Hepatitis, Viral, HumanPhase 2NCT00915057
Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.
A Phase 2 study testing NRL972 in people with Hepatitis, Viral, Human, run by Norgine at 4 sites in 2 countries.
Trial summary
Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis, Viral, Human
- 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
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2009to Mar 2009
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic viral hepatitis B
- Adult, male or female, age ≥ 18 years and < 65 years
- Body weight (BW) : 45 - 110 kg
- Body mass index (BMI) : 18 - 30 kg.m-2
- HBV Serology: HBsAg+ for ≥ 6 months (at the time of application for treatment)
- Serum ALT ≥ 1.5 times ULN ≥ 6 months (at the time of application for treatment)
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- Positive liver biopsy within 24 months before screening visit
- Positive biopsy with signs of active disease (any level of activity by Knodell, METAVIR or ISHAK)
- HBV DNA counts determined by quantitative PCR: ≥ 20,000 IU/mL ALT < 10 times ULN
- HIV-Ab negative
- Non-cirrhotic liver disease (on histology within 24 months before screening visit)
- Not having been treated for chronic viral hepatitis previously ("de novo" i.e. "naïve")
- Eligible for treatment of chronic viral hepatitis in accordance with the national consensus guidelines pertinent to the country and site of conduct of the trial
- Willing and able to provide informed consent
- Chronic viral hepatitis C
- Adult, male or female, age ≥ 18 years and < 65 years
- Body weight (BW) : 45 - 110 kg
- Body mass index (BMI) : 18 - 30 kg.m-2
- HCV-Ab+ for ≥ 6 months (at the time of application for treatment)
- HCV RNA counts > 10,000 U/L by quantitative PCR assay within the last 6 months (at the time of application for treatment)
- Positive liver biopsy within 24 months before application for treatment
- Positive biopsy with signs of fibrotic disease (levels of fibrosis METAVIR ≥ F1 or ISHAK ≥ F2)
- ALT < 10 times ULN
- HIV-Ab negative
- Non-cirrhotic liver disease (on histology within 24 months before screening visit)
- Not having been treated for chronic viral hepatitis previously ("de novo" i.e. "naïve")
- Eligible for treatment of chronic viral hepatitis in accordance with the national consensus guidelines pertinent to the country and site of conduct of the trial
- Willing and able to provide informed consent
- Chronic viral hepatitis C plus chronic viral hepatitis B
- Patients with combined CHB and CHC will be managed (in terms of eligibility and standard treatment in accordance with the hepatitis type with predominant viral replication.
Who cannot join
- Trial specific criteria: CHB, CHC \& CHB+CHC
- Previous participation in the trial
- Participation in any other clinical trial within 30 days of entry to this protocol
- Treatment with any investigational drug within 30 days of entry to this protocol
- Non-response to previous treatment for chronic viral hepatitis
- Relapse after previous treatment for chronic viral hepatitis
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- Any other known cause of liver disease other than chronic viral hepatitis B and/or C, including but not limited to hepatitis D, haemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, drug-related liver disease
- Evidence of advanced liver disease, such as history or presence of ascites, bleeding varices, encephalopathy
- Patients with organ transplants
- Hypersensitivity to prospective standard treatment
- Any relevant co-morbidity, for instance, but not limited to:
- Limiting uncompensated psychiatric condition (e.g. severe depression, or a history of severe psychiatric disorder)
- CNS trauma or seizure disorder requiring medication
- Significant cardiovascular dysfunction within the past 6 months (e.g. angina, congestive cardiac failure, recent myocardial infarction, severe hypertension or significant arrhythmia)
- Patients with an ECG showing clinically significant abnormalities
- Poorly controlled diabetes mellitus
- Patients on haemodialysis
- Daily use of > 40 g alcohol
- Positive alcohol test at SCR-visit
- Evidence or suspicion of social drug abuse
- Positive drug test at SCR-visit
- 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
- Criteria specifically related to the standard treatment of chronic viral hepatitis
- Relevant clinical laboratory test abnormalities, for instance, but not limited to:
- Haemoglobin (Hgb) <11 g dL-1 for women and <13 g dL-1 for men
- White Blood Cell count (WBC) < 3,000 10 exp9/mL
- Granulocyte count < 1,500 10 exp9/mL
- Lymphocyte count < 500 10 exp9/mL
- Platelets < 75,000 10 exp9/mL
- Prothrombin time - INR > 1.4
- Bilirubin > 25 micromol/L (except in functional hyperbilirubinaemia)
- Albumin < 35 g/L
- Serum creatinine > 133 micromol/L
- Fasting blood glucose > 7.4 mmol/L for non-diabetic patients
- HbA1c > 7% for diabetic patients
- Positive auto-immune antibodies
- TSH outside the normal range (for patients intended for interferon)
- Relevant co-morbidity, for instance, but not limited to:
- Limiting uncompensated chronic pulmonary disease (e.g. chronic obstructive pulmonary disease)
