Hepatitis C Treatment Study in Myanmar

NCT03158857 | Withdrawn

• 1 other identifier: OXTREC 3-17
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Keywords

Myanmar; HIV

Outcome Measures

Primary Outcomes (1)

• SVR12

  Sustained Virological Response 12 weeks after completion of therapy

  12 weeks

Secondary Outcomes (1)

• AEs

  12-24 weeks

Other Outcomes (3)

• Maximum plasma concentration

  2 years

• Area under the curve

  2 years

• Elimination half-life

  2 years

Study Arms (2)

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

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

Interventions

Sofosbuvir 400 mg DRUG

These drugs are being offered as part of routine care

Also known as: Daclatasvir 60 mg

Hepatitis C and HIV co-infection; Hepatitis C monoinfection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• \. Anaemia (Hb \<100 mg/L)

Sponsors & Collaborators

• Myanmar Oxford Clinical Research Unit: lead
• Myanmar Liver Foundation: collaborator
• Medical Action Myanmar: collaborator

Study Sites (1)

Medical Action Myanmar

Yangon, Burma

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots for assessment of Hepatitis C genotype

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ni Ni Tun, MB BS

  Medical Action Myanmar; MOCRU

  PRINCIPAL INVESTIGATOR

• Khin Pyone Kyi, MB BS

  Myanmar Liver Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 17, 2021

Record last verified: 2020-02

Locations

BU (1)