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The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF | Experimental | LDV/SOF FDC for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug | First dose date up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With HCV RNA < LLOQ While on Treatment |
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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 |
|---|---|---|---|---|---|---|
| Changhua | Taiwan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients With Chronic Hepatitis C and Hepatitis B Coinfection: a Phase 3 Study in Taiwan [Poster SAT-243]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria. | ||
| Result | Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Declines in HBsAg Levels Observed During Treatment With Ledispavir/Sofosbuvir in Patients With Chronic Hepatitis B Virus and Hepatitis C Virus Infection [Poster 1083]. 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. | ||
| 29174546 | Result | Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, Chang TT, Massetto B, Yang JC, Yun C, Knox SJ, Osinusi A, Camus G, Jiang D, Brainard DM, McHutchison JG, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV. Gastroenterology. 2018 Mar;154(4):989-997. doi: 10.1053/j.gastro.2017.11.011. Epub 2017 Nov 22. |
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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.
135 participants were screened.
Participants were enrolled at study sites in Taiwan. The first participant was screened on 22 December 2015. The last study visit occurred on 07 November 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF FDC | Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set included participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF FDC | LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
|
Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
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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 FDC | LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks. | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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LLOQ = 15 IU/mL |
| Weeks 1, 2, 4, 8, and 12 |
| Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | LLOQ = 15 IU/mL | Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 |
| HCV RNA Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as :
| First dose date up to Posttreatment Week 12 |
| Plasma HBV DNA Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 |
| Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
| HBsAg Level Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 |
| HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
| Serum LOXL-2 Level Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 |
| Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 | Posttreatment Weeks 4, 12, and 36 |
| Percentage of Participants That Required HBV Therapy During the Study | First dose date up to Posttreatment Week 108 |
| Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 | FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:
| Posttreatment Weeks 12, 60, and 108 |
| Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study | First dose date up to Posttreatment Week 108 |
| Chiayi City |
| Taiwan |
| Kaohsiung City | Taiwan |
| Keelung | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Result | Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients with Chronic Hepatitis C and Hepatitis B Coinfection: A Phase 3 Study in Taiwan [Presentation]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands. |
| 34864948 | Derived | Liu CJ, Sheen IS, Chen CY, Chuang WL, Wang HY, Tseng KC, Chang TT, Yang J, Massetto B, Suri V, Camus G, Jiang D, Zhang F, Gaggar A, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment. Clin Infect Dis. 2022 Aug 31;75(3):453-459. doi: 10.1093/cid/ciab971. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| IL28b Status | CC and CT alleles are different forms of the IL28b gene. | Count of Participants | Participants | No |
|
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
|
| HCV RNA Category | Count of Participants | Participants | No |
|
| Cirrhosis status | Count of Participants | Participants | No |
|
| Fibroscan Score | FibroScan® is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:
| Mean | Standard Deviation | kPa |
|
| Hepatitis B Virus (HBV) DNA | Mean | Standard Deviation | log10 IU/mL |
|
| Plasma HBV DNA | Mean | Standard Deviation | IU/mL |
|
| HBsAg | Mean | Standard Deviation | IU/mL |
|
| Serum Lysyl Oxidase-Like 2 (LOXL-2) Level | Mean | Standard Deviation | pg/mL |
|
| HCV Genotype | HCV Genotype 1 indicates genotype 1 with no confirmed subtype (eg, 1a, 1b or mixed 1a/1b). | Count of Participants | Participants | No |
|
|
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| Primary | Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug | Safety Analysis Set included participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to 12 weeks |
|
|
|
| Secondary | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment. | Participants in Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
|
|
|
| Secondary | Percentage of Participants With HCV RNA < LLOQ While on Treatment | LLOQ = 15 IU/mL | Participants in Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | LLOQ = 15 IU/mL | Participants in Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 |
|
|
|
| Secondary | HCV RNA Change From Baseline While on Treatment | Participants in Full Analysis Set were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as :
| Participants in Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Posttreatment Week 12 |
|
|
|
| Secondary | Plasma HBV DNA Change From Baseline While on Treatment | Participants in Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Participants in Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
|
|
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| Secondary | HBsAg Level Change From Baseline While on Treatment | Participants in Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Participants in Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
|
|
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| Secondary | Serum LOXL-2 Level Change From Baseline While on Treatment | Participants in Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 | Participants in Full Analysis Set were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Posttreatment Weeks 4, 12, and 36 |
|
|
|
| Secondary | Percentage of Participants That Required HBV Therapy During the Study | Participants in Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Posttreatment Week 108 |
|
|
|
| Secondary | Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 | FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:
| Participants in Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | kPa | Posttreatment Weeks 12, 60, and 108 |
|
|
|
| Secondary | Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study | Participants in Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Posttreatment Week 108 |
|
|
|
| 111 |
| 4 |
| 111 |
| 24 |
| 111 |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | 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:
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Week 8 |
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| Week 12 |
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| Posttreatment Week 48 |
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| Posttreatment Week 60 |
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| Posttreatment Week 72 |
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| Posttreatment Week 84 |
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| Posttreatment Week 96 |
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| Posttreatment Week 108 |
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| Title | Measurements |
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| Change at Week 4 |
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| Change at Week 8 |
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| Change at Week 12 |
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| Change at Posttreatment Week 24 |
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| Change at Posttreatment Week 36 |
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| Change at Posttreatment Week 48 |
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| Change at Posttreatment Week 60 |
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| Change at Posttreatment Week 72 |
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| Change at Posttreatment Week 84 |
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| Change at Posttreatment Week 96 |
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| Change at Posttreatment Week 108 |
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| Title | Measurements |
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| Change at Week 4 |
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| Change at Week 8 |
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| Change at Week 12 |
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| Change at Posttreatment Week 24 |
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| Change at Posttreatment Week 36 |
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| Change at Posttreatment Week 48 |
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| Change at Posttreatment Week 60 |
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| Change at Posttreatment Week 72 |
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| Change at Posttreatment Week 84 |
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| Change at Posttreatment Week 96 |
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| Change at Posttreatment Week 108 |
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| Title | Measurements |
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| Change at Week 4 |
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| Change at Week 8 |
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| Change at Week 12 |
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| Posttreatment Week 108 |
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