Hepatic CirrhosisPhase 1NCT00698464
Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
A Phase 1 study testing Pasireotide in people with Hepatic Cirrhosis and Alcoholism, run by Novartis Pharmaceuticals at 4 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cirrhosis, Alcoholism
- What is being tested?
- Pasireotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2008to Apr 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common Inclusion criteria for all subjects:
- Male or female subjects between 18 and 75 years of age, inclusive.
- Vital signs at screening and baseline which are within normal ranges.
- Subjects must have a BMI between 20 kg/m2 and 30 kg/m2.
- Generally healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram and standard laboratory tests at screening.
- Subjects with confirmed cirrhosis by at least one of the following criteria:
- Histologically by prior liver biopsy showing cirrhosis.
- Clinically by physical examination, and/or laboratory data, and/or liver imaging, and/or endoscopic findings.
Who cannot join
- Common Exclusion criteria for all subjects:
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
- Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).
- Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).
- Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.
- History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
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- Female subjects who are pregnant (positive pregnancy test at screening or at baseline) or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
- Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).
- Symptoms or history of encephalopathy (Stage III or worse) within three months prior to dosing.
- Clinical evidence of severe ascites. Exclusion criteria
- Common Exclusion criteria for all subjects:
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
- Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).
- Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).
- Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.
- History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
- Female subjects who are pregnant (positive pregnancy test at screening or at baseline) or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
- Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).
- Symptoms or history of encephalopathy (Stage III or worse) within three months prior to dosing.
- Clinical evidence of severe ascites.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
McGuire Research Institute VAMC
Richmond, Virginia, 23249
About this study
Official title: A Phase I, Open-label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
- Conditions
- Hepatic Cirrhosis, Alcoholism
- Being tested
- Pasireotide
- Keywords
- Pasireotide, PK profile,, Single dose, Pasireotide subcutaneous injection, Safety, Mild hepatic impaired patients, Moderate hepatic impaired patients, Severe hepatic impaired patients
- Medical subject headings
- Liver Cirrhosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
Single subcutaneous injection of 600 µg of Pasireotide.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide | Experimental | Not described Receives: Drug: Pasireotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.
Measured: 5 days
Secondary outcomes (1)
Determination of the safety after a single dose of pasireotide s.c. injection
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic CirrhosisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticlas, Study director, Novartis Pharmaceuticlas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698464
- Sponsor's protocol ID
- CSOM230B2114
- Status last verified
- Nov 2016
- First submitted
- 11 Jun 2008
- Last updated
- 21 Dec 2020
- Results posted
- No
Publications
Horsmans Y, Hu K, Ruffin M, Wang Y, Song D, Bouillaud E, Wang Y, Mazur D, Botha FP, Heuman DM. Effect of hepatic impairment on the pharmacokinetics of pasireotide (SOM230): results from a multicenter phase I study. J Clin Pharmacol. 2012 Apr;52(4):552-8. doi: 10.1177/0091270011400072. Epub 2012 Jan 26.
PubMed 22282526
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
- ClinicalTrials.gov ID
- NCT00698464
- Acronym / sponsor ID
- CSOM230B2114
- Conditions
- Hepatic Cirrhosis, Alcoholism
- Keywords
- Pasireotide, PK profile,, Single dose, Pasireotide subcutaneous injection, Safety, Mild hepatic impaired patients, Moderate hepatic impaired patients, Severe hepatic impaired patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- First posted
- 17 Jun 2008 (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 purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide | Experimental | Drug: Pasireotide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects between 18 and 75 years of age, inclusive.
- Vital signs at screening and baseline which are within normal ranges.
- Subjects must have a BMI between 20 kg/m2 and 30 kg/m2.
- Generally healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram and standard laboratory tests at screening.
- Subjects with confirmed cirrhosis by at least one of the following criteria:
Key exclusion criteria (22 listed)
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
- Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).
- Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).
- Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.
- History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
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 |
|---|---|---|
| PasireotideSingle subcutaneous injection of 600 µg of Pasireotide. | Drug | Pasireotide |
Primary outcome
Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.
Time frame: 5 days
1 secondary outcome
Determination of the safety after a single dose of pasireotide s.c. injection
Time frame: 5 days
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 21 Dec 2020.
- Results publication: PubMed 22282526Horsmans Y, Hu K, Ruffin M, Wang Y, Song D, Bouillaud E, Wang Y, Mazur D, Botha FP, Heuman DM. Effect of hepatic impairment on the pharmacokinetics of pasireotide (SOM230): results from a multicenter phase I study. J Clin Pharmacol. 2012 Apr;52(4):552-8. doi: 10.1177/0091270011400072. Epub 2012 Jan 26.
- Novartis Clinical Trial Results on CSOM230B2114Link provided by the sponsor.
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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.
Novartis Pharmaceuticlas study director
Novartis Pharmaceuticlas
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pasireotide in people with Hepatic Cirrhosis and Alcoholism, run by Novartis Pharmaceuticals at 4 sites in 4 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 8 inclusion and 22 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 21 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 4 sites in United States, Belgium, Germany, South Africa. 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?
Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698464, which also lists 1 linked publication.
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 21 Dec 2020.