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LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sofosbuvir/Ledipasvir x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

At least 18 years of age and able to give informed consent
History of HCV genotype 1 or 4
Normal EKG
At least 91 days post orthotopic liver transplant
Screening laboratory values within defined thresholds
Detectable HCV RNA at screening
Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation
Negative pregnancy test for female subjects within 48 hours prior to receiving study medication
Use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy

Exclusion Criteria

Serious or active medical or psychiatric illness
History of significant or unstable cardiac disease
Stomach disorder that could interfere with the absorption of the study drug
Pregnant or nursing females or males with a pregnant female partner
Co-infected with Hepatits B (HBV) or HIV
Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant
Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
History of exposure to an Nonstructural protein (NS5A) inhibitor
Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant
Participated in a clinical study with an investigational drug or biologic within the last 30 days
Combined liver/kidney transplant
History of organ transplant other than liver
Childs Turcotte Pugh (CTP) B or C
Patients with fibrosing cholestatic hepatitis
Platelet count of ≤ 30 k/mm3
Hemoglobin < 10g/dL
Total bilirubin > 10mg/dL
Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
Serum sodium < 125mmol/L
Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening

Sites / Locations

Medstar Georgetown University Hospital
University Hospitals Cleveland Medical Center
University of Pittsburgh Medical Center
Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Late Cohort, Arm 1

Late Cohort, Arm 2

Arm Description

Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks

Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks

Outcomes

Primary Outcome Measures

Treatment Efficacy

Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen

Secondary Outcome Measures

Number of Participants With Virologic Failure

Number of participants who had a nonresponse to treatment or a relapse of disease under study.

Hemoglobin Levels

Change in hemoglobin levels over the course of the study

Full Information

NCT ID

NCT02631772

First Posted

December 14, 2015

Last Updated

April 12, 2019

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT02631772

Brief Title

LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Official Title

LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 1, 2016 (Actual)

Primary Completion Date

May 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

Detailed Description

This is a multicenter, prospective, randomized, open-label phase IV study. Compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Late Cohort, Arm 1

Arm Type

Experimental

Arm Description

Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks

Arm Title

Late Cohort, Arm 2

Arm Type

Active Comparator

Arm Description

Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir/Ledipasvir x 12 weeks

Other Intervention Name(s)

Harvoni

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Primary Outcome Measure Information:

Title

Treatment Efficacy

Description

Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Virologic Failure

Description

Number of participants who had a nonresponse to treatment or a relapse of disease under study.

Time Frame

12 weeks

Title

Hemoglobin Levels

Description

Change in hemoglobin levels over the course of the study

Time Frame

Week 4, Week 8, Week 12, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria At least 18 years of age and able to give informed consent History of HCV genotype 1 or 4 Normal EKG At least 91 days post orthotopic liver transplant Screening laboratory values within defined thresholds Detectable HCV RNA at screening Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation Negative pregnancy test for female subjects within 48 hours prior to receiving study medication Use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy Exclusion Criteria Serious or active medical or psychiatric illness History of significant or unstable cardiac disease Stomach disorder that could interfere with the absorption of the study drug Pregnant or nursing females or males with a pregnant female partner Co-infected with Hepatits B (HBV) or HIV Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin History of exposure to an Nonstructural protein (NS5A) inhibitor Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant Participated in a clinical study with an investigational drug or biologic within the last 30 days Combined liver/kidney transplant History of organ transplant other than liver Childs Turcotte Pugh (CTP) B or C Patients with fibrosing cholestatic hepatitis Platelet count of ≤ 30 k/mm3 Hemoglobin < 10g/dL Total bilirubin > 10mg/dL Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal Serum sodium < 125mmol/L Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening

Facility Information:

Facility Name

Medstar Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

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