Liver FibrosisPhase 1NCT00896233

Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)

A Phase 1 study testing MRE in people with Liver Fibrosis and Hepatitis C Virus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an alternative to liver biopsy. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Liver Fibrosis, Hepatitis C Virus
What is being tested?: MRE
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Aug 2009to Jan 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female and at least 18 years of age
Generally good health
Willing to fast for 8 hours prior to each study visit
Hepatitis C Virus (HCV) Inclusion Criteria:
Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;
For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)

Show all 9Show fewer

Never been treated for HCV
Healthy Participant Inclusion Criteria:
Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening

Who cannot join

History of stroke, seizures, or neurological disorders
Consumption of excessive amounts of alcohol
Use of products containing nicotine
Unable to hold a breath for 20 seconds
Claustrophobia
Use of illicit drugs or history of drug or alcohol abuse

Show all 9Show fewer

HCV-Positive Exclusion Criteria:
Evidence or history of chronic hepatitis not caused by HCV
HIV

About this study

Official title: Test-Retest Repeatability Study of Magnetic Resonance Elastography (MRE) for Liver Fibrosis Assessment in Healthy Volunteers and Hepatitis C Virus-Infected Patients

Conditions: Liver Fibrosis, Hepatitis C Virus
Being tested: MRE
Keywords: Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus
Medical subject headings: Liver Cirrhosis, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MREProcedure or surgery
Part 1: Participants will have a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit will consist of two liver MRE scans.
Part 2: Participants will have a screening visit, followed ~1
month later by one imaging visit. The imaging visit will consist
of two liver MRE scans.

Study groups in NCT00896233
Study group	Role	What they receive
MRE	Experimental	Not described Receives: Procedure: MRE

What is being measured

The primary outcome is the main question the study is designed to answer.

Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.
Measured: 14 days
Repeated Mean Liver Elastic Stiffness (kPa) Measurements
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.
Measured: 14 days
Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.
Measured: 14 days
Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Jan 2010

First posted11 May 2009 (estimated)
Study startAug 2009
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver FibrosisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00896233
Sponsor's protocol ID: 0000-132
Other IDs: 2009_588
Status last verified: Aug 2015
First submitted: 7 May 2009
Last updated: 25 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shire NJ, Yin M, Chen J, Railkar RA, Fox-Bosetti S, Johnson SM, Beals CR, Dardzinski BJ, Sanderson SO, Talwalkar JA, Ehman RL. Test-retest repeatability of MR elastography for noninvasive liver fibrosis assessment in hepatitis C. J Magn Reson Imaging. 2011 Oct;34(4):947-55. doi: 10.1002/jmri.22716. Epub 2011 Jul 12.
PubMed 21751289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Liver Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Test-Retest Repeatability Study of Magnetic Resonance Elastography (MRE) for Liver Fibrosis Assessment in Healthy Volunteers and Hepatitis C Virus-Infected Patients
ClinicalTrials.gov ID: NCT00896233
Acronym / sponsor ID: 0000-132
Conditions: Liver Fibrosis, Hepatitis C Virus
Keywords: Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 11 May 2009 (estimated)
Results: Posted 22 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MRE	Experimental	Procedure: MRE

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female and at least 18 years of age
Generally good health
Willing to fast for 8 hours prior to each study visit
Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;
For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)

Key exclusion criteria (9 listed)

History of stroke, seizures, or neurological disorders
Consumption of excessive amounts of alcohol
Use of products containing nicotine
Unable to hold a breath for 20 seconds
Claustrophobia

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
MREPart 1: Participants will have a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit will consist of two liver MRE scans. Part 2: Participants will have a screening visit, followed ~1 month later by one imaging visit. The imaging visit will consist of two liver MRE scans.	Procedure or surgery	MRE

Primary outcome

Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
Time frame: 14 days
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.
Repeated Mean Liver Elastic Stiffness (kPa) Measurements
Time frame: 14 days
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.
Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants
Time frame: 14 days
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.
Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants
Time frame: 14 days
Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.

Results and safety

Results posted to the registry on 22 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Magnetic Resonance Elastography (MRE)	10	9

Primary outcome: Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements

Time frame: 14 days. Mean (Standard Deviation). Unit: kPa

Measure	Reader 1 n = 9	Reader 2 n = 9
MRE Common ROI	4.54 (0.48)	4.64 (0.50)
MRE Individual ROI	5.10 (0.44)	5.14 (0.41)

Reader 1: ICC: 0.90 (90% CI 0.81 to 0.99)
Reader 2: ICC: 0.85 (90% CI 0.71 to 0.98)
Reader 1: ICC: 0.88 (90% CI 0.78 to 0.98)

Population analysed: Participants analyzed were Completers.

Primary outcome: Repeated Mean Liver Elastic Stiffness (kPa) Measurements

Time frame: 14 days. Mean (Standard Deviation). Unit: kPa

Measure	Reader 1 n = 9	Reader 2 n = 9
MRE Common ROI	3.12 (0.26)	3.14 (0.31)
MRE Individual ROI	3.08 (0.19)	3.15 (0.20)

Reader 1: ICC: 0.90 (90% CI 0.80 to 0.99)
Reader 2: ICC: 0.88 (90% CI 0.78 to 0.99)
Reader 1: ICC: 0.93 (90% CI 0.87 to 1.00)

Population analysed: Participants analyzed were Completers.

Primary outcome: Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants

Time frame: 14 days. Number (95% Confidence Interval). Unit: percent treatment difference

Measure	Reader 1 n = 9	Reader 2 n = 9
MRE Common ROI	94.41 (33.85 to 182.36)	94.66 (32.65 to 185.67)
MRE Individual ROI	97.02 (39.77 to 177.73)	99.31 (37.81 to 188.27)

Population analysed: Participants analyzed were Completers.

Primary outcome: Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants

Time frame: 14 days. Number (95% Confidence Interval). Unit: percent treatment difference

Measure	Reader 1 n = 9	Reader 2 n = 9
MRE Common ROI	117.21 (33.70 to 252.87)	91.24 (32.12 to 176.83)
MRE Individual ROI	105.35 (38.51 to 204.42)	90.77 (34.64 to 170.29)

Population analysed: Participants analyzed were Completers.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Magnetic Resonance Elastography (MRE)	0 of 10 (0%)	1 of 10 (10%)	Not reported

Limitations and caveats (from the sponsor): Since both primary objectives were met based on the Part 1 analysis, a decision was made to stop the study and not proceed to Part 2. Therefore, data from Part 1 of the study were used for outcome measures 3 and 4 instead of data from Part 2.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21751289Shire NJ, Yin M, Chen J, Railkar RA, Fox-Bosetti S, Johnson SM, Beals CR, Dardzinski BJ, Sanderson SO, Talwalkar JA, Ehman RL. Test-retest repeatability of MR elastography for noninvasive liver fibrosis assessment in hepatitis C. J Magn Reson Imaging. 2011 Oct;34(4):947-55. doi: 10.1002/jmri.22716. Epub 2011 Jul 12.

Related trials for Liver Fibrosis

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRE in people with Liver Fibrosis and Hepatitis C Virus, run by Merck Sharp & Dohme LLC.

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 9 inclusion and 9 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 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 22 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements (time frame: 14 days). The study lists 4 primary outcomes in all. 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 NCT00896233, 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 25 Aug 2015.