Liver TransplantPhase 4NCT00275548
Safety and Effectiveness Using Pegasys and Copegus in Recipients of Liver Transplantation With Hepatitis C
A Phase 4 study testing Pegasys and Copegus in people with Liver Transplant and Hepatitis C, run by Mayo Clinic at 1 site in United States.
Trial summary
The study is being done to study the impact of prophylactic administration of antiviral therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection in liver transplant recipients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Transplant, Hepatitis C
- What is being tested?
- Pegasys and Copegus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Apr 2009
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive HCV RNA by PCR at pretransplantation. No biochemical inclusion criteria Male or female patient (>18 yrs) who has undergone liver transplantation because of liver cirrhosis attributed to HCV infection. Patient is a primary, single organ recipient (cadaveric donor). Normal thyroid-stimulating hormone (TSH) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Documentation that female patients of childbearing potential and all male patients are practicing two methods of contraception. For male participants, the following methods are acceptable: 1) vasectomy ANDcondoms with spermicide or 2) vasectomy or condoms with spermicide AND a monogamous relationship with a woman using a single method of contraception. Liver transplant >10 weeks and <26 weeks (6 months) before treatment initiation Patients with a pre-OLT diagnosis of hepatocellular carcinoma (HCC) may be enrolled provided there is no evidence of extrahepatic spread or vascular invasion, and the tumor is solitary and <5 cm or there are up to three tumors <3 cm.
Who cannot join
- Multi-organ or retransplant recipient Patients with HCC who do not meet inclusion criteria or require systemic chemotherapy Recipient of ABO incompatible organ Donor cold ischemia time >20 hrs Anti-HBc positive donor Histological evidence of unresolved rejection Episode of steroid resistant rejection / use of OKT3 Evidence of current Hepatitis B (sAg, cAb, IgM) Seropositivity for HIV infection Serum creatinine >2x upper limit of normal WBC >20,000 x 109/L or ANC <1,500 cells/mm3 Hgb <10g/dL and/or platelets <50,000/mm3 History of autoimmune disease (SLE, scleroderma, rheumatoid arthritis etc.) Uncontrolled seizure disorder Uncontrolled depression or history of suicide attempts/ideation History or evidence of retinopathy Unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multi-center, Open-label, Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon Alfa-2a(Pegasys) Plus Ribavirin vs. No Prophylaxis Following Liver Transplantation for Hepatitis C.
The study is being done to study the impact of prophylactic administration of antiviral therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection in liver transplant recipients.
Read the detailed description
This is a multicenter, prospective, randomized, open-label efficacy and safety study. The study is being done to see whether treatment using Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin) is safer and more effective in liver transplant recipients when given before hepatitis C infection reappears, or when it is given after clinical symptoms of hepatitis C reinfection appear. The study is also being done in liver transplant recipients to estimate how much hepatitis C is detected over time, how the body affects the study drugs, the safety of the study drugs whether or not the study drugs effect the participants' quality of life, and whether or not the participants feel more or less depressed as a result.
Participants will be put into one of two groups. In the preventive group; participants will receive study drugs for the treatment of recurring (or returning) hepatitis C before developing actual clinical symptoms. The participants in the observational groups will receive study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis c infection.
This study will have four parts: a screening phrase, a treatment/observational phrase, follow-up phase and long term safety follow-up phase. Throughout all four stages of the study, participants will have physical exams, medical and surgical history's will be taken, blood and urine tests, eye exam, liver biopsy, chest x-ray and electrocardiogram (ECG). If participants are female, a pregnancy test will also be performed. Participants must also agree not to drink any alcoholic beverages or take any other drugs for hepatitis c infection while taking part in the study. Participants must be able to return for clinic visits at scheduled intervals.
- Conditions
- Liver Transplant, Hepatitis C
- Being tested
- Pegasys, Copegus
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegasysDrug
Also called peginterferon alfa-2a, Ro25-8310)
135-180 micrograms administered sc once weekly
CopegusDrug
Also called (ribavirin, Ro20-9963)
400-1200 mg/day for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| The Preventative (Prophylaxis) Group: | Other | This group of patients will receive study drugs for the treatment of recurring (or returning) hepatitis C before they actually develop clinical symptoms of hepatitis C. Receives: Drug: Pegasys; Drug: Copegus |
| The Observational Group: | Other | This group of patients will receive the study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis C infection. Receives: Drug: Pegasys; Drug: Copegus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in each group who experienced histologically confirmed recurrence of HCV at 120 weeks post randomization.
Measured: 96 weeks
Secondary outcomes (5)
The proportion of patients who have non-detectable serum HCV-RNA measured by Quanta Sure plus HCV test and HCV RNA negative by quantitative PCR at week 12, 24, and 48 following initiation of treatment or on observation.
Measured: 96 weeks
Virological response rate to antiviral therapy at week 12, week 24, and week 48 of therapy among patients who received antiviral therapy in either study arm.
Measured: 96 weeks
Sustained virological response rate: the virological response at the conclusion of the 24 weeks treatment free follow-up period or 72 weeks on observation (for patients who received no treatment).
Measured: 96 weeks
The virological response at the conclusion of the 24 weeks treatment-free follow-up period among patients who received antiviral therapy in either arm of the study.
Measured: 96 weeks
Patient death or graft failure (as indicated by retransplantation).
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startJul 2004
- Primary completionJun 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Michael R. Charlton, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275548
- Sponsor's protocol ID
- 1404-04
- Status last verified
- Nov 2011
- First submitted
- 10 Jan 2006
- Last updated
- 11 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center, Open-label, Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon Alfa-2a(Pegasys) Plus Ribavirin vs. No Prophylaxis Following Liver Transplantation for Hepatitis C.
