Late Complication From Liver TransplantPhase 3NCT02160080
Boceprevir Treatment in Liver Pre-transplant HCV Patients
A Phase 3 study testing Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin in people with Late Complication From Liver Transplant, run by Hu Tsung-Hui at 1 site in Taiwan.
Trial summary
End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani et. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Late Complication From Liver Transplant
- What is being tested?
- Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Feb 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 20 years and older
- Chronic infection with genotype 1 hepatitis C virus proven with positive PCR
- Liver cirrhosis while awaiting liver transplantation
- Patient with compensated liver functions
- With or without hepatocellular carcinoma.
- Naive or experienced (failure) to HCV antiviral treatmentFailure is defined according to the following terminology:
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- Relapsing patient: HCV RNA undetectable at the end of treatment, becoming detectable again after the discontinuation of treatment
- Breakthrough: increase of viremia of 1 log or more during the treatment
- Non-responding patient with partial response: HCV RNA detectable at W24 without ever having been undetectable and with a decrease in HCV RNA ≥ 2 log at W12
- Non-responding patient with null response: decrease in HCV RNA < 2 log at W12
- No need for prior treatment wash-out
- Written patient informed consent
Who cannot join
- Non controlled sepsis
- Platelets < 50,000/mm3
- Neutrophil granulocyte levels < 1000/mm3
- Creatinine clearance < 50 mL/min
- Hb < 10 g/dL
- Uncontrolled psychiatric problems
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- Hypersensitivity or contraindications to any component of boceprevir formulation
- Contraindication to interferon or ribavirin
- HIV coinfection
- HBV coinfection (unless this is treated effectively with analogues, as proven by undetectable viremia for at least 12 months)
- Other infectious disease underway
- Neoplastic disease other than hepatocellular carcinoma during the previous year, or neoplastic disease for which the prognosis is less than 3 years
- Treatment with immunosuppressors (including corticosteroids), antivirals other than those for the study, except aciclovir
- Current or anticipated use of any of the following prohibited medications: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives
- Person participating in another study including an exclusion period that is still underway during pre-enrollment
- Pregnancy, breast-feeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
123, Ta Pei Road, Niao Sung Hsiang
Kaohsiung Hsien, 833
Tsung-Hui Hu, Ph.D, +886 7 7317123 ext. 8301, dr.hu@msa.hinet.net
Yu-Jean Chen, M's, +886 7 7317123 ext. 2446, beaglelulu@yahoo.com.tw
About this study
End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver transplantation.(Bzowej et al., 2011)
Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease patients awaiting for liver transplantation annually. If the HCV viral load can be significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al, 2011).
We aim to conduct an prospective, open label, single arm study. This study design is single arm to treat HCV patients with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapies before liver transplantation for patients with detectable HCV RNA. The total number of patients would be around 20 cases included in the study and all of them will take Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin. Then after, triple therapy with Boceprevir + Peg-Interferon α-2b + Ribavirin will be used for at least 16 weeks or maximal 44 weeks before transplantation. Normal practice based on the treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will be done before enrollment. Patients will be monitored for all the efficacy and safety endpoints during the treatment period. HCV RNA will be checked at time of transplant. Finally, patients will received regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after liver transplantation.
Read the detailed description
End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver transplantation.(Bzowej et al., 2011)
Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease patients awaiting for liver transplantation annually. If the HCV viral load can be significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy with pegylated interferon alfa (PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al, 2011).
We aim to conduct a prospective, open label, single arm study. This study design is single arm to treat HCV patients with pegylated interferon alfa (PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapies before liver transplantation for patients with detectable HCV RNA. The total number of patients would be around 20 cases included in the study and all of them will take pegylated interferon alfa (PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin, followed by Boceprevir + Peg-Interferon α-2b + Ribavirin for at least 16 weeks or maximal 44 weeks before transplantation. The treatment will be discontinued immediately at time of liver transplantation. Normal practice based on the treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will be done before enrollment.
-Treatment Stopping Rules-
If the patient has HCV RNA >100 IU/ml at week 12 after the beginning of treatment with peg interferon plus ribavirin, i.e. 8 weeks after the initiation of therapy with boceprevir, all HCV medications are to be discontinued.
If the patient has detectable HCV RNA at Week 24 after the beginning of treatment with peg interferon plus ribavirin, i.e. 20 weeks after the initiation of therapy with boceprevir, all HCV medications are to be discontinued.
Monitoring of Patients during Treatment Complete blood counts should be obtained pretreatment, Treatment Week 4, Treatment Week 8, and thereafter, as clinically appropriate. If serum hemoglobin is <10 g/dL, a decrease in dosage of ribavirin and/or administration with erythropoietin (epoetin alfa) may be warranted.
-Primary Outcome Measure: Title: Number of Participants with Adverse Events as a Measure of Safety Time Frame: Up to the time of liver transplant
-Secondary Outcome Measures: Title: HCV-RNA (Hepatitis C virus RNA) level Time Frame: Baseline, Treatment Week 12 , Treatment Week 24. A follow-up test is recommended 24 weeks after the completion of treatment, or at time of liver transplant. Finally, patients will receive regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after liver transplantation.
