ICH GCP | Clinical Trials Registry

Drugs for Neglected Diseases 

Ministry of Health, Malaysia 

No

Drug

sofosbuvir 

combination sofosbuvir ravidasvir treatment for non cirrhotic and compensated cirrhotic patients

ravidasvir

Inclusion Criteria: - Evidence of chronic HCV infection, defined as: Positive anti-HCV antibody or detectable HCV RNA or HCV genotype at least 6 months before screening and HCV viral load ≥104 IU/mL at the time of screening In subjects without documented HCV test results 6 months before screening, chronic hepatitis C infection can be assumed if risk exposures occurred > 6 months prior to screening and HCV viral load ≥104 IU/mL at the time of screening. - Willing and able to provide written informed consent. - Men and women age ≥ 18 years and < 70 years. - Body Mass Index (BMI) of 18 to 35 kg/m2. - Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. - Women with a negative pregnancy test at screening and baseline. - Women of child bearing potential who accept effective contraception from 2 weeks prior to study day 1 until 1 month post-treatment (Double contraceptive method including at least one barrier method). A woman is of non-child bearing potential if she (a)reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b)had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy. - Subjects who are compliant in opioid substitution maintenance program may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules. Active illicit drug users may also be enrolled, as a pre-stratified subpopulation, however their data will not contribute in the primary intent to treat analysis Exclusion Criteria: - Decompensated cirrhosis defined as: Evidence of advanced stage liver cirrhosis and Child-Turcotte-Pugh (CTP) Class B or C or CTP score >6) or current/past history of decompensation including ascites, variceal bleeding, spontaneous bacterial peritonitis, or hepatic encephalopathy. - Hepatocellular carcinoma - To exclude hepatocellular carcinoma (HCC), liver imaging within 6 months prior to screening is required for all subjects with cirrhosis and this must continue periodically as in routine HCC surveillance. - Additional laboratory exclusion criteria: - cirrhotic subjects with albumin < 2.8 g/dL - direct bilirubin > 3xULN - AST, ALT > 10xULN - Low neutrophil count (≤599 cells/mm3), hemoglobin (<9.0 g/dL for male, <8.5 g/dL for female), platelets (<50000 cells/mm3 ) classified as ≥ Grade 3 - Patients with serum creatinine > 1.5 ULN or end stage renal disease - Hepatitis B co-infection (HBsAg positive) - Pregnancy, as documented by positive pregnancy tests at screening and baseline - Breastfeeding - Subjects currently receiving or unable to stop the use for at least 1 week prior to receiving the first dose of study drug any medications or herbal supplements known to be potent inhibitors or moderate inducers of cytochrome P450 (CYP) 3A4 and potent inducers of P-glycoprotein. This includes subjects who are on amiodarone or other contraindicated drugs - Participation in other clinical trials within 3 months, except upon agreement with the study steering committee. - Any clinically significant findings or unstable condition during the screening, medical history or physical examination that, in the investigator's opinion, would compromise participation in this study . This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions. - Current or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents. - History of solid organ or bone marrow transplantation. - Any prior NS5A inhibitors therapy. - Patients with significant cardiovascular conditions including myocardial infarction within the previous 6 months or heart failure NYHA class III or IV; history of Torsade de pointes; QTcF value ≥ 450 milliseconds or third degree heart block; - Use of medications associated with QT prolongation concurrently or within the 30 days prior to Screening Visit, including: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants. Note: An electrocardiogram will be performed at screening and in case of doubt, the subject will be referred to a cardiologist for advice. Subjects will be instructed to immediately consult if they experience dizziness, light headedness or fainting spell. - HIV/HCV co-infected patients not yet on stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.

All

18 Years

70 Years

No

Lallemand Marc, MD

+41 79 293 12 05

Sponsor

Sofosbuvir

francois simon

+41791967868

Undecided

Non-Randomized

Parallel Assignment

Treatment

None (Open Label)