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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

Primary Purpose

Chronic HCV Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LDV/SOF
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

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

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
  • Genotype 1 HCV at screening
  • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Key Exclusion Criteria:

  • Pregnant or nursing female
  • Chronic liver disease of a non-HCV etiology
  • Current or prior history of any clinically-significant illness (other than HCV)
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDV/SOF

Arm Description

Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued 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 SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only

Full Information

First Posted
December 20, 2013
Last Updated
February 18, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02021656
Brief Title
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
Official Title
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 10, 2013 (Actual)
Primary Completion Date
July 8, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic 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
Chronic HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDV/SOF
Arm Type
Experimental
Arm Description
Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 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 without regard to food
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued 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 SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants Experiencing Viral Breakthrough
Description
Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).
Time Frame
Up to 12 weeks
Title
Percentage of Participants Experiencing Viral Relapse
Description
Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
Time Frame
Week 12 to Posttreatment Week 24
Title
HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
Time Frame
Baseline; Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to provide written informed consent HCV RNA ≥ 10^4 IU/mL at screening HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse. Genotype 1 HCV at screening HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy Key Exclusion Criteria: Pregnant or nursing female Chronic liver disease of a non-HCV etiology Current or prior history of any clinically-significant illness (other than HCV) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 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
Beijing
ZIP/Postal Code
100015
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100069
Country
China
City
Chongqing
ZIP/Postal Code
400010
Country
China
City
Guangdong
ZIP/Postal Code
510515
Country
China
City
Guangxi
ZIP/Postal Code
530021
Country
China
City
Hubei
ZIP/Postal Code
430030
Country
China
City
Hunan
ZIP/Postal Code
410011
Country
China
City
Jiangxi
ZIP/Postal Code
210029
Country
China
City
Jiangxi
ZIP/Postal Code
330006
Country
China
City
Jilin
ZIP/Postal Code
130021
Country
China
City
Shandong
ZIP/Postal Code
250021
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200083
Country
China
City
Shijiazhuang
ZIP/Postal Code
050051
Country
China
City
Sichuan
ZIP/Postal Code
610041
Country
China
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
City
Incheon
State/Province
Gyeonggi-do
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
467-707
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
735-710
Country
Korea, Republic of
City
Changhua City
ZIP/Postal Code
50006
Country
Taiwan
City
Kaohsiung City
ZIP/Postal Code
80708
Country
Taiwan
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
City
Tainan City
ZIP/Postal Code
70457
Country
Taiwan
City
Tainan city
ZIP/Postal Code
73657
Country
Taiwan
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
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
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
Citation
Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial. Poster No. 1191, AASLD 2017.
Results Reference
result
PubMed Identifier
27198664
Citation
Lim YS, Ahn SH, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Garrison KL, Gao B, Knox SJ, Pang PS, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatol Int. 2016 Nov;10(6):947-955. doi: 10.1007/s12072-016-9726-5. Epub 2016 May 20.
Results Reference
result
PubMed Identifier
26841930
Citation
Chuang WL, Chien RN, Peng CY, Chang TT, Lo GH, Sheen IS, Wang HY, Chen JJ, Yang JC, Knox SJ, Gao B, Garrison KL, Mo H, Pang PS, Hsu YC, Hu TH, Chu CJ, Kao JH. Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus. J Gastroenterol Hepatol. 2016 Jul;31(7):1323-9. doi: 10.1111/jgh.13305.
Results Reference
result
Citation
Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial., [Abstract 1191]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.
Results Reference
result

Learn more about this trial

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

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