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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF | Experimental | Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally once daily without regard to food |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants Experiencing Viral Breakthrough |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100015 | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 27198664 | Result | 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. | |
| 26841930 |
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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.
18 months after study completion
A secured external environment with username, password, and RSA code.
416 participants were screened.
Participants were enrolled at study sites in Mainland China (referred to as China throughout this results record), Korea, and Taiwan. The first participant was screened on 10 December 2013. The last study visit occurred on 29 September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF (Overall) | Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily administered without regard to food for 12 weeks in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | May 28, 2013 | Jun 21, 2018 |
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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). |
| Up to 12 weeks |
| 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. | Week 12 to Posttreatment Week 24 |
| HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only | Baseline; Week 12 |
| Beijing |
| 100034 |
| China |
| Beijing | 100044 | China |
| Beijing | 100050 | China |
| Beijing | 100069 | China |
| Chongqing | 400010 | China |
| Guangdong | 510515 | China |
| Guangxi | 530021 | China |
| Hubei | 430030 | China |
| Hunan | 410011 | China |
| Jiangxi | 210029 | China |
| Jiangxi | 330006 | China |
| Jilin City | 130021 | China |
| Shandong | 250021 | China |
| Shanghai | 200025 | China |
| Shanghai | 200083 | China |
| Shijiazhuang | 050051 | China |
| Sichuan | 610041 | China |
| Ansan-si | Gyeonggi-do | 425-707 | South Korea |
| Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
| Incheon | Gyeonggi-do | 405-760 | South Korea |
| Seongnam-si | Gyeonggi-do | 467-707 | South Korea |
| Busan | 602-715 | South Korea |
| Busan | 602-739 | South Korea |
| Busan | 614-735 | South Korea |
| Daegu | 700-721 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-720 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | 152-703 | South Korea |
| Seoul | 735-710 | South Korea |
| Changhua | 50006 | Taiwan |
| Kaohsiung City | 80708 | Taiwan |
| Kaohsiung City | 82445 | Taiwan |
| Kaohsiung City | 83301 | Taiwan |
| Keelung | 20401 | Taiwan |
| Taichung | 40447 | Taiwan |
| Tainan | 70457 | Taiwan |
| Tainan | 73657 | Taiwan |
| Taipei | 10048 | Taiwan |
| Taipei | 10449 | Taiwan |
| Taipei | 11217 | Taiwan |
| Taoyuan | 33305 | Taiwan |
| Result |
| 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. |
| Result | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who were enrolled and received at least 1 dose of study
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF | LDV/SOF (90/400 mg) FDC tablet administered once daily without regard to food for 12 weeks in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| IL28B | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set: participants who were enrolled and received at least 1 dose of study drug, and have chronic genotype 1 HCV infection. | Posted | Number | 95% Confidence Interval | Percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
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| Secondary | 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). | Full Analysis Set | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | 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. | Full Analysis Set | Posted | Number | percentage of participants | Week 12 to Posttreatment Week 24 |
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| Secondary | HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only | Only Chinese participants in the Full Analysis set were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 12 |
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Up to 12 weeks plus 30 days
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDV/SOF (Overall) | LDV/SOF (90/400 mg) FDC tablet administered once daily without regard to food for 12 weeks in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan | 0 | 384 | 7 | 384 | 105 | 384 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Bone contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Adenomyosis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Aug 1, 2014 | Jun 21, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Feb 12, 2016 | Jun 21, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2017 | Jun 21, 2018 | SAP_003.pdf |
| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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| Taiwanese |
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| Other (Taiwanese- Chinese) |
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| Taiwan |
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| TT |
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| Title | Denominators | Categories |
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| Baseline |
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| Change at Week 12 |
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