Liver TransplantationPhase 2NCT00080236
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
A Phase 2 study testing IDN-6556 in people with Liver Transplantation and Hepatitis, run by Conatus Pharmaceuticals Inc. at 13 sites in 2 countries.
Trial summary
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Hepatitis, Cholestasis
- What is being tested?
- IDN-6556
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Nov 2003to Jan 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum adult age
Who cannot join
- Fulminant hepatic failure (UNOS Status I patients)
- Previous liver transplantation
- Patients undergoing split liver grafts
- Extrahepatic malignancy
- If female, pregnant or lactating
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Baylor Regional Transplant Institute, Baylor University Medical Center
Dallas, Texas, 75246
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of California Los Angeles
Los Angeles, California, 90095
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Mount Sinai School of Medicine
New York, New York, 10029
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
Germany3 sites
Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow
Berlin, D-13353
Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover
Hanover, D-30623
Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz
Mainz, 55101
About this study
Official title: Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
Read the detailed description
The occurrence of apoptosis in liver ischemia/reperfusion injury has been well characterized in animal models. In this context apoptosis has specifically been observed in sinusoidal endothelial cells and hepatocytes, and this has also been associated with an increase in activated caspase-3 in liver tissue extracts. The use of caspase inhibitors to prevent apoptosis during liver storage and transplantation may reduce ischemia/reperfusion injury and hence improve graft function after transplantation. Suppression of apoptosis by caspase inhibitors may also allow for longer ischemic times allowing organs to be transported greater distances. In addition, suppression of apoptosis may lower the risk involved in using suboptimal donor organs.
- Being tested
- IDN-6556, Placebo
- Keywords
- Liver Transplantation
- Medical subject headings
- Hepatitis, Cholestasis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDN-6556Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Donor organ placebo and Recipient placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo | Active comparator | Not described Receives: Drug: IDN-6556; Drug: Placebo |
| Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg | Active comparator | Not described Receives: Drug: IDN-6556 |
| Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg | Active comparator | Not described Receives: Drug: IDN-6556 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2004 (estimated)
- Study startNov 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Idun Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080236
- Sponsor's protocol ID
- CL-000006556-PRO-0006
- Status last verified
- Aug 2012
- First submitted
- 24 Mar 2004
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
- ClinicalTrials.gov ID
- NCT00080236
- Acronym / sponsor ID
- CL-000006556-PRO-0006
- Keywords
- Liver Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Idun Pharmaceuticals
- Study start
- Nov 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 26 Mar 2004 (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 the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
Detailed description
The occurrence of apoptosis in liver ischemia/reperfusion injury has been well characterized in animal models. In this context apoptosis has specifically been observed in sinusoidal endothelial cells and hepatocytes, and this has also been associated with an increase in activated caspase-3 in liver tissue extracts. The use of caspase inhibitors to prevent apoptosis during liver storage and transplantation may reduce ischemia/reperfusion injury and hence improve graft function after transplantation. Suppression of apoptosis by caspase inhibitors may also allow for longer ischemic times allowing organs to be transported greater distances. In addition, suppression of apoptosis may lower the risk involved in using suboptimal donor organs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Donor organ placebo and Recipient placebo | Placebo comparator | Drug: Placebo |
| Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo | Active comparator | Drug: IDN-6556, Drug: Placebo |
| Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg | Active comparator | Drug: IDN-6556 |
| Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg | Active comparator | Drug: IDN-6556 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Minimum adult age
Key exclusion criteria (5 listed)
- Fulminant hepatic failure (UNOS Status I patients)
- Previous liver transplantation
- Patients undergoing split liver grafts
- Extrahepatic malignancy
- If female, pregnant or lactating
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 |
|---|---|---|
| IDN-6556 | Drug | Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo, Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg, Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg |
| Placebo | Drug | Donor organ placebo and Recipient placebo, Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo |
Primary outcome
Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation
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 10 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 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 IDN-6556 in people with Liver Transplantation and Hepatitis, run by Conatus Pharmaceuticals Inc. at 13 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 1 inclusion and 5 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, 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. Some participants in this study may receive a placebo. 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?
Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation. The study lists 2 primary outcomes in all. 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 10 Aug 2012.