Hepatitis CNCT03158857
Hepatitis C Treatment Study in Myanmar
An observational study of Hepatitis C, run by Myanmar Oxford Clinical Research Unit at 1 site in Burma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir 400 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteBurma
- Study dates
- Jan 2022to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with hepatitis C attending the clinics of Medical Action Myanmar and the Myanmar Liver Foundation
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir 400 mg
- Keywords
- Myanmar, HIV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir 400 mgDrug
Also called Daclatasvir 60 mg
These drugs are being offered as part of routine care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sofosbuvir 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
Sustained Virological Response 12 weeks after completion of therapy
Measured: 12 weeks
Secondary outcomes (1)
AEs
Frequency of adverse events
Measured: 12-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startJan 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Long local IRB process to meet with the treatment deadline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myanmar Oxford Clinical Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Myanmar Liver Foundation, Medical Action Myanmar
- Responsible party
- Sponsor
- Investigators
- Ni Ni Tun, MB BS, Principal investigator, Medical Action Myanmar; MOCRUKhin Pyone Kyi, MB BS, Principal investigator, Myanmar Liver Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158857
- Sponsor's protocol ID
- OXTREC 3-17
- Status last verified
- Feb 2020
- First submitted
- 16 May 2017
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03158857
- Acronym / sponsor ID
- OXTREC 3-17
- Conditions
- Hepatitis C
- Keywords
- Myanmar, HIV
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Long local IRB process to meet with the treatment deadline
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Myanmar Oxford Clinical Research UnitUniversity, hospital or other
- Collaborators
- Myanmar Liver Foundation, Medical Action Myanmar
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C monoinfection | – | Drug: Sofosbuvir 400 mgSofosbuvir 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. |
| Hepatitis C and HIV co-infection | – | Drug: Sofosbuvir 400 mgSofosbuvir 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with hepatitis C attending the clinics of Medical Action Myanmar and the Myanmar Liver Foundation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir 400 mgAlso: Daclatasvir 60 mgThese drugs are being offered as part of routine care | Drug | Hepatitis C and HIV co-infection, Hepatitis C monoinfection |
Primary outcome
SVR12
Time frame: 12 weeks
Sustained Virological Response 12 weeks after completion of therapy
1 secondary outcome
AEs
Time frame: 12-24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ni Ni Tun, MB BS principal investigator
Medical Action Myanmar; MOCRU
Khin Pyone Kyi, MB BS principal investigator
Myanmar Liver Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Myanmar Oxford Clinical Research Unit at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.