Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF (treatment naive) | Experimental | Treatment-naive participants will receive LDV/SOF for 12 weeks. |
|
| LDV/SOF+RBV (treatment naive) | Experimental | Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks. |
|
| LDV/SOF (treatment experienced) | Experimental | Treatment-experienced participants will receive LDV/SOF for 12 weeks. |
|
| LDV/SOF+RBV (treatment experienced) | Experimental | Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | LDV/SOF 90/400 mg FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants With Sustained Virologic Response 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. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any 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 SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants Experiencing Virologic Failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Knox | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichikawa | Chiba | 272-8516 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25863559 | Derived | Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H, Nakane K, Enomoto H, Ikeda F, Yanase M, Toyoda H, Genda T, Umemura T, Yatsuhashi H, Ide T, Toda N, Nirei K, Ueno Y, Nishigaki Y, Betular J, Gao B, Ishizaki A, Omote M, Mo H, Garrison K, Pang PS, Knox SJ, Symonds WT, McHutchison JG, Izumi N, Omata M. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis. 2015 Jun;15(6):645-53. doi: 10.1016/S1473-3099(15)70099-X. Epub 2015 Apr 8. |
Not provided
Not provided
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.
18 months after study completion
A secured external environment with username, password, and RSA code.
421 participants were screened.
Participants were enrolled study sites in Japan. The first participant was screened on 15 October 2013. The last study visit occurred on 22 August 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF (Treatment Naive) | Treatment-naive participants received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for up to 12 weeks. |
| FG001 | LDV/SOF+RBV (Treatment Naive) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| RBV | Drug | RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg) |
|
|
Virologic failure was defined as On-treatment virologic failure:
Virologic relapse: - Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. |
| Up to Posttreatment Week 24 |
| Kurume |
| Fukuoka |
| 830-0011 |
| Japan |
| Ōgaki | Gifu | 503-0864 | Japan |
| Sapporo | Hokkaido | 060-8648 | Japan |
| Nishinomiya | Hyōgo | 663-8501 | Japan |
| Matsumoto | Nagano | 390-8621 | Japan |
| Ōmura | Nagasaki | 856-8562 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Izunokuni | Shizuoka | 410-2295 | Japan |
| Chiyoda-ku | Tokyo | 101-8643 | Japan |
| Itabashi-ku | Tokyo | 173-8610 | Japan |
| Musashino | Tokyo | 180-8610 | Japan |
| Shinjuku | Tokyo | 162-8566 | Japan |
| Kofu | Yamanashi | 400-0027 | Japan |
| Akita | 010-0933 | Japan |
| Chiba | 260-0856 | Japan |
| Gifu | 500-8513 | Japan |
| Okayama | 700-8558 | Japan |
| Yamagata | 990-9585 | Japan |
Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus ribavirin (RBV) tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
| FG002 | LDV/SOF (Treatment Experienced) | Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks. |
| FG003 | LDV/SOF+RBV (Treatment Experienced) | Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF (Treatment Naive) | Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks. |
| BG001 | LDV/SOF+RBV (Treatment Naive) | Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks. |
| BG002 | LDV/SOF (Treatment Experienced) | Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks. |
| BG003 | LDV/SOF+RBV (Treatment Experienced) | Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Hepatitis C Virus (HCV) RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| Cirrhosis Status | Number | participants |
| ||||||||||||||||
| Response to Prior HCV Treatment | Number | participants |
|
| 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 (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Treatment-naive participants in the Full Analysis Set (randomized, received at least 1 dose of study drug, and had chronic genotype 1 (1a, 1b, or mixed 1a/1b) HCV infection) without cirrhosis were analyzed. | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Sustained Virologic Response 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. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Virologic Failure | Virologic failure was defined as On-treatment virologic failure:
Virologic relapse: - Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 12 weeks |
|
|
Up to 12 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
Not provided
| 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 | Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks. | 3 | 171 | 77 | 171 | ||
| EG001 | LDV/SOF+RBV | Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks. | 2 | 170 | 90 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| ≥ 65 years |
|
| Male |
|
| ≥ 800,000 IU/mL |
|
| CT |
|
| TT |
|
| Yes |
|
| Relapse/Breakthrough |
|
| IFN Intolerant |
|
| < 0.001 |
Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test. |
| 2-Sided |
| Superiority or Other |
|
|
|
|
|
| OG003 | LDV/SOF+RBV (Treatment Experienced) | Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks. |
|
|
|