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Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients. (EGRADICATE)

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ClinicalTrials.gov Identifier: NCT02890719
Recruitment Status : Withdrawn (impossibility of supplying the medication in research of the study by the pharmaceutical company that gave it to the trial)
First Posted : September 7, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Brief Summary:
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.

Condition or disease Intervention/treatment Phase
Liver Transplantation Hepatitis C Drug: Grazoprevir 100 mg/day Drug: Elbasvir 50 mg/d Drug: Elbasvir 50 mg/day Drug: Ribavirin 1200 mg/day Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Genotype 1B
treatment 12 weeks
Drug: Grazoprevir 100 mg/day
Grazoprevir 100 mg/ day 12 weeks
Other Name: J05AX68 100 mg

Drug: Elbasvir 50 mg/d
Elbasvir 50 mg/day 12 weeks
Other Name: J05AX68 50mg

Experimental: Genotype 1A and 4
treatment 16 weeks
Drug: Grazoprevir 100 mg/day
Grazoprevir 100 mg/day 16 weeks
Other Name: J05AX68 100 mg

Drug: Elbasvir 50 mg/day
Elbasvir 50 mg/d 16 weeks
Other Name: 50mg J05AX68

Drug: Ribavirin 1200 mg/day
Ribavirin 1200 mg/day 16 weeks
Other Name: J05AB04 1200 mg/d




Primary Outcome Measures :
  1. Sustained virological response [ Time Frame: 12 weeks post-treatment ]
    Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.


Secondary Outcome Measures :
  1. Sustained virological response [ Time Frame: 4 weeks and 24 weeks post-treatment ]
    Sustained virological response 12 ( SVR12) defined as HCV-RNA undetectable at post-treatment weeks 4 and , 24 respectively.

  2. To evaluate the beneficial effects of antiviral therapy on renal function. [ Time Frame: 24 weeks post-treatment ]
    creatinine sample analyses blood analyses in all visits

  3. To assess the impact of therapy in kidney function. [ Time Frame: 24 weeks post-treatment ]
    Elevation Transaminases blood analyses in all visits

  4. Tolerability of this combination in liver transplant recipients. [ Time Frame: Every visit ]
    Serious advers events evaluation



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 78 year-old.
  • Previous liver transplantation(more than 6 month).
  • Genotype 1 and 4 infection.
  • Hepatitis C recurrence defined by the presence of abnormal liver function test, positive HCV-RNA, histological signs of hepatitis C recurrence.
  • Viral load ≥10000UI/mL.
  • Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, ≤10 mg/d).
  • Treatment naïve or treatment experienced (Peg-RBV or triple therapy).

Exclusion Criteria:

  • Genotype 2, 3, 5 or 6 infection.
  • Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
  • Hepatocellular carcinoma after liver transplantation.
  • Total bilirubin > 3 mg/dL.
  • Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
  • Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes.
  • Platelets < 75 x 109 cells/L.
  • Neutrophil count < 0.5 x 109 cells/L.
  • Hemoglobin < 9 g/dL.
  • Albumin < 3g/dL.
  • HIV infection.
  • Hepatitis B infection.
  • Active intake of toxic amounts of alcohol or recreational drugs.
  • Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding.
  • Intake of disallowed medications including(but not limited to):

    1. Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
    2. Antifungals: itraconazole, ketoconazole, voriconazole
    3. Antihypertensives: nifedipine
    4. Anticonvulsants: carbamazepine, phenytoin, phenobarbital
    5. Bosentan
    6. Modafinil
    7. St.Jonh's Wort
    8. Immunosuppressants: cyclosporin, everolimus, sirolimus
    9. Diabetes agents: glibenclamide, glyburide
    10. Lipid lowering agents: gemfibrozil
    11. Eltrombopag
    12. Lapatinib
    13. HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
    14. Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.

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Responsible Party: Anna Cruceta, Xavier Forns, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02890719     History of Changes
Other Study ID Numbers: EGRADICATE
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents