Hepatitis CSM2NCT04113629
Simplified Monitoring Myanmar SM2 Study
A study testing HCV point of care machine in people with Hepatitis C and Liver Cirrhoses, run by Kirby Institute at 1 site in Australia.
Trial summary
The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Liver Cirrhoses, Liver Inflammation
- What is being tested?
- HCV point of care machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Jan 2019to 22 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Subjects must meet all of the following inclusion criteria to participate in this study.
- Have voluntarily signed the consent form.
- 18 years of age or older.
- HCV antibody positive.
- HIV antibody positive.
Who cannot join
- Subjects who meet any of the exclusion criteria are not to be enrolled in this study.
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol.
- Creatinine clearance (CLcr) < 30mL/min at screening.
- Pregnant or nursing female.
- Use of prohibited concomitant medications.
- Inability or unwillingness to provide informed consent or abide by the study requirements.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Kirby Institute, University of New South Wales Australia
Sydney, New South Wales, 2052
About this study
Official title: Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
Read the detailed description
A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling.
In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.
They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.
Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.
The proportion of patients reaching SVR will be calculated.
- Conditions
- Hepatitis C, Liver Cirrhoses, Liver Inflammation, HIV Infections
- Being tested
- HCV point of care machine
- Medical subject headings
- Hepatitis C, Hepatitis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV point of care machineDevice
Xpert HCV Assay performed on the GeneXpert point of care machine
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir/Daclatasvir | Other | standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir Receives: Device: HCV point of care machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
Measured: 12 weeks post completion of commenced treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start22 Jan 2019
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- University of Public Health, Myanmar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113629
- Sponsor's protocol ID
- VHCRP1803
- Acronym
- SM2
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
- ClinicalTrials.gov ID
- NCT04113629
- Acronym / sponsor ID
- SM2 / VHCRP1803
- Conditions
- Hepatitis C, Liver Cirrhoses, Liver Inflammation, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- University of Public Health, Myanmar
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 3 Oct 2019 (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.
The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
Detailed description
A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling.
In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.
They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.
Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.
The proportion of patients reaching SVR will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir/Daclatasvir | Other | Device: HCV point of care machinestandard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must meet all of the following inclusion criteria to participate in this study.
- Have voluntarily signed the consent form.
- 18 years of age or older.
- HCV antibody positive.
- HIV antibody positive.
Key exclusion criteria (6 listed)
- Subjects who meet any of the exclusion criteria are not to be enrolled in this study.
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol.
- Creatinine clearance (CLcr) < 30mL/min at screening.
- Pregnant or nursing female.
- Use of prohibited concomitant medications.
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 |
|---|---|---|
| HCV point of care machineXpert HCV Assay performed on the GeneXpert point of care machine | Device | Sofosbuvir/Daclatasvir |
Primary outcome
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
Time frame: 12 weeks post completion of commenced treatment
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV point of care machine in people with Hepatitis C and Liver Cirrhoses, run by Kirby Institute at 1 site in Australia.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 21 Feb 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) (time frame: 12 weeks post completion of commenced treatment). 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 21 Feb 2021.