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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The primary objectives of this study are to describe the efficacy of:
The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 weeks SOF/LED | Experimental | Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. |
|
| 12 weeks SOF/LED | Experimental | Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8 weeks SOF/LED | Drug | Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment | 12 weeks after end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Day 1 of treatment to 12 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mindie H Nguyen, MD, MAS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | United States | ||
| San Jose Gastroenterology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23944316 | Background | Lawitz E, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 Aug 15;369(7):678-9. doi: 10.1056/NEJMc1307641. No abstract available. | |
| 21038410 | Background | Lam KD, Trinh HN, Do ST, Nguyen TT, Garcia RT, Nguyen T, Phan QQ, Nguyen HA, Nguyen KK, Nguyen LH, Nguyen MH. Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6. Hepatology. 2010 Nov;52(5):1573-80. doi: 10.1002/hep.23889. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 8 Weeks SOF/LED | Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. 8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
| FG001 | 12 Weeks SOF/LED | Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. 12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
| FG002 | Extended Treatment to 12 Weeks SOF/LED | Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 8 Weeks SOF/LED | Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. 8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
| 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 | Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment | Posted | Count of Participants | Participants | 12 weeks after end of therapy |
|
For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product.
Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
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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 | 8 Weeks SOF/LED | Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. 8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper GI Bleed | Gastrointestinal disorders | Systematic Assessment | H.pylori-related bleeding gastric ulcer unrelated to study treatment. Subject achieved SVR 12. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Fatigue |
Our population was small and our study was not powered to be able to determine significant differences between groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mindie H. Nguyen, MD, MAS | Stanford University Medical Center | 650-4985691 | mindiehn@stanford.edu |
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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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|
|
| 12 weeks SOF/LED | Drug | Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
|
|
| San Jose |
| California |
| 95128 |
| United States |
| Liver and Digestive Consultants | Houston | Texas | 77072 | United States |
| Digestive Health Associates | Plano | Texas | 75093 | United States |
| 24725238 | Background | Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11. |
| 24725239 | Background | Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11. |
| 21623850 | Background | Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011 Aug;34(3):286-96. doi: 10.1111/j.1365-2036.2011.04714.x. Epub 2011 May 29. |
| BG001 | 12 Weeks SOF/LED | Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. 12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. |
| BG002 | Extended Treatment to 12 Weeks SOF/LED | Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Comorbidities | Count of Participants | Participants |
|
| HCV Genotype SubType | Count of Participants | Participants |
|
| Baseline Cirrhosis | Count of Participants | Participants |
|
| Decompensated Cirrhosis | Decompensated cirrhosis is defined as presence/history of variceal bleeding, hepatic encephalopathy, or ascites at baseline. | Count of Participants | Participants |
|
| Hepatocellular Carcinoma | Count of Participants | Participants |
|
| Prior Treatment | Count of Participants | Participants |
|
| Proton Pump Inhibitor (PPI) usage | Count of Participants | Participants |
|
| MELD, cirrhotics only | The Model for End-Stage Liver Disease (MELD) Score uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The total possible range for MELD scores is 6 (less ill) to 40 (gravely ill). | Mean | Standard Deviation | units on a scale |
|
| log10 HCV RNA | Mean | Standard Deviation | log10 (IU/ml) |
|
| White Blood Cell Count (WBC) | Mean | Standard Deviation | K/uL |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Platelets | Median | Inter-Quartile Range | K/uL |
|
| Creatinine | Mean | Standard Deviation | mg/dL |
|
| International Normalized Ratio (INR) | The INR is based on the ratio of the patient's prothrombin time and the normal mean prothrombin time. The normal range for a healthy person who is not on anticoagulant therapy is 0.8-1.2, while higher values are targeted for people on anticoagulant therapy. | Mean | Standard Deviation | ratio |
|
| Total bilirubin | Mean | Standard Deviation | mg/dL |
|
| Aspartate Aminotransferase (AST) | AST is an enzyme that is secreted from the liver and can be found in liver, heart, muscle tissue, pancreas and kidneys. Elevated levels of AST may indicate inflammation or liver damage. Normal range for AST is typically 10-40 U/L. | Median | Inter-Quartile Range | U/L |
|
| Alanine Aminotransferase (ALT) | ALT is an enzyme that is secreted by the liver into the blood. Main storage of this enzyme is in the liver and elevated levels of ALT in the blood may indicate liver inflammation or damage. Normal range for ALT is typically between 7-56 U/L. | Median | Inter-Quartile Range | U/L |
|
| Albumin | Mean | Standard Deviation | g/dL |
|
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
| OG002 | Treatment Extension to 12 Weeks SOF/LED | Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference |
|
|
| Secondary | Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Posted | Count of Participants | Participants | Day 1 of treatment to 12 weeks post treatment |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | 12 Weeks SOF/LED | Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. 12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. | 0 | 36 | 2 | 36 | 5 | 36 |
| EG002 | Extended Treatment to 12 Weeks SOF/LED | Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference | 0 | 4 | 0 | 4 | 0 | 4 |
|
| Surgical correction of left wrist fracture | Surgical and medical procedures | Systematic Assessment | Surgical correction for wrist fracture due to a mechanical fall unrelated to study treatment. Subject achieved SVR 12. |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |