Hepatitis C Treatment Study in Myanmar (NCT03158857) | Clinical Trial Compass
WithdrawnNot Applicable
Hepatitis C Treatment Study in Myanmar
Stopped: Long local IRB process to meet with the treatment deadline
Burma0Started 2022-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. Current pregnancy (pregnancy test to be performed in women of child-bearing age)
. Patients with significant renal impairment with Cr Cl \< 50 ml/min.
✕. Known hypersensitivity to any part of the drug regime.
✕. Presence of significant comorbidity with life expectancy of less than 12 months.
✕. 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