- BW: between 45 and 110 kg
- willing and able to provide informed consent Healthy volunteers (group N)
Show all 12Show fewer
- Age: 18 - 40 years (inclusive) e.g. > 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 Nonalcoholic steatohepatitis (NASH)
- Age: 18 - 75 years
- Diagnosis of NASH confirmed by liver biopsy
Who cannot join
- 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 450 mL within the last 3 months
- History of any clinically relevant allergy
- Uncontrolled diabetes mellitus or any further intolerability of the Galactose test
Show all 37Show fewer
- Presence of acute or chronic infection
- 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
- Clinically relevant ECG-abnormalities that constitute a contraindication for the Lido-cain-MEG'-X-test
- 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 (list of past and present diseases will be reviewed by an expert panel)
- Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes, reduced serum creatinine (laboratory test abnormalities will be reviewed by an expert panel)
- 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
- Fluctuating or rapidly deteriorating hepatic function
- Significant bleeding diathesis
- Oesophageal bleeding within the last 8 weeks before study entry
- Ascites > 6 L on abdominal US
- Number Connection test: time to connect 25 consecutive numbers > 30 sec
- Presence or history of any relevant comorbidity other than hepatic disease (list of past and present diseases will be reviewed by an expert panel)
- Clinically relevant abnormal laboratory values other than those associated or sufficiently explained by the existing liver disease (laboratory test abnormalities will be reviewed by an expert panel)
- History of drug or alcohol abuse within 2 months prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study in Healthy Volunteers and Patients With Liver Cirrhosis and Non-Alcoholic Steatohepatitis (NASH) to Assess the Effects of Age, Gender, Chronic Liver Disease, and Prandial Effects on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) an an in-Vivo Marker of Liver Function in Man.
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide information on the safety and tolerability of repeated intravenous doses of NRL972 in these populations.
- Conditions
- Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
- Being tested
- NRL972
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
NRL972Drug
Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
| 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 NASH | Experimental | Patients with presumed NASH Receives: Drug: NRL972 |
| 6 CTP-A | Experimental | Patients with hepatic cirrhosis CTP-class A Receives: Drug: NRL972 |
| 7 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 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.
Measured: Up to 4 hours post administration of NRL972
Secondary outcomes (4)
Adverse events and changes in physical findings from baseline
Measured: Up to 4 hours post-dosing
Effects of 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 startAug 2004
- Primary completionFeb 2005
- Study completionApr 2005
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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zahariy Krastev, MD, Principal investigator, St. Ivan Rilski's University HospitalHans-Jürgen Gruss, MD, Study director, Norgine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856869
- Sponsor's protocol ID
- NRL972-02/2003(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 and Non-Alcoholic Steatohepatitis (NASH) to Assess the Effects of Age, Gender, Chronic Liver Disease, and Prandial Effects on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) an an in-Vivo Marker of Liver Function in Man.
- ClinicalTrials.gov ID
- NCT00856869
- Acronym / sponsor ID
- NRL972-02/2003(ACPS)
- Conditions
- Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Apr 2005 (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.
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide information on the safety and tolerability of repeated intravenous doses of NRL972 in these populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| 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 NASH | Experimental | Drug: NRL972Patients with presumed NASH |
| 6 CTP-A | Experimental | Drug: NRL972Patients with hepatic cirrhosis CTP-class A |
| 7 CTP-BC | Experimental | Drug: NRL972Patients with hepatic cirrhosis CTP-class B and C |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General - all subjects
- Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- Caucasian
- BMI: between 19 and 34 kg.m-2
- BW: between 45 and 110 kg
Key exclusion criteria (37 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 450 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 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 1 YM |
| NRL972Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 2 EM |
| NRL972Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 3 YF |
| NRL972Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 4 EF |
| NRL972Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 5 NASH |
| NRL972Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 6 CTP-A |
| NRL972Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal | Drug | 7 CTP-BC |
Primary outcome
Clearance of NRL972 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.
Time frame: Up to 4 hours 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 of 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.
Zahariy Krastev, MD principal investigator
St. Ivan Rilski's University Hospital
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 1/2 study testing NRL972 in people with Hepatic Cirrhosis and Nonalcoholic Steatohepatitis, 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 12 inclusion and 37 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis. (time frame: Up to 4 hours 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.