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An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation (REPLACE)

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: NCT01571583
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Tracking Information
First Submitted Date  ICMJE December 16, 2011
First Posted Date  ICMJE April 5, 2012
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
Number of patients achieving sustained virologic response (SVR) 12 planned [ Time Frame: Week 60 ]
SVR12 planned is defined as having plasma hepatitis C virus (HCV ) ribonucleic acid (RNA) level less than 25 IU/mL 12 weeks after the last planned dose of study medication.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels. [ Time Frame: Up to week 72 ]
Change History Complete list of historical versions of study NCT01571583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • Number of patients achieving SVR12 planned(c) [ Time Frame: Week 60 ]
    SVR12 planned(c) is defined as having undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study drugs.
  • Number of patients achieving SVR24 planned [ Time Frame: Week 72 ]
    SVR24 planned is defined as having plasma HCV RNA levels less than 25 IU/mL 24 weeks after the last planned dose of study medication.
  • Number of patients achieving SVR24 planned(c) [ Time Frame: Week 72 ]
    SVR24 planned(c) is defined as having an undetectable plasma HCV RNA level 24 weeks after the last planned dose of study medication.
  • Number of patients having an undetectable HCV RNA level at Week 4 of treatment [ Time Frame: Week 4 ]
  • Number of patients having an undetectable HCV RNA level at Week 12 of treatment [ Time Frame: Week 12 ]
  • Number of patients having undetectable HCV RNA levels at Week 4 and Week 12 of treatment [ Time Frame: Week 4 and Week 12 ]
  • Number of patients having an undetectable HCV RNA level at the actual end of treatment [ Time Frame: Week 48 ]
  • Number of patients having an undetectable HCV RNA level at the planned end of treatment [ Time Frame: Week 48 ]
  • Number of patients having less than 25 IU/mL at the planned end of treatment [ Time Frame: Week 48 ]
  • Number of patients with on-treatment virologic failure [ Time Frame: Week 48 ]
    Virologic failure is defined as patients who meet a virologic stopping rule and/or meet the definition of viral breakthrough.
  • Number of patients with relapse after undetectable HCV RNA at actual end of treatment [ Time Frame: Week 48 ]
    Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (less than 25 IU/mL, target not detected) at actual end of treatment.
  • Number of patients with relapse after undetectable HCV RNA at planned end of treatment [ Time Frame: Week 48 ]
    Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (less than 25 IU/mL, target not detected) at planned end of treatment.
  • Number of patients with relapse after previous HCV RNA less than 25 IU/mL at planned end of treatment [ Time Frame: Week 48 ]
    Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
  • Number of patients with viral breakthrough [ Time Frame: Week 48 ]
    Number of patients with viral breakthrough (defined as an increase more than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA more than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
  • Change from baseline in log HCV RNA values [ Time Frame: Up to Week 52 ]
    Change from baseline in log HCV RNA values at each time point during treatment.
  • Number of patients who have changes in liver graft biopsy histology [ Time Frame: Up to Week 72 ]
  • Number of patients with adverse events [ Time Frame: Up to Week 72 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
  • Proportion of patients having detectable plasma HCV ribonucleic acid (RNA levels) of <25IU/mL [ Time Frame: Up to week 72 ]
  • Proportion of patients having confirmed detectable HCV ribonucleic acid (RNA levels) [ Time Frame: Up to week 72 ]
  • Proportion of patients having an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA has previously become < 25 IU/mL during treatment [ Time Frame: Up to week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation
Official Title  ICMJE Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
Brief Summary The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.
Detailed Description This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Virus (HCV) Infection
Intervention  ICMJE
  • Drug: Telaprevir
    Type=exact number, unit=mg, number=375, form=tablet, route=oral. Patients will receive 2 oral tablets (750 mg) every 8 hours for 12 weeks.
  • Drug: Pegylated interferon alfa-2a
    Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.
  • Drug: Ribavirin
    Type=exact number, unit=mg, number=200, form=tablet, route=oral. Starting from 600 mg (3 tablets) per day on Day 1. This dose will become higher or lower based on blood results and the investigators opinion (to a goal of 1000 to 1200 mg/day [5 to 6 tablets] based on subject weight), twice daily regimen, for 48 weeks.
Study Arms  ICMJE Experimental: Telaprevir+Peg-IFN-alfa-2a+Ribavirin
Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone.
Interventions:
  • Drug: Telaprevir
  • Drug: Pegylated interferon alfa-2a
  • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2013)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2012)
72
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
  • More than 6 months to 10 years post-liver transplant
  • Patient did or did not receive treatment for HCV prior to liver transplantation
  • Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
  • A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin

Exclusion Criteria:

  • Patient is currently infected or co-infected with HCV of another genotype than genotype 1
  • Patient received treatment for hepatitis C following liver transplantation
  • Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Patient with human immunodeficiency virus or hepatitis B virus co-infection
  • Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01571583
Other Study ID Numbers  ICMJE CR018721
VX-950HPC3006 ( Other Identifier: Janssen-Cilag International NV, Belgium )
2011-004724-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen-Cilag International NV
Study Sponsor  ICMJE Janssen-Cilag International NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag International NV, Belgium Clinical Trial Janssen-Cilag International NV
PRS Account Janssen-Cilag International NV
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP