Hepatic ImpairmentPhase 1NCT00432627
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
A Phase 1 study testing Deferasirox in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Deferasirox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Aug 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical signs consistent with a clinical diagnosis of liver cirrhosis
- Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
- Otherwise considered healthy
- In good health.
Who cannot join
- Clinically significant abnormal findings other than hepatic impairment
- Clinical evidence of severe ascites
- History of surgical portosystemic shunt
- Any evidence of progressive liver disease within the last 4 weeks
- Clinical evidence of liver disease or liver injury
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- Use of any prescription medication within 1 month prior to dosing
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
- Conditions
- Hepatic Impairment
- Being tested
- Deferasirox
- Keywords
- Hepatic impairment, adults, deferasirox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferasiroxDrug
Also called ICL670
one dose of 20 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impaired | Experimental | Not described Receives: Drug: Deferasirox |
| Moderate hepatic impaired | Experimental | Not described Receives: Drug: Deferasirox |
| Severe hepatic impaired | Experimental | Not described Receives: Drug: Deferasirox |
| Healthy volunteers | Experimental | Controlled group Receives: Drug: Deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of deferasirox and its metabolites
Measured: at FPFV and at LPLV
Secondary outcomes (1)
Safety and tolerability of deferasirox assessed by adverse events
Measured: at FPFV and at LPLV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432627
- Sponsor's protocol ID
- CICL670A2125
- Status last verified
- Apr 2016
- First submitted
- 7 Feb 2007
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT00432627
- Acronym / sponsor ID
- CICL670A2125
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment, adults, deferasirox
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Feb 2007 (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 study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impaired | Experimental | Drug: Deferasirox |
| Moderate hepatic impaired | Experimental | Drug: Deferasirox |
| Severe hepatic impaired | Experimental | Drug: Deferasirox |
| Healthy volunteers | Experimental | Drug: DeferasiroxControlled group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical signs consistent with a clinical diagnosis of liver cirrhosis
- Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
- Otherwise considered healthy
- In good health.
Key exclusion criteria (8 listed)
- Clinically significant abnormal findings other than hepatic impairment
- Clinical evidence of severe ascites
- History of surgical portosystemic shunt
- Any evidence of progressive liver disease within the last 4 weeks
- Clinical evidence of liver disease or liver injury
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 |
|---|---|---|
| DeferasiroxAlso: ICL670one dose of 20 mg/kg/day | Drug | Healthy volunteers, Mild hepatic impaired, Moderate hepatic impaired, Severe hepatic impaired |
Primary outcome
Pharmacokinetics of deferasirox and its metabolites
Time frame: at FPFV and at LPLV
1 secondary outcome
Safety and tolerability of deferasirox assessed by adverse events
Time frame: at FPFV and at LPLV
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 Dec 2020.
- Results can be found for CICL670A2125 on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
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 Deferasirox in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 1 site in Germany.
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 4 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 9 Dec 2020. 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 Germany. 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?
Pharmacokinetics of deferasirox and its metabolites (time frame: at FPFV and at LPLV). 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 Dec 2020.