Liver TransplantationEarly Phase 1NCT01909401
Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
A Early Phase 1 study testing boceprevir in people with Liver Transplantation, run by Indiana University at 1 site in United States.
Trial summary
Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transplantation may… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- boceprevir
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2014
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18-70
- Patients must be genotype I HCV-infected individuals with cirrhosis undergoing orthotopic liver transplantation.
- Those with hepatocellular carcinoma with or without treatment of hepatoma may also be included.
- The MELD score for enrollment will be capped at 16.
- Patients must have medically controlled ascites and those who have moderate or poorly controlled ascites will be excluded.
- ALT (alanine aminotransferase) < 250 IU/L, AST (Aspartate aminotransferase ) < 250 IU/L, total bilirubin < 3 mg/dl, creatinine clearance > 45 ml by MDRD (Modification of Diet in Renal Disease), albumin > 2.8 g/dl, hemoglobin > 11, white count > 2.0 X103, absolute neutrophil count 1.5 X103, platelet count > 50,000.
- Women of childbearing potential and male patients with sexual female partner who is of childbearing potential should use two acceptable methods of contraception.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine - IUHealth-University Hospital
Indianapolis, Indiana, 46202
About this study
Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transplantation may successfully get rid of their virus before the transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect the new liver that they receive and they will not require therapy for Hepatitis C after liver transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and boceprevir, all of which are approved for the treatment of genotype I Hepatitis C.
Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic liver transplantation will lead to rapid HCV RNA clearance of genotype I infected individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new transplanted graft and prevent graft infection posttransplantation.
Read the detailed description
Subject Patient Inclusion Criteria: Men and women age 18 to 70 inclusive, patients with genotype I Hepatitis C who are listed for orthotopic liver transplantation (OLT) will be enrolled. Those with hepatocellular carcinoma with or without treatment of hepatoma may also be included. The MELD score for enrollment will be capped at 16. Patients must have medically controlled ascites and those who have moderate or poorly controlled ascites will be excluded.
Treatment Plan: Fifteen patients with chronic genotype I Hepatitis C will be enrolled. All patients will begin with peginterferon and ribavirin for 4 weeks with the addition of boceprevir after Week 4 until orthotopic liver transplantation. The dose of interferon will be peginterferon 1.0 mcg/kg with weight-based ribavirin (600-1200 mg) with boceprevir 800 mg TID (three times per day) until OLT. All patients will be listed for orthotopic liver transplantation. HCV RNA will be measured monthly. When they are called in for transplant, they will take their last dose of ribavirin just prior to going to operating room. Patients will undergo orthotopic liver transplantation under standard protocol by Indiana University. They will receive by Dobhoff boceprevir 800 tid for 3 doses post transplantation. Virologic failure will be HCV RNA > 100 I.U. at Week 12.
- Conditions
- Liver Transplantation
- Being tested
- boceprevir
- Keywords
- Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
boceprevirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir.
The primary objective is to determine the number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir. The primary safety objective is to determine the safety and efficacy of peginterferon, ribavirin, and boceprevir in Hepatitis C, genotype I individuals undergoing orthotopic liver transplantation.
Measured: 6 months post orthotopic liver transplant
Secondary outcomes (1)
Safety and efficacy of peginterferon, ribavirin, and boceprevir in patients with genotype I undergoing orthotopic liver transplant for cirrhosis and/or hepatocellular carcinoma.
To determine the safety and efficacy of peginterferon, ribavirin, and boceprevir in patients with genotype I undergoing orthotopic liver transplant for cirrhosis and/or hepatocellular carcinoma as defined by incidence of severe infections (SBP, bacteremia) and new onset ascites and or encephalopahty.
Measured: 6 months post orthotopic liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
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.
- More trials run by Indiana UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Paul Y Kwo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909401
- Sponsor's protocol ID
- 1301010500
- Status last verified
- Jul 2014
- First submitted
- 13 Jun 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT01909401
- Acronym / sponsor ID
- 1301010500
- Conditions
- Liver Transplantation
- Keywords
- Liver Transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jul 2013 (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.
Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transplantation may successfully get rid of their virus before the transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect the new liver that they receive and they will not require therapy for Hepatitis C after liver transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and boceprevir, all of which are approved for the treatment of genotype I Hepatitis C.
Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic liver transplantation will lead to rapid HCV RNA clearance of genotype I infected individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new transplanted graft and prevent graft infection posttransplantation.
Detailed description
Subject Patient Inclusion Criteria: Men and women age 18 to 70 inclusive, patients with genotype I Hepatitis C who are listed for orthotopic liver transplantation (OLT) will be enrolled. Those with hepatocellular carcinoma with or without treatment of hepatoma may also be included. The MELD score for enrollment will be capped at 16. Patients must have medically controlled ascites and those who have moderate or poorly controlled ascites will be excluded.
Treatment Plan: Fifteen patients with chronic genotype I Hepatitis C will be enrolled. All patients will begin with peginterferon and ribavirin for 4 weeks with the addition of boceprevir after Week 4 until orthotopic liver transplantation. The dose of interferon will be peginterferon 1.0 mcg/kg with weight-based ribavirin (600-1200 mg) with boceprevir 800 mg TID (three times per day) until OLT. All patients will be listed for orthotopic liver transplantation. HCV RNA will be measured monthly. When they are called in for transplant, they will take their last dose of ribavirin just prior to going to operating room. Patients will undergo orthotopic liver transplantation under standard protocol by Indiana University. They will receive by Dobhoff boceprevir 800 tid for 3 doses post transplantation. Virologic failure will be HCV RNA > 100 I.U. at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women age 18-70
- Patients must be genotype I HCV-infected individuals with cirrhosis undergoing orthotopic liver transplantation.
- Those with hepatocellular carcinoma with or without treatment of hepatoma may also be included.
- The MELD score for enrollment will be capped at 16.
- Patients must have medically controlled ascites and those who have moderate or poorly controlled ascites will be excluded.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| boceprevir | Drug | – |
Primary outcome
Number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir.
Time frame: 6 months post orthotopic liver transplant
The primary objective is to determine the number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir. The primary safety objective is to determine the safety and efficacy of peginterferon, ribavirin, and boceprevir in Hepatitis C, genotype I individuals undergoing orthotopic liver transplantation.
1 secondary outcome
Safety and efficacy of peginterferon, ribavirin, and boceprevir in patients with genotype I undergoing orthotopic liver transplant for cirrhosis and/or hepatocellular carcinoma.
Time frame: 6 months post orthotopic liver transplant
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 24 Jul 2014.
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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.
Paul Y Kwo, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing boceprevir in people with Liver Transplantation, run by Indiana University 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 7 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 24 Jul 2014. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir. (time frame: 6 months post orthotopic liver transplant). 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 24 Jul 2014.