- Conditions
- Late Complication From Liver Transplant
- Being tested
- Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
- Keywords
- Boceprevir;, Liver pre-transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boceprevir 800mg/TID+Pegylated interferon alfa+RibavirinDrug
Also called Victrelis (Boceprevir)
Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
| Study group | Role | What they receive |
|---|---|---|
| Boc+Peg-int alfa+Rbv | Experimental | Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin Receives: Drug: Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: within 1 year
Secondary outcomes (1)
HCV-RNA (Hepatitis C virus RNA) level
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Complication From Liver TransplantStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hu Tsung-Hui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hu Tsung-Hui, Chang Gung Memorial Hospital
- Investigators
- Tsung-Hui Hu, Ph.D, Principal investigator, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160080
- Sponsor's protocol ID
- IRB:102-4331A
- Status last verified
- Jun 2014
- First submitted
- 11 Apr 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boceprevir Treatment in Liver Pre-transplant HCV Patients
- ClinicalTrials.gov ID
- NCT02160080
- Acronym / sponsor ID
- IRB:102-4331A
- Conditions
- Late Complication From Liver Transplant
- Keywords
- Boceprevir;, Liver pre-transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hu Tsung-HuiUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Jun 2014 (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.
End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver transplantation.(Bzowej et al., 2011)
Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease patients awaiting for liver transplantation annually. If the HCV viral load can be significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al, 2011).
We aim to conduct an prospective, open label, single arm study. This study design is single arm to treat HCV patients with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapies before liver transplantation for patients with detectable HCV RNA. The total number of patients would be around 20 cases included in the study and all of them will take Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin. Then after, triple therapy with Boceprevir + Peg-Interferon α-2b + Ribavirin will be used for at least 16 weeks or maximal 44 weeks before transplantation. Normal practice based on the treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will be done before enrollment. Patients will be monitored for all the efficacy and safety endpoints during the treatment period. HCV RNA will be checked at time of transplant. Finally, patients will received regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after liver transplantation.
Detailed description
End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver transplantation.(Bzowej et al., 2011)
Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease patients awaiting for liver transplantation annually. If the HCV viral load can be significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy with pegylated interferon alfa (PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al, 2011).
We aim to conduct a prospective, open label, single arm study. This study design is single arm to treat HCV patients with pegylated interferon alfa (PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapies before liver transplantation for patients with detectable HCV RNA. The total number of patients would be around 20 cases included in the study and all of them will take pegylated interferon alfa (PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin, followed by Boceprevir + Peg-Interferon α-2b + Ribavirin for at least 16 weeks or maximal 44 weeks before transplantation. The treatment will be discontinued immediately at time of liver transplantation. Normal practice based on the treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will be done before enrollment.
-Treatment Stopping Rules-
If the patient has HCV RNA >100 IU/ml at week 12 after the beginning of treatment with peg interferon plus ribavirin, i.e. 8 weeks after the initiation of therapy with boceprevir, all HCV medications are to be discontinued.
If the patient has detectable HCV RNA at Week 24 after the beginning of treatment with peg interferon plus ribavirin, i.e. 20 weeks after the initiation of therapy with boceprevir, all HCV medications are to be discontinued.
Monitoring of Patients during Treatment Complete blood counts should be obtained pretreatment, Treatment Week 4, Treatment Week 8, and thereafter, as clinically appropriate. If serum hemoglobin is <10 g/dL, a decrease in dosage of ribavirin and/or administration with erythropoietin (epoetin alfa) may be warranted.
-Primary Outcome Measure: Title: Number of Participants with Adverse Events as a Measure of Safety Time Frame: Up to the time of liver transplant
-Secondary Outcome Measures: Title: HCV-RNA (Hepatitis C virus RNA) level Time Frame: Baseline, Treatment Week 12 , Treatment Week 24. A follow-up test is recommended 24 weeks after the completion of treatment, or at time of liver transplant. Finally, patients will receive regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boc+Peg-int alfa+Rbv | Experimental | Drug: Boceprevir 800mg/TID+Pegylated interferon alfa+RibavirinBoceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult 20 years and older
- Chronic infection with genotype 1 hepatitis C virus proven with positive PCR
- Liver cirrhosis while awaiting liver transplantation
- Patient with compensated liver functions
- With or without hepatocellular carcinoma.
Key exclusion criteria (16 listed)
- Non controlled sepsis
- Platelets < 50,000/mm3
- Neutrophil granulocyte levels < 1000/mm3
- Creatinine clearance < 50 mL/min
- Hb < 10 g/dL
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 800mg/TID+Pegylated interferon alfa+RibavirinAlso: Victrelis (Boceprevir)Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin | Drug | Boc+Peg-int alfa+Rbv |
Primary outcome
Number of Participants with Adverse Events
Time frame: within 1 year
1 secondary outcome
HCV-RNA (Hepatitis C virus RNA) level
Time frame: within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
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.
Tsung-Hui Hu, Ph.D principal investigator
Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin in people with Late Complication From Liver Transplant, run by Hu Tsung-Hui at 1 site in Taiwan.
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 12 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Jun 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 Taiwan. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsung-Hui Hu, Ph.D (+886 7 731 7123 ext. 8301, dr.hu@msa.hinet.net; hutsh@ms32.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: within 1 year). 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 Jun 2014.