EUCTR2017-000179-98-GB进行中（未招募）1 期
An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects who Participated in a Prior Gilead-Sponsored HCV Treatment Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •2) Male or female, age =18 years
- •3) HCV RNA = LLOQ at Screening
- •4) Received SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks in GS-US-367-1172 (POLARIS-2), GS-US-367-1173 (POLARIS-3), or GS-US-367-1170 (POLARIS-4), or received HCV treatment with a DAA-based regimen in another Gilead-sponsored study, with approval from Gilead Sciences prior to Screening
- •5) Cirrhosis Determination
- •6) Liver imaging within 6 months prior to Day 1 is required in cirrhotic subjects to exclude hepatocellular carcinoma (HCC)
- •7) Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
- •8) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •9) Lactating females must agree to discontinue nursing before starting study drug
- •10) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator
- •11) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1) Current or prior history of any of the following:
- •a. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
- •b. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- •c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- •d. Hepatic decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
- •e. Solid organ transplantation
- •f. Significant cardiac disease
- •g. Unstable psychiatric condition including hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening
- •h. Malignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection. Subjects
- •under evaluation for possible malignancy are not eligible.
- •i. Significant drug allergy (e.g., hepatotoxicity)
- •2) Screening ECG with clinically significant abnormalities
- •3) Subjects with laboratory parameters at screening as defined in the protocol
- •4) Prior treatment with SOF/VEL/VOX±RBV for =12 weeks
- •5) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
- •6) Infection with human immunodeficiency virus (HIV)
- •7) Hepatitis B surface antigen positive (HBsAg+) at Screening
- •8) Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator
- •9) Use of any prohibited concomitant medications
- •10) Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
研究者
相似试验
进行中（未招募）
1 期
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir in Adults with Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, with Severe Kidney Impairment or End-Stage Kidney Disease (RUBY-II)EUCTR2015-002012-33-ESAbbVie Deutschland GmbH & Co. KG18
进行中（未招募）
1 期
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritabprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated CirrhosisEUCTR2014-001477-13-DEAbbVie Deutschland GmbH & Co. KG60
已完成
1 期
Topical Hidracare Solution in Participants with Mild to Moderate Hidradenitis SuppurativaHidradenitis suppurativaACTRN12619001734156Aerotech Australia Pty Ltd19
已完成
4 期
A phase IV study to Evaluate The Safety And Efficacy Of Amphotericin B Lipid Suspension in Immunocompromised patients with Invasive Fungal Infections.CTRI/2010/091/003012Intas Pharmaceutical Ltd60
进行中（未招募）
不适用
ocal Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDsMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid arthritisEUCTR2008-004126-16-FIRoche Oy