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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-194989 | Registry Identifier | Japan Pharmaceutical Information Center |
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The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | Tablets administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug | TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug. | First dose date up to Week 12.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24) |
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Key Inclusion 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 |
|---|---|---|---|---|---|---|
| Chiba University Hospital | Chiba | 260-8677 | Japan | |||
| Fukui-ken Saiseikai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802063 | Derived | Takehara T, Izumi N, Mochida S, Genda T, Fujiyama S, Notsumata K, Tamori A, Suzuki F, Suri V, Mercier RC, Matsuda T, Matsuda K, Kato N, Chayama K, Kumada H. Sofosbuvir-velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan. Hepatol Res. 2022 Oct;52(10):833-840. doi: 10.1111/hepr.13810. Epub 2022 Aug 8. |
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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.
41 participants were screened.
Participants were enrolled at study sites in Japan. The first participant was screened on 16 October 2019. The last study visit occurred on 25 June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks. |
| 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 | Jul 3, 2019 | Feb 28, 2022 |
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SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment. |
| Posttreatment Week 24 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| First dose date up to posttreatment Week 24 |
| Fukui |
| 918-8503 |
| Japan |
| Japanese Red Cross Fukuoka Hospital | Fukuoka | 815-8555 | Japan |
| Hiroshima University Hospital Institution Review Board | Hiroshima | 734-8551 | Japan |
| Iizuka Hospital | Iizuka | 820-8505 | Japan |
| Nippon Medical School Hospital | Inzai-shi | 2701694 | Japan |
| Saitama Medical University Hospital | Iruma | 350-0495 | Japan |
| Juntendo University Shizuoka Hospital | Izunokuni | 410-2295 | Japan |
| Nara Medical University Hospital | Kashihara-shi | 634-8522 | Japan |
| Toranomon Hospital Kajigaya | Kawasaki-shi | 213-8587 | Japan |
| Kumamoto Shinto General Hospital | Kumamoto | 862-8655 | Japan |
| Kurme University Hospital | Kurume-shi | 830-0011 | Japan |
| Matsuyama Red Cross Hospital | Matsuyama | 7908524 | Japan |
| Japanese Red Cross Musashino Hospital | Musashino | 180-8610 | Japan |
| Hyogo College of Medicine Hospital Institutional Review Board | Nishinomiya | 663-8501 | Japan |
| National Hospital Organization Nagasaki Medical Center | Omura-shi | 856-8562 | Japan |
| Osaka Red Cross Hospital | Osaka | 543-8555 | Japan |
| Osaka City University Hospital | Osaka | 545-8586 | Japan |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo | 060-0033 | Japan |
| Osaka University Hospital | Suita-shi | 565-0871 | Japan |
| Kagawa Prefectural Central Hospital | Takamatsu | 760-8557 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included all participants who took at least 1 dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL | Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | 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 (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set included all enrolled participants who took at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug | TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Week 12.1 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24) | SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 24 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to posttreatment Week 24 |
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All-Cause Mortality: Enrollment to Posttreatment Week 24; Adverse Events: First dose date up to Week 12.1 plus 30 days
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse Events: Safety Analysis Set included all participants who took 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 | SOF/VEL | Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks. | 1 | 37 | 1 | 37 | 5 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | 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 |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2021 | Feb 28, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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