Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone
Hepatocellular CarcinomaHepatitis B1 moreThis is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection. Participants will be dosed with either MTL-CEBPA (an experimental treatment) and sorafenib or sorafenib alone. The MTL-CEBPA is administered once every 3 weeks via intravenous infusion. Sorafenib is taken orally from Day 8 for the combination group or Day 1 for the sorafenib alone group at a dose of 400 mg twice a day. Participants will receive 3 week cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or death occurs. The combination of MTL-CEBA and sorafenib combination of treatment was tested in a previous Phase I study (OUTREACH) which showed anti-tumour activity along with a good safety and toxicity profile.
Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic...
Liver CancerTo learn if giving immune checkpoint therapy (such as atezolizumab) and bevacizumab to patients who have HCC and are receiving DAAs may help to control HCC and hepatitis C.
HCV Test and Treat Utilizing Simplified HCV Patient Education
Hepatitis CThe study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis C virus (HCV) treatment initiation and treatment completion.
Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).
Liver CirrhosisHepatitis C2 moreProlonged-Release Pirfenidone (PR-PFD) is an anti-fibrogenic and anti-inflammatory molecule used for the treatment of idiopathic pulmonary fibrosis (approved by FDA) and liver fibrosis (approved in Mexico by COFEPRIS). PFD effects are mediated in part through inhibition of TGFβ, TNFα, IL-1 and IL-6, along with NFκB activation down-regulation causing reduced TNFα and IFNγ levels. The aim of this protocol is to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing...
Hepatitis CLiver Inflammation1 moreThis study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.
Rapid HCV Treatment Access for Persons Who Use Drugs
Hepatitis C Virus InfectionResponse to Therapy ofThis study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups: Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.
Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in...
Hepatitis CErectile DysfunctionChronic hepatitis C virus (HCV) infection is a systematic disease that affects several aspects of patients' well-being, including physical, mental, social, and sexual quality of life. In recent years, this clinical trial aims to search the Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Hepatitis Men With Sexual Dysfunction Complaint
A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
End Stage Renal DiseaseThe Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The one-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants (these patients are called Transplant Cohort). The mortality rate of kidney transplant candidates who enroll in THINKER-NEXT and consent to offers of kidneys from HCV-infected donors will be compared to matched wait-listed patients who do not consent to receive HCV-infected kidneys (these patients are called Wait-list Cohort). Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.
PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders
HCV InfectionBeta Thalassemia MajorThis is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV infected children with hematological Disorders. to develop predictive pharmacokinetic model for the 3 moieties in the studied population. In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) orally, once daily with food.
Tele-Harm Reduction
IV Drug UsageHIV Infections1 moreThe purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.