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Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Primary Purpose

Chronic HCV Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LDV/SOF
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic HCV Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Able to provide written informed consent
  • Chronic genotype 1 and/or 4 HCV infection
  • Normal ECG
  • Negative serum pregnancy test for female subjects
  • Male subjects and female subjects of childbearing potential must agree to use contraception
  • Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion Criteria:

  • Serious or active medical or psychiatric illness
  • HIV or hepatitis B viral (HBV) infection
  • Stomach disorder that could interfere with the absorption of the study drug
  • Treated with an anti-HCV medication in the last 30 days
  • Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
  • Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
  • History of clinically significant medical condition associated with other chronic liver disease
  • Active spontaneous bacterial peritonitis at screening
  • Females who are breastfeeding
  • Infection requiring systemic antibiotics
  • Participated in a clinical study with an investigational drug or biologic within the last 30 days
  • Active or history (last 6 months) of drug or alcohol abuse
  • History of organ transplant other than liver, kidney, or corneal.

Sites / Locations

  • Royal Prince Alfred Hospital, University of Sydney
  • Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre
  • Medizinische Universitaet Innsbruck
  • Medizinische Universitat Wien
  • UCL St-Luc Brussels
  • Universitair Ziekenhuis Gent
  • Division of Gastroenterology, University of Alberta, Edmonton
  • University of British Columbia and Vancouver General Hospital
  • London Health Sciences Centre-University Hospital
  • University Health Network // Toronto General Hospital
  • Hopital St. Luc
  • McGill University Health Centre \\ Royal Victoria Hospital
  • Hospital Beaujon
  • Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,
  • Hopital Saint-Eloi
  • Hopital Paul Brousse
  • Universitätsklinikum RWTH Aachen
  • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie
  • University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I
  • Medical School of Hannover
  • IRCCS Cà Grande Ospedale Maggiore Policlinico
  • Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino
  • Leids Universitair Medisch Centrum
  • Erasmus MC in Rotterdam
  • Auckland City Hospital
  • Hospital General Universitari Vall d' Hebron
  • Hospital Clinic i Provincial
  • Puerta de Hierro, Madrid
  • Hospital Universitario y Politecnico La Fe de Valencia
  • University of Berne
  • University Hospital Zurich
  • University Hospitals Birmingham NHS Foundation Trust
  • Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh
  • Kings College Hospital, Institute of Liver Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A, Group 1 (12 wk): CPT Class B (7-9)

Cohort A, Group 1 (24 wk): CPT Class B (7-9)

Cohort A, Group 2 (12 wk): CPT Class C (10-12)

Cohort A, Group 2 (24 wk): CPT Class C (10-12)

Cohort B, Group 3 (12 wk): F0-F3 Fibrosis

Cohort B, Group 3 (24 wk): F0-F3 Fibrosis

Cohort B, Group 4 (12 wk): CPT Class A (5-6)

Cohort B, Group 4 (24 wk): CPT Class A (5-6)

Cohort B, Group 5 (12 wk): CPT Class B (7-9)

Cohort B, Group 5 (24 wk): CPT Class B (7-9)

Cohort B, Group 6 (12 wk): CPT Class C (10-12)

Cohort B, Group 6 (24 wk): CPT Class C (10-12)

Cohort B, Group 7 (12 wk): FCH

Cohort B, Group 7 (24 wk): FCH

Arm Description

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)

LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3

LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3

LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)

LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)

LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)

LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH

LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH

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 Discontinued Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
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 on 2 consecutive measurements while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.
Percentage of Participants With HCV RNA < LLOQ at Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24
HCV RNA Levels and Change From Baseline at Week 1
HCV RNA Levels and Change From Baseline at Week 2
HCV RNA Levels and Change From Baseline at Week 4
HCV RNA Levels and Change From Baseline at Week 6
HCV RNA Levels and Change From Baseline at Week 8
HCV RNA Levels and Change From Baseline at Week 12
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.