- ClinicalTrials.gov ID
- NCT00275548
- Acronym / sponsor ID
- 1404-04
- Conditions
- Liver Transplant, Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jul 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Jan 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.
The study is being done to study the impact of prophylactic administration of antiviral therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection in liver transplant recipients.
Detailed description
This is a multicenter, prospective, randomized, open-label efficacy and safety study. The study is being done to see whether treatment using Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin) is safer and more effective in liver transplant recipients when given before hepatitis C infection reappears, or when it is given after clinical symptoms of hepatitis C reinfection appear. The study is also being done in liver transplant recipients to estimate how much hepatitis C is detected over time, how the body affects the study drugs, the safety of the study drugs whether or not the study drugs effect the participants' quality of life, and whether or not the participants feel more or less depressed as a result.
Participants will be put into one of two groups. In the preventive group; participants will receive study drugs for the treatment of recurring (or returning) hepatitis C before developing actual clinical symptoms. The participants in the observational groups will receive study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis c infection.
This study will have four parts: a screening phrase, a treatment/observational phrase, follow-up phase and long term safety follow-up phase. Throughout all four stages of the study, participants will have physical exams, medical and surgical history's will be taken, blood and urine tests, eye exam, liver biopsy, chest x-ray and electrocardiogram (ECG). If participants are female, a pregnancy test will also be performed. Participants must also agree not to drink any alcoholic beverages or take any other drugs for hepatitis c infection while taking part in the study. Participants must be able to return for clinic visits at scheduled intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Preventative (Prophylaxis) Group: | Other | Drug: Pegasys, Drug: CopegusThis group of patients will receive study drugs for the treatment of recurring (or returning) hepatitis C before they actually develop clinical symptoms of hepatitis C. |
| The Observational Group: | Other | Drug: Pegasys, Drug: CopegusThis group of patients will receive the study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis C infection. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive HCV RNA by PCR at pretransplantation. No biochemical inclusion criteria Male or female patient (>18 yrs) who has undergone liver transplantation because of liver cirrhosis attributed to HCV infection. Patient is a primary, single organ recipient (cadaveric donor). Normal thyroid-stimulating hormone (TSH) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Documentation that female patients of childbearing potential and all male patients are practicing two methods of contraception. For male participants, the following methods are acceptable: 1) vasectomy ANDcondoms with spermicide or 2) vasectomy or condoms with spermicide AND a monogamous relationship with a woman using a single method of contraception. Liver transplant >10 weeks and <26 weeks (6 months) before treatment initiation Patients with a pre-OLT diagnosis of hepatocellular carcinoma (HCC) may be enrolled provided there is no evidence of extrahepatic spread or vascular invasion, and the tumor is solitary and <5 cm or there are up to three tumors <3 cm.
Key exclusion criteria (1 listed)
- Multi-organ or retransplant recipient Patients with HCC who do not meet inclusion criteria or require systemic chemotherapy Recipient of ABO incompatible organ Donor cold ischemia time >20 hrs Anti-HBc positive donor Histological evidence of unresolved rejection Episode of steroid resistant rejection / use of OKT3 Evidence of current Hepatitis B (sAg, cAb, IgM) Seropositivity for HIV infection Serum creatinine >2x upper limit of normal WBC >20,000 x 109/L or ANC <1,500 cells/mm3 Hgb <10g/dL and/or platelets <50,000/mm3 History of autoimmune disease (SLE, scleroderma, rheumatoid arthritis etc.) Uncontrolled seizure disorder Uncontrolled depression or history of suicide attempts/ideation History or evidence of retinopathy Unable or unwilling to give informed consent
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 |
|---|---|---|
| PegasysAlso: peginterferon alfa-2a, Ro25-8310)135-180 micrograms administered sc once weekly | Drug | The Observational Group:, The Preventative (Prophylaxis) Group: |
| CopegusAlso: (ribavirin, Ro20-9963)400-1200 mg/day for 48 weeks | Drug | The Observational Group:, The Preventative (Prophylaxis) Group: |
Primary outcome
The proportion of patients in each group who experienced histologically confirmed recurrence of HCV at 120 weeks post randomization.
Time frame: 96 weeks
5 secondary outcomes
The proportion of patients who have non-detectable serum HCV-RNA measured by Quanta Sure plus HCV test and HCV RNA negative by quantitative PCR at week 12, 24, and 48 following initiation of treatment or on observation.
Time frame: 96 weeks
Virological response rate to antiviral therapy at week 12, week 24, and week 48 of therapy among patients who received antiviral therapy in either study arm.
Time frame: 96 weeks
Sustained virological response rate: the virological response at the conclusion of the 24 weeks treatment free follow-up period or 72 weeks on observation (for patients who received no treatment).
Time frame: 96 weeks
The virological response at the conclusion of the 24 weeks treatment-free follow-up period among patients who received antiviral therapy in either arm of the study.
Time frame: 96 weeks
Patient death or graft failure (as indicated by retransplantation).
Time frame: 96 weeks
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 Nov 2011.
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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.
Michael R. Charlton, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegasys and Copegus in people with Liver Transplant and Hepatitis C, run by Mayo Clinic at 1 site in United States.
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 1 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of patients in each group who experienced histologically confirmed recurrence of HCV at 120 weeks post randomization. (time frame: 96 weeks). 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 Nov 2011.