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids
- Gout - (for patients intended for interferon)
- Immunologically mediated disease (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, cryoglobulinaemia with vasculitis) - (for patients intended for interferon)
- Patients with clinically significant retinal abnormalities - (for patients intended for interferon)
- All females
- Positive pregnancy test
- Lactating
- Not using medically appropriate contraception and/or not willing to maintain such contraception during the treatment of chronic viral hepatitis and up to 6 months thereafter
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Romania3 sites
Clinical Institute Fundeni
Bucharest
Emergency Country Hospital Cluj
Cluj-Napoca
Private Clinic Algomed SRL
Timișoara
About this study
Official title: An Open Study to Investigate the Effects of Chronic Viral Hepatitis B or C on the Pharmacokinetics of Cholyl-lysyl-fluorescein (NRL972) Before, During and After Standard Treatment.
Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. This study aims to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC) who are eligible for treatment in accordance with the established consensus guidelines in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline (within one month of starting treatment), at 3-monthly intervals during treatment, for up to 12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment. This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972 in detecting changes in biliary clearance during and after treatment for CHB and CHC.
- Conditions
- Hepatitis, Viral, Human
- Being tested
- NRL972
- Medical subject headings
- Hepatitis, Viral, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL972Drug
Single dose of NRL972 administered at baseline, at 3-monthly intervals during treatment for up to 12 months (or the end of treatment) and at 3 and 6 months after the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| NRL972 | Experimental | Single 2mg intravenous dose of NRL972, administered on up to seven occasions Receives: Drug: NRL972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of NRL972
Measured: Up to one hour post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, Viral, HumanStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT00915057
- Sponsor's protocol ID
- NRL972-09/2008 (CHBC)
- Status last verified
- Dec 2009
- First submitted
- 3 Jun 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Investigate the Effects of Chronic Viral Hepatitis B or C on the Pharmacokinetics of Cholyl-lysyl-fluorescein (NRL972) Before, During and After Standard Treatment.
- ClinicalTrials.gov ID
- NCT00915057
- Acronym / sponsor ID
- NRL972-09/2008 (CHBC)
- Conditions
- Hepatitis, Viral, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Jun 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.
Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. This study aims to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC) who are eligible for treatment in accordance with the established consensus guidelines in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline (within one month of starting treatment), at 3-monthly intervals during treatment, for up to 12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment. This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972 in detecting changes in biliary clearance during and after treatment for CHB and CHC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRL972 | Experimental | Drug: NRL972Single 2mg intravenous dose of NRL972, administered on up to seven occasions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Chronic viral hepatitis B
- Adult, male or female, age ≥ 18 years and < 65 years
- Body weight (BW) : 45 - 110 kg
- Body mass index (BMI) : 18 - 30 kg.m-2
- HBV Serology: HBsAg+ for ≥ 6 months (at the time of application for treatment)
Key exclusion criteria (49 listed)
- Trial specific criteria: CHB, CHC \& CHB+CHC
- Previous participation in the trial
- Participation in any other clinical trial within 30 days of entry to this protocol
- Treatment with any investigational drug within 30 days of entry to this protocol
- Non-response to previous treatment for chronic viral hepatitis
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 dose of NRL972 administered at baseline, at 3-monthly intervals during treatment for up to 12 months (or the end of treatment) and at 3 and 6 months after the end of treatment. | Drug | NRL972 |
Primary outcome
Pharmacokinetics of NRL972
Time frame: Up to one hour 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 23 Dec 2009.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRL972 in people with Hepatitis, Viral, Human, run by Norgine at 4 sites in 2 countries.
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 30 inclusion and 49 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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Romania, 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 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?
Pharmacokinetics of NRL972 (time frame: Up to one hour post-dosing). 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 23 Dec 2009.