Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Boceprevir Treatment in Liver Pre-transplant HCV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160080
Recruitment Status : Unknown
Verified June 2014 by Hu Tsung-Hui, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Hu Tsung-Hui, Chang Gung Memorial Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Late Complication From Liver Transplant Drug: Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Boceprevir Treatment in Liver Pre-transplant HCV Patients
Study Start Date : January 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Boc+Peg-int alfa+Rbv
Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
Drug: Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
Other Name: Victrelis (Boceprevir)




Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: within 1 year ]

Secondary Outcome Measures :
  1. HCV-RNA (Hepatitis C virus RNA) level [ Time Frame: within 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult 20 years and older
  2. Chronic infection with genotype 1 hepatitis C virus proven with positive PCR
  3. Liver cirrhosis while awaiting liver transplantation
  4. Patient with compensated liver functions
  5. With or without hepatocellular carcinoma.
  6. Naive or experienced (failure) to HCV antiviral treatmentFailure is defined according to the following terminology:

    • 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
  7. No need for prior treatment wash-out
  8. Written patient informed consent

Exclusion Criteria:

  1. Non controlled sepsis
  2. Platelets < 50,000/mm3
  3. Neutrophil granulocyte levels < 1000/mm3
  4. Creatinine clearance < 50 mL/min
  5. Hb < 10 g/dL
  6. Uncontrolled psychiatric problems
  7. Hypersensitivity or contraindications to any component of boceprevir formulation
  8. Contraindication to interferon or ribavirin
  9. HIV coinfection
  10. HBV coinfection (unless this is treated effectively with analogues, as proven by undetectable viremia for at least 12 months)
  11. Other infectious disease underway
  12. Neoplastic disease other than hepatocellular carcinoma during the previous year, or neoplastic disease for which the prognosis is less than 3 years
  13. Treatment with immunosuppressors (including corticosteroids), antivirals other than those for the study, except aciclovir
  14. Current or anticipated use of any of the following prohibited medications: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives
  15. Person participating in another study including an exclusion period that is still underway during pre-enrollment
  16. Pregnancy, breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160080


Contacts
Layout table for location contacts
Contact: Tsung-Hui Hu, Ph.D +886 7 731 7123 ext 8301 dr.hu@msa.hinet.net; hutsh@ms32.hinet.net
Contact: Yu-Jean Chen +886 7 731 7123 ext 2446 beaglelulu@yahoo.com.tw

Locations
Layout table for location information
Taiwan
123, Ta Pei Road, Niao Sung Hsiang Recruiting
Kaohsiung Hsien, Taiwan, 833
Contact: Tsung-Hui Hu, Ph.D    +886 7 7317123 ext 8301    dr.hu@msa.hinet.net   
Contact: Yu-Jean Chen, M's    +886 7 7317123 ext 2446    beaglelulu@yahoo.com.tw   
Principal Investigator: Tsung-Hui Hu, Ph.D         
Sponsors and Collaborators
Hu Tsung-Hui
Investigators
Layout table for investigator information
Principal Investigator: Tsung-Hui Hu, Ph.D Department of Internal Medicine
Layout table for additonal information
Responsible Party: Hu Tsung-Hui, Tsung-Hui Hu MD.PhD, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02160080    
Other Study ID Numbers: IRB:102-4331A
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014
Keywords provided by Hu Tsung-Hui, Chang Gung Memorial Hospital:
Boceprevir;
Liver pre-transplant
Additional relevant MeSH terms:
Layout table for MeSH terms
Interferons
Ribavirin
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs