- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03158857
Hepatitis C Treatment Study in Myanmar
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
Study Overview
Detailed Description
Data concerning Hepatitis C virus (HCV) prevalence in Myanmar is scarce. Preliminary results of a survey, conducted in 2015 in different areas in Myanmar estimated a seroprevalence of HCV of around 2.65 %, which represents 1.3 million infected patients. Genotype 6 was mostly found in the northern cities and genotype 3 in the southern and western cities of Myanmar. However, treatment options for HCV in Myanmar remain limited currently, including for patients with HIV co-infection who are generally considered high priority given their increased risk for liver disease.
New direct acting antiviral therapies which can achieve high rates of sustained virological response (SVR) (>90%), defined as complete suppression of the virus 12 weeks after completion of antiviral therapy, are becoming increasingly available worldwide.
In Myanmar, in mid-2015, the guideline for the treatment of chronic hepatitis C infection of the Myanmar GI and Liver Society was revised in line with the recent development of Directly Acting Antiviral (DAA) drugs. This observational study will follow the recommendations for patient care presented in this guideline. Two hundred patients with chronic hepatitis C (100 with HIV co-infection) will be recruited in this observational study of routine care with two newly available antiviral drugs (sofosbuvir+ daclatasvir) in two different groups of patients (with and without HIV coinfection) at two centres in Yangon, Myanmar. Their response to treatment will be monitored. In addition a pharmacokinetic study is planned in a subset of patients to characterise any determinants of treatment response or tolerability in patients in Myanmar. This study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirements
Study Type
Contacts and Locations
Study Locations
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Yangon, Myanmar
- Medical Action Myanmar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
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
Exclusion Criteria
- Current pregnancy (pregnancy test to be performed in women of child-bearing age)
- Previous HCV therapy.
- HCV PCR negative
- 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
- Concomitant medications that cause unacceptable drug-drug interactions. Additional exclusion criteria for PK sub-study
1. Anaemia (Hb <100 mg/L)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Hepatitis C monoinfection
Sofosbuvir 400 mg tablet once a day + Daclatasvir 60mg tablet once a day Patients with evidence of cirrhosis will be offered treatment for 24 weeks, those who are not cirrhotic will be offered 12 weeks of treatment. |
These drugs are being offered as part of routine care
Other Names:
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Hepatitis C and HIV co-infection
Sofosbuvir tablet 400 mg once a day + Daclatasvir tablet 90 mg once a day (increased dose in patients receiving efavirenz. Patients on an alternative HIV drug regimen will receive standard dose i.e. 60 mg) Patients with evidence of cirrhosis will be offered treatment for 24 weeks, those who are not cirrhotic will be offered 12 weeks of treatment. |
These drugs are being offered as part of routine care
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SVR12
Time Frame: 12 weeks
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Sustained Virological Response 12 weeks after completion of therapy
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AEs
Time Frame: 12-24 weeks
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Frequency of adverse events
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12-24 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration
Time Frame: 2 years
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C max
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2 years
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Area under the curve
Time Frame: 2 years
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AUC
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2 years
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Elimination half-life
Time Frame: 2 years
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t1/2
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Ni Ni Tun, MB BS, Medical Action Myanmar; MOCRU
- Principal Investigator: Khin Pyone Kyi, MB BS, Myanmar Liver Foundation
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
Other Study ID Numbers
- OXTREC 3-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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