Clinical trial NCT02021656: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic HCV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 384
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants Experiencing Viral Breakthrough
timeFrame: Up to 12 weeks
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Week 12 to Posttreatment Week 24
measure: HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Guangdong
country: China
city: Guangxi
country: China
city: Hubei
country: China
city: Hunan
country: China
city: Jiangxi
country: China
city: Jiangxi
country: China
city: Jilin
country: China
city: Shandong
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shijiazhuang
country: China
city: Sichuan
country: China
city: Ansan-si
country: Korea, Republic of
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Changhua City
country: Taiwan
city: Kaohsiung City
country: Taiwan
city: Kaohsiung City
country: Taiwan
city: Kaohsiung City
country: Taiwan
city: Keelung
country: Taiwan
city: Taichung City
country: Taiwan
city: Tainan City
country: Taiwan
city: Tainan city
country: Taiwan
city: Taipei City
country: Taiwan
city: Taipei City
country: Taiwan
city: Taipei City
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.