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Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

Primary Purpose

Hepatitis C Virus Infection

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LDV/SOF

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring renal transplant

Eligibility Criteria

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

Key Inclusion Criteria:

Genotype 1 or 4 chronic HCV infection
Have received a kidney transplant more than 6 months before the Baseline visit
Cirrhosis determination
Screening laboratory parameters within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain -resolved skin cancers)
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Planned or anticipated second kidney transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

LDV/SOF 12 wk

LDV/SOF 24 wk

Arm Description

Participants will receive LDV/SOF FDC for 12 weeks.

Participants will receive LDV/SOF FDC for 24 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Percentage of Participants With Virologic Failure

Virologic failure was defined as: On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Full Information

NCT ID

NCT02251717

First Posted

September 25, 2014

Last Updated

October 19, 2018

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02251717

Brief Title

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

Official Title

A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 14, 2014 (Actual)

Primary Completion Date

March 24, 2016 (Actual)

Study Completion Date

June 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

6. Conditions and Keywords

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

Hepatitis C Virus Infection

Keywords

renal transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF 12 wk

Arm Type

Experimental

Arm Description

Participants will receive LDV/SOF FDC for 12 weeks.

Arm Title

LDV/SOF 24 wk

Arm Type

Experimental

Arm Description

Participants will receive LDV/SOF FDC for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

90/400 mg FDC tablet administered orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Description

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Time Frame

Posttreatment Week 12

Title

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time Frame

Up to 24 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

Description

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time Frame

Posttreatment Weeks 4 and 24

Title

Percentage of Participants With Virologic Failure

Description

Time Frame

Up to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Genotype 1 or 4 chronic HCV infection Have received a kidney transplant more than 6 months before the Baseline visit Cirrhosis determination Screening laboratory parameters within defined thresholds Use of two effective contraception methods if female of childbearing potential or sexually active male Key Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain -resolved skin cancers) History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol Planned or anticipated second kidney transplant Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

City

Wien

Country

Austria

City

Marseille

Country

France

City

Paris

Country

France

City

Hannover

Country

Germany

City

Milan

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing URL

http://www.gilead.com/research/disclosure-and-transparency

Citations:

Citation

Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation).

Results Reference

result

PubMed Identifier

27842383

Citation

Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.

Results Reference

result

Learn more about this trial

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

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