Hepatitis CPhase 2CHASENCT00295607
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
A Phase 2 study testing Tacrolimus and steroids, monoclonal anti-IL2R antibody in people with Hepatitis C and Liver Transplantation, run by Astellas Pharma Inc at 17 sites in 8 countries.
Trial summary
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Liver Transplantation
- What is being tested?
- Tacrolimus and steroids, monoclonal anti-IL2R antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 17 sitesin 8 countries
- Study dates
- Jun 2005to Jun 2008
- 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
- Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
- Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
Who cannot join
- Recipient of multi-organ transplant
- Recipient of an auxiliary graft
- Patient is receiving ABO incompatible graft
- Patients requiring immunosuppressive treatment
- Patients requiring ongoing corticosteroid therapy.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
Show all 10Show fewer
- Patient or donor is known to be HIV positive.
- Patient is allergic or intolerant to study medication
- Patient is pregnant or breast-feeding.
- Patient has been previously enrolled in this study
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
France4 sites
Study site
Besançon, 25030
Study site
Lyon, 69317
Study site
Nice, 06202
Study site
Villejuif, 94804
Germany3 sites
Study site
Berlin, 13353
Study site
Hamburg, 20251
Study site
Mainz, 55131
Spain3 sites
Study site
Barakaldo, 48903
Study site
Madrid, 28035
Study site
Santiago, 15706
About this study
Official title: Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
Read the detailed description
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.
- Conditions
- Hepatitis C, Liver Transplantation
- Being tested
- Tacrolimus, steroids, monoclonal anti-IL2R antibody
- Keywords
- Tacrolimus, Liver Transplantation, Immunosuppression, Adult, Treatment Outcome
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
immunosuppression
steroids, monoclonal anti-IL2R antibodyDrug
immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Tacrolimus; Drug: steroids, monoclonal anti-IL2R antibody |
| 2 | Experimental | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load of HCV at 12 months post transplantation
Measured: 12 months
Secondary outcomes (4)
Biopsy-proven acute rejection
Measured: 12 months
Acute rejection
Measured: 12 months
Patient and graft survival
Measured: 12 months
Incidence of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startJun 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Physician, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295607
- Sponsor's protocol ID
- FG-506-01-28
- Acronym
- CHASE
- Status last verified
- Sep 2011
- First submitted
- 22 Feb 2006
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation
- ClinicalTrials.gov ID
- NCT00295607
- Acronym / sponsor ID
- CHASE / FG-506-01-28
- Conditions
- Hepatitis C, Liver Transplantation
- Keywords
- Tacrolimus, Liver Transplantation, Immunosuppression, Adult, Treatment Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Feb 2006 (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 is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
Detailed description
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tacrolimus, Drug: steroids, monoclonal anti-IL2R antibody |
| 2 | Experimental | Drug: Tacrolimus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
- Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
Key exclusion criteria (10 listed)
- Recipient of multi-organ transplant
- Recipient of an auxiliary graft
- Patient is receiving ABO incompatible graft
- Patients requiring immunosuppressive treatment
- Patients requiring ongoing corticosteroid therapy.
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 |
|---|---|---|
| TacrolimusAlso: Prograf, FK506immunosuppression | Drug | 1, 2 |
| steroids, monoclonal anti-IL2R antibodyimmunosuppression | Drug | 1 |
Primary outcome
Viral load of HCV at 12 months post transplantation
Time frame: 12 months
4 secondary outcomes
Biopsy-proven acute rejection
Time frame: 12 months
Acute rejection
Time frame: 12 months
Patient and graft survival
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
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 11 Apr 2013.
- Link to FDA WebsiteLink 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.
Medical Physician study director
Astellas Pharma Europe B.V.
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus and steroids, monoclonal anti-IL2R antibody in people with Hepatitis C and Liver Transplantation, run by Astellas Pharma Inc at 17 sites in 8 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 2 inclusion and 10 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Germany, Italy, Spain, Czechia and 3 more countries. 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?
Viral load of HCV at 12 months post transplantation (time frame: 12 months). 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 11 Apr 2013.