Hepatitis C Treatment Study in Myanmar
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A vizsgálat adatai
- Ki végzi
- Myanmar Oxford Clinical Research Unit
- Azonosító
- NCT03158857
- A regiszteradat frissítve
- 2021. december 17.
- Eredeti leírás
Hepatitis C is an important health problem in Myanmar affecting around 3% of the population. New drugs have been developed which have transformed the treatment of this disease around the world with very high success rates. Two of these drugs are now registered for use in Myanmar. In this study 200 patients with chronic hepatitis C(100 with HIV co-infection) will be assessed and started on the new treatment. We will observe them and measure treatment effectiveness and tolerability. In 24 patients extra blood samples will be taken for drug measurements to describe the effect of the drugs on patients in Myanmar in more detail.A teljes eredeti leírásKevesebb
A Clinical and Pharmacokinetic Study of the Effectiveness of Hepatitis C Treatment (Sofosbuvir+Daclatasvir) in HIV Co-infected and Non HIV Co-infected Patients at the Level of Non-hospital Based Management in Myanmar
Hepatitis C is an important health problem in Myanmar affecting around 3% of the population. New drugs have been developed which have transformed the treatment of this disease around the world with very high success rates. Two of these drugs are now registered for use in Myanmar. In this study 200 patients with chronic hepatitis C(100 with HIV co-infection) will be assessed and started on the new treatment. We will observe them and measure treatment effectiveness and tolerability. In 24 patients extra blood samples will be taken for drug measurements to describe the effect of the drugs on patients in Myanmar in more detail.
Bevonási feltételek: Age > 18- years, male or female; Willing and able to comply with program assessment, including routine tests, attendance for follow up and compliance with medicine taking; Able to provide written agreement (or witnessed in the case of patients who cannot read and write); Have a diagnosis of hepatitis C (based on a hepatitis C point-of-care test and then confirmed by PCR) with or without HIV; Additional inclusion criteria for PK sub-study; HIV well-controlled on current therapy (co-infected patients only); Willing and able to comply with the additional blood sampling in the PK-PD sub-study protocol for the duration of the study.
Kizáró feltételek: Previous HCV therapy; Clinical evidence of decompensated cirrhosis with current or previous episode of ascites, variceal bleed, encephalopathy, and treated hepatocellular cancer (HCC) [Child-Pugh score B or C]; Presence of concomitant medical or social situation that would make it difficult for the patient to comply with program protocol or put the patient at additional risk; Concomitant medications that cause unacceptable drug-drug interactions. Additional exclusion criteria for PK sub-study; HCV PCR negative; Patients with significant renal impairment with Cr Cl < 50 ml/min; Known hypersensitivity to any part of the drug regime; Current pregnancy (pregnancy test to be performed in women of child-bearing age); Presence of significant comorbidity with life expectancy of less than 12 months; Anaemia (Hb <100 mg/L).