Full Information

First Posted
December 9, 2013
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02010255
Brief Title
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
Official Title
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; Cohort B: post-liver transplant, with or without cirrhosis; Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Arm Title
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Arm Title
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Arm Title
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Arm Title
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
Arm Title
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Arm Title
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
Arm Title
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
Arm Title
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Arm Title
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Arm Title
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Arm Title
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Arm Title
Cohort B, Group 7 (12 wk): FCH
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
Arm Title
Cohort B, Group 7 (24 wk): FCH
Arm Type
Experimental
Arm Description
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
Harvoni®, GS-5885/GS-7977
Intervention Description
LDV/SOF FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
RBV tablets administered orally in a divided daily dose
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 Discontinued Study Drug Due to an Adverse Event
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
Description
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.
Time Frame
Posttreatment Week 2
Title
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
Description
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.
Time Frame
Posttreatment Week 8
Title
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
Description
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame
Posttreatment Week 24
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as: On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame
Up to Posttreatment Week 24
Title
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
Description
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time Frame
Week 1
Title
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time Frame
Week 2
Title
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time Frame
Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at Week 6
Time Frame
Week 6
Title
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time Frame
Week 8
Title
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time Frame
Week 12
Title
Percentage of Participants With HCV RNA < LLOQ at Week 16
Time Frame
Week 16
Title
Percentage of Participants With HCV RNA < LLOQ at Week 20
Time Frame
Week 20
Title
Percentage of Participants With HCV RNA < LLOQ at Week 24
Time Frame
Week 24
Title
HCV RNA Levels and Change From Baseline at Week 1
Time Frame
Baseline; Week 1
Title
HCV RNA Levels and Change From Baseline at Week 2
Time Frame
Baseline; Week 2
Title
HCV RNA Levels and Change From Baseline at Week 4
Time Frame
Baseline; Week 4
Title
HCV RNA Levels and Change From Baseline at Week 6
Time Frame
Baseline; Week 6
Title
HCV RNA Levels and Change From Baseline at Week 8
Time Frame
Baseline; Week 8
Title
HCV RNA Levels and Change From Baseline at Week 12
Time Frame
Baseline; Week 12
Title
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Description
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Time Frame
Baseline to Posttreatment Week 4
Title
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
Description
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
Time Frame
Baseline to Posttreatment Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent Chronic genotype 1 and/or 4 HCV infection Normal ECG Negative serum pregnancy test for female subjects Male subjects and female subjects of childbearing potential must agree to use contraception Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits Exclusion Criteria: Serious or active medical or psychiatric illness HIV or hepatitis B viral (HBV) infection Stomach disorder that could interfere with the absorption of the study drug Treated with an anti-HCV medication in the last 30 days Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening History of clinically significant medical condition associated with other chronic liver disease Active spontaneous bacterial peritonitis at screening Females who are breastfeeding Infection requiring systemic antibiotics Participated in a clinical study with an investigational drug or biologic within the last 30 days Active or history (last 6 months) of drug or alcohol abuse History of organ transplant other than liver, kidney, or corneal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shampa De-Oertel, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Royal Prince Alfred Hospital, University of Sydney
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Medizinische Universitat Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UCL St-Luc Brussels
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Division of Gastroenterology, University of Alberta, Edmonton
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C2
Country
Canada
Facility Name
University of British Columbia and Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3P1
Country
Canada
Facility Name
London Health Sciences Centre-University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University Health Network // Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Hopital St. Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Health Centre \\ Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Hospital Beaujon
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif Cedex
ZIP/Postal Code
94804
Country
France
Facility Name
Universitätsklinikum RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medical School of Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
IRCCS Cà Grande Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus MC in Rotterdam
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Hospital General Universitari Vall d' Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Puerta de Hierro, Madrid
City
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe de Valencia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
University of Berne
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh
City
Edinburgh
ZIP/Postal Code
EH3 9YW
Country
United Kingdom
Facility Name
Kings College Hospital, Institute of Liver Studies
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

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:
PubMed Identifier
26907736
Citation
Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Mullhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18. Erratum In: Lancet Infect Dis. 2016 Jun;16(6):636.
Results Reference
derived

Learn more about this trial

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

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