Hepatitis CPhase 3NCT00466219
Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
A Phase 3 study testing Ribavirin and Pegylated interferon alpha2a in people with Hepatitis C, run by University Hospital, Geneva.
Trial summary
The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Ribavirin and Pegylated interferon alpha2a
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Dec 2006
- Phase
- Phase 3
- 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
- 18 to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV
- patients presenting after LT with recurrent HCV infection, documented by presence of HCV RNA in serum, and recurrent hepatitis, diagnosed at histology; the liver biopsy upon which the diagnosis is established must have been performed within the 12 months prior to inclusion; the treatment cannot start within the 6 months following LT
- alpha fetoprotein value within normal limits obtained within 3 months before entry visit
- stable immunosuppressive regimen, defined as lack of any therapeutic measures aimed at preventing or treating graft rejection during the three months prior to antiviral therapy
Who cannot join
- participation in other clinical trial within 30 days of entry into this protocol
- patients retransplanted for rejection or for recurrent hepatitis C on the graft
- patients with a history of cardiovascular disease including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure are excluded
- presence of HBsAg and/or HIV
- history of auto-immune disease, including auto-immune hepatitis
- alcohol consumption exceeding 40 grams per day
Show all 28Show fewer
- acute rejection episode within the 3 months prior to inclusion, or current histological features possibly related to underlying rejection
- hepatocellular carcinoma
- unresolved biliary complication
- renal insufficiency (serum creatinine levels above 200 micromol/l)
- unconjugated bilirubin blood level > 100 micromol/l
- gammaglutamyl transferase > 20 times the upper limit of normal range
- prothrombin time below 60% of control (except in case of oral anti-coagulant therapy)
- neutrophil count less than 1,500/mm3
- platelet count less than 90,000/mm3
- hemoglobin below the lower limit of normal of the testing laboratory
- other organ or bone marrow transplantation
- current neoplasm and/or anti-tumor chemotherapy
- current hepatic arterial thrombosis
- pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy
- psychosis or anti-depressant therapy for uncontrolled clinical depression
- clinically significant retinal abnormalities
- thyroid dysfunction (abnormal TSH value with or without clinical symptoms)
- immunosuppressive therapy with OKT3 or any other anti-lymphocyte serum
- drug abuse (heroin, cocaine) or substitution therapy during the 12 months prior to inclusion
- history of ischemic cardiopathy
- interstitial pneumonitis
- previous auto-immune hemolysis and all causes of chronic hemolysis
About this study
The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.
Read the detailed description
The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to all patients with histologically documented hepatitis C recurring after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and irrespectively of the pattern of response to a previous antiviral treatment (if any).
The benefit will be assessed in terms of biochemical (normalization of serum transaminases levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of the histological signs of hepatitis) response. The presence of a sustained virological response, as defined below in section 6, will also be studied in relation to the early kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C patients, which suggest that an early rapid decrease of HCV viremia is associated with a durable response.
- Conditions
- Hepatitis C
- Being tested
- Ribavirin, Pegylated interferon alpha2a
- Keywords
- Presence of HCV RNA in serum, Absence of graft rejection, Recurrent hepatitis C after liver transplantation
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Pegylated interferon alpha2aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical (normalization of serum transaminases levels),
virological (disappearance of HCV RNA from serum)
and histological (amelioration of the histological signs of hepatitis) response.
Secondary outcomes (1)
Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2002
- Study completionDec 2006
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.
- More trials run by University Hospital, GenevaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Negro, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466219
- Sponsor's protocol ID
- SASL17
- Status last verified
- Apr 2007
- First submitted
- 25 Apr 2007
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
- ClinicalTrials.gov ID
- NCT00466219
- Acronym / sponsor ID
- SASL17
- Conditions
- Hepatitis C
- Keywords
- Presence of HCV RNA in serum, Absence of graft rejection, Recurrent hepatitis C after liver transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Apr 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.
The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.
Detailed description
The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to all patients with histologically documented hepatitis C recurring after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and irrespectively of the pattern of response to a previous antiviral treatment (if any).
The benefit will be assessed in terms of biochemical (normalization of serum transaminases levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of the histological signs of hepatitis) response. The presence of a sustained virological response, as defined below in section 6, will also be studied in relation to the early kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C patients, which suggest that an early rapid decrease of HCV viremia is associated with a durable response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV
- patients presenting after LT with recurrent HCV infection, documented by presence of HCV RNA in serum, and recurrent hepatitis, diagnosed at histology; the liver biopsy upon which the diagnosis is established must have been performed within the 12 months prior to inclusion; the treatment cannot start within the 6 months following LT
- alpha fetoprotein value within normal limits obtained within 3 months before entry visit
- stable immunosuppressive regimen, defined as lack of any therapeutic measures aimed at preventing or treating graft rejection during the three months prior to antiviral therapy
Key exclusion criteria (28 listed)
- participation in other clinical trial within 30 days of entry into this protocol
- patients retransplanted for rejection or for recurrent hepatitis C on the graft
- patients with a history of cardiovascular disease including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure are excluded
- presence of HBsAg and/or HIV
- history of auto-immune disease, including auto-immune hepatitis
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 |
|---|---|---|
| Ribavirin | Drug | – |
| Pegylated interferon alpha2a | Drug | – |
Primary outcome
Biochemical (normalization of serum transaminases levels),
virological (disappearance of HCV RNA from serum)
and histological (amelioration of the histological signs of hepatitis) response.
1 secondary outcome
Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).
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 27 Apr 2007.
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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.
Francesco Negro, MD principal investigator
University Hospital, Geneva
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribavirin and Pegylated interferon alpha2a in people with Hepatitis C, run by University Hospital, Geneva.
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 28 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 27 Apr 2007. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Biochemical (normalization of serum transaminases levels),. The study lists 3 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 27 Apr 2007.