Clinical Trials

MainTitle

Hepatitis C Treatment Study in Myanmar

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified May 2017 by Myanmar Oxford Clinical Research Unit

Sponsor
Myanmar Oxford Clinical Research Unit

Collaborator
Myanmar Liver foundation (MLF)
Medical Action Myanmar (MAM)

Information provided by (Responsible Party)
Myanmar Oxford Clinical Research Unit
ClinicalTrials.gov Identifier
NCT03158857

First received: May 16, 2017
Last updated: August 30, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
Hepatitis C

Drug : Sofosbuvir 400 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Myanmar Oxford Clinical Research Unit:

Primary Outcome Measures

  • SVR12 [ Time Frame: 12 weeks ]
    Sustained Virological Response 12 weeks after completion of therapy
Secondary Outcome Measures:
  • AEs [ Time Frame: 12-24 weeks ]
    Frequency of adverse events
Other Outcome Measures:
  • Maximum plasma concentration [ Time Frame: 2 years ]
    C max
  • Area under the curve [ Time Frame: 2 years ]
    AUC
  • Elimination half-life [ Time Frame: 2 years ]
    t1/2

Biospecimen Retention: Samples With DNA
Dried blood spots for assessment of Hepatitis C genotype

Estimated Enrollment: 200
Study Start Date: November 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
Drug: Sofosbuvir 400 mg

These drugs are being offered as part of routine care

Other Name: Daclatasvir 60 mg
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.
Drug: Sofosbuvir 400 mg

These drugs are being offered as part of routine care

Other Name: Daclatasvir 60 mg

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Outpatients with hepatitis C attending the clinics of Medical Action Myanmar and the Myanmar Liver Foundation

Criteria

Inclusion Criteria:

    1. Age > 18- years, male or female
    2. Willing and able to comply with program assessment, including routine tests, attendance for follow up and compliance with medicine taking.
    3. Able to provide written agreement (or witnessed in the case of patients who cannot read and write)
    4. 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
  1. HIV well-controlled on current therapy (co-infected patients only)
  2. 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
  • Anaemia (Hb <100 mg/L)

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03158857

    Contacts

    Contact:   Elizabeth A Ashley, MB BS +959966421472 liz@tropmedres.ac
    Contact:   Htet Htet Aung, BA +959421108636 htethtetaung@mocru.org.mm

    Sponsors and Collaborators

    Myanmar Oxford Clinical Research Unit
    Myanmar Liver foundation (MLF)
    Medical Action Myanmar (MAM)

    Investigators

    Principal Investigator: Ni Ni Tun, MB BS Medical Action Myanmar; MOCRU
    Principal Investigator: Khin Pyone Kyi, MB BS Myanmar Liver Foundation
    More Information

    More Information


    Responsible Party: Myanmar Oxford Clinical Research Unit  
    ClinicalTrials.gov Identifier: NCT03158857   History of Changes  
    Other Study ID Numbers: OXTREC 3-17  
    Study First Received: May 16, 2017  
    Last Updated: August 30, 2017  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by Myanmar Oxford Clinical Research Unit:

    Myanmar
    HIV

    Additional relevant MeSH terms:
    Hepatitis
    Hepatitis A
    Hepatitis C
    Sofosbuvir

    ClinicalTrials.gov processed this data on December 12, 2017
    This information is provided by ClinicalTrials.gov.