EUCTR2013-002802-30-AT进行中（未招募）不适用
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the subject.
- •2. Male or female, Age > or = 18 years
- •3. Chronic genotype 1 and 4
- •4. HCV RNA infection with quantifiable virus at Screening
- •5. Confirmation of chronic (non-acute) HCV infection documented by either:
- •a. A positive anti-HCV antibody test or positive HCV RNA or positive HCV
- •genotyping test at least 6 months prior to the Day 1 visit, or
- •b. A liver biopsy performed prior to the Day 1 visit with evidence of chronic HCV
- •6. Screening ECG without clinically significant abnormalities.
- •7. Negative serum pregnancy test for female subjects (unless surgically sterile or greater
- •than two years post-menopausal; please see Appendix 4).
- •8. Male subjects and female subjects of childbearing potential who engage in heterosexual
- •intercourse must agree to use protocol specified method(s) of contraception as described
- •in Appendix 4.
- •9. Lactating females must agree to discontinue nursing before the study drugs are
- •administered
- •10. Subject must be able to comply with the dosing instructions for study drug administration
- •and able to complete the study schedule of assessments, including all required
- •post-treatment visits.
- •11. Ability to determine the presence/absence of cirrhosis for all groups except Cohort B,
- •Group 7 (which may or may not have cirrhosis)
- •a. Cirrhosis is defined as any one of the following:
- •Liver biopsy showing cirrhosis
- •Fibroscan (in countries where locally approved) showing cirrhosis or results > 12.5 kPa
- •A FibroTest® score of >0.75 AND an AST:Platelet Ratio Index (APRI) of
- •>2 performed during screening
- •b. Absence of cirrhosis is defined as any one of the following:
- •Liver biopsy within 2 years of Screening showing absence of cirrhosis
- •Fibroscan (in countries where locally approved) with a result of = 12.5 kPa within = 6 months of Baseline/Day1
- •A FibroTest® score of = 0.48 AND APRI of = 1 performed during Screening In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy is required; liver biopsy results will supersede blood test results and be considered definitive.
- •Inclusion Criteria Exclusively for Cohort A
- •12. Has never received a liver transplant, and if listed for transplant, expected to be at least 12 weeks prior to transplant (from anticipated Day 1 of dosing). The subject may be a candidate for a living donor transplant, as long as it is anticipated to be at least 12 weeks before the transplant surgery will occur.
- •Inclusion Criteria Exclusively for Cohort B, all Groups
- •13. Post-liver transplant (primary or secondary, cadaveric or living donor), at least 3 months since transplant procedure for all groups except Cohort B, Group 4, which must be at least 2 months since the transplant procedure).
- •14. Subjects may be on the waiting list for a second or third transplant. Subjects who are on the waiting list for a liver transplant must be waiting to receive an HCV negative organ.
- •Inclusion Criteria Exclusively for Cohort B, Group 7 (FCH) only
- •15. Subject must be within 18 months of transplant at screening
- •16. Histological evidence of fibrosing cholestatic hepatitis on post-transplant liver biopsy performed within 6 months of scree
排除标准
- •1. Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- •2. HIV infection or chronic hepatitis B virus (HBV) infection (HBsAg positive)
- •3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- •4. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
- •5. Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last
- •6 months or during screening
- •6. Current malignancy (with exception of certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative), including hepatocellular carcinoma
- •7. Treatment with IFN, RBV, telaprevir or boceprevir or any other approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
- •8. Any prior exposure to an HCV NS5a specific inhibitor
- •9. Use of GM-CSF, epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of Screening
- •10. History of clinically significant medical condition associated with other chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, a-1-antitrypsin deficiency, alcoholic liver disease, non-alcoholic steatohepatitis, or toxin exposures) that may affect the ability to respond to HCV therapy.
- •11. Active spontaneous bacterial peritonitis at screening
- •12. Hematological and biochemical parameters, including:
- •a. Hemoglobin (Hb) < 10 g/dL
- •b. Platelets = 30,000/ mm3
- •c. ALT, AST, or alkaline phosphatase = 10 ULN, sodium <125 mmol/L
- •d. Total bilirubin > 10mg/dL (except for the FCH cohort)
- •e. Serum creatinine > 2.5x upper limit of normal and/or evidence of renal impairment (CrCl < 40 mL/min).
- •13. Infection requiring systemic antibiotics at the time of screening
- •14. Participation in a clinical study with an investigational drug or biologic within 1 month prior to screening visit, unless information on the investigational drug is available to indicate that there is no potential drug interaction (safety or efficacy)
- •15. Active or recent history (= 6 months) of drug or alcohol abuse
- •16. Any contraindication to RBV therapy, per the approved package insert
- •17. Any history of organ transplant other than liver or kidney
- •18. Any medications from Section 5.4 prohibited from used within 28 days prior to the Day 1 visit through the end of treatment
- •19. Known hypersensitivity to RBV, LDV, SOF, or formulation excipients.
- •Exclusion criteria Exclusively for Cohort A subjects:
- •20. Medical justification for any MELD exception points (for HCC, current hepatopulmonary syndrome, intractable encephalopathy, or any other reason)
- •21. History of hepatopulmonary syndrome
- •22. Chronic use of systemic immunosuppressive agents (for autoimmune diseases, etc)
- •Exclusion Criteria Exclusively for Cohort B, all Groups:
- •23. Current use of corticosteroids at any dose > 10 mg of prednisone/day (or equivalent dose of other corticosteroid)
- •24. Histological evidence of unresolved rejection requiring treatment or expected to require treatment during the study period
- •25. Use or planned use of T-cell depleting/masking antibodies, systemic antineoplastic agents, or cyclosporine at a dose of > 300 mg/day
- •26. Subjects with a Child-Pugh Score of 13-15, due to the serious medical condition and poor prognosis for these patients
- •Exclusion criterio
研究者
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