Back to resultsLedipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LDV/SOF
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring 7977, 5885, GS-7977, GS-5885, SOF, LDV, Sofosbuvir, Ledipasvir, FDC
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) greater than or equal to 18 kg/m^2.
- HCV RNA greater than or equal to 1000 IU/mL at screening.
- Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
- Screening laboratory values within predefined thresholds.
- Use of two effective contraception methods if female of childbearing potential or sexually active male.
- Healthy according to medical history and physical examination with the exception of HCV diagnosis.
Exclusion Criteria:
- Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
- Prior exposure to an HCV NS5a inhibitor.
- Pregnant or nursing female.
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- History of solid organ transplantation.
- Current or prior history of clinical hepatic decompensation.
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- Known hypersensitivity to LDV, SOF, or formulation excipients.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LDV/SOF
Arm Description
Participants will receive LDV/SOF FDC for 12 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ on Treatment
HCV RNA Change From Baseline
Percentage of Participants Experiencing 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
1. Study Identification
Unique Protocol Identification Number
NCT01924949
Brief Title
Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
Official Title
An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
7977, 5885, GS-7977, GS-5885, SOF, LDV, Sofosbuvir, Ledipasvir, FDC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LDV/SOF
Arm Type
Experimental
Arm Description
Participants will receive LDV/SOF FDC for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
Harvoni®, GS-5885/GS-7977
Intervention Description
Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 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 HCV RNA < LLOQ on Treatment
Time Frame
Up to 12 weeks
Title
HCV RNA Change From Baseline
Time Frame
Baseline; Weeks 1, 4, and 8
Title
Percentage of Participants Experiencing Virologic Failure
Description
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.
Time Frame
Baseline to posttreatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) greater than or equal to 18 kg/m^2.
HCV RNA greater than or equal to 1000 IU/mL at screening.
Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
Screening laboratory values within predefined thresholds.
Use of two effective contraception methods if female of childbearing potential or sexually active male.
Healthy according to medical history and physical examination with the exception of HCV diagnosis.
Exclusion Criteria:
Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
Prior exposure to an HCV NS5a inhibitor.
Pregnant or nursing female.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
History of solid organ transplantation.
Current or prior history of clinical hepatic decompensation.
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
Known hypersensitivity to LDV, SOF, or formulation excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luisa Stamm, MD, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Boston
State/Province
Massachusetts
Country
United States
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
Learn more about this trial
Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
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