Hepatitis C, ChronicPhase 4ATTICNCT03797066
ATTIC - Access To Treat in the Community
A Phase 4 study testing ZEPATIER 50Mg-100Mg Tablet in people with Hepatitis C, Chronic, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The study is looking at the potential of utilizing a "point of care" test and treat pathway; using the DDA called Zepatier for achieving SVR in an homeless population who have tested positive for genotype 1 or 4 HCV. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- ZEPATIER 50Mg-100Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2019to 30 Nov 2020
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible.
- Able and wiling to provide written informed consent.
- Both interferon treatment naïve and experienced participants will be included.
- Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of ≤ 12.5.
- Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) will be eligible if the serum albumin is > 3.5 g/dl, platelets > 100,000 and INR < 1.5 and there is no prior history of hepatic decompensation.
- Participants with well controlled HIV coinfection will be included, but should be stabilized on antiretrovirals for which no clinically significant interaction is expected.
- Participants who are HBsAg positive will be included, but will require antiviral prophylaxis for HepB. Anti- HbC positive participants will be included. Prophylaxis will not be given, but these participants will require careful monitoring of their ALT levels.
Who cannot join
- Persons with prior HCV DAA treatment
- Individuals younger than 18 years of age
- Individuals infected with genotypes other than 1a or 1b or 4 HCV identified on screening; however such participants identified on screening will be offered appropriate NHS England standard of treatment for the genotype.
- Unable or unwilling to give informed consent
- Active tuberculosis
- Females who are pregnant, planning pregnancy or breastfeeding
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- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within three months of study enrolment
- Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past, present, or being evaluated, that may interfere with participant treatment, safety, assessment or compliance with the protocol
- Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) and serum albumin is < 3.5 g/dl, platelets <100,000 and INR > 1.5 or a prior history of hepatic decompensation
- Severe renal impairment with eGFR <30 mL/min/1.73m2 or requiring dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Localized on -Site Testing and Treatment of Hepatitis C in Homeless Persons in South London: a Pilot Non-randomised Phase 4 Interventional Clinical Trial of Grazoprevir and Elbasvir ± Ribavirin in Participants With Genotype 1a, 1b or 4 to Measure Efficacy and Adherence to Treatment in a Homeless Population
The study is looking at the potential of utilizing a "point of care" test and treat pathway; using the DDA called Zepatier for achieving SVR in an homeless population who have tested positive for genotype 1 or 4 HCV.
Read the detailed description
Direct acting antivirals (DAA) are new medications that have been approved for the management of HCV. These drugs have proven to be very effective in curing the HCV, without the need for interferon injections; which have always been used in the past. There are many combinations of DAAs, which treat specific types of HCV. Persons who test positive for the virus are typically referred to be seen and treated by a specialist hepatitis service based in hospital. This means that individuals may sometimes not attend the hospital to commence treatment; or follow up on their management.
The study is designed to explore if testing and treating individuals close to their own "local" setting will be an improvement to the current treatment pathway and encourage better involvement with the health care team; as well as looking at what the health care team can do to ensure participants in this test-and-treat trial receive the entire course of drug treatment prescribed to treat their HCV infection.
Participants infected with either genotype 1 or 4 HCV infection will be treated with Zepatier, a DAA which works by stopping the hepatitis C virus from (multiplying). The study medication is taken for 12 or 16 weeks depending on the genotype (or strain of HCV). Some participants will be given an additional drug called ribavirin. The study will examine the effectiveness of Zepatier at clearing the hepatitis C virus from the blood and body; and also what particular effects may be experienced by participants who may also be taking treatment for other conditions. Participants affected with other genotypes (not 1 and 4)will be offered standard NHS treatment with the appropriate antiviral combination for these strains.
- Conditions
- Hepatitis C, Chronic
- Being tested
- ZEPATIER 50Mg-100Mg Tablet
- Keywords
- hepatitis C virus, homeless
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEPATIER 50Mg-100Mg TabletDrug
Zepatier 50/100 OD , with addition of Ribavarin in patients with Genotype 1a and 4 with HCV RNA> 800,000 iu/ml or baseline NS5A resistance.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | A phase 4, open label, non-randomised study, conducted in hostels and homeless shelters in London; as well as mobile clinics in collaboration with the Hep C trust and the NHS Find and Treat program.
Treatment: 12 or 16 weeks of Zepatier, based on genotypes; with Ribavarin for certain subtypes. The study drug is administered as a single tablet; which is a combination of 100 mg of grazoprevir and 50 mg of elbasvir; as outlined below:
Genotypes 1a/b and 4: once daily dose for 12 weeks, taken with / without food. Genotype 1a and 4: (HCV RNA> 800,000 iu/ml or baseline NS5A resistance): once daily dose for 16 weeks, taken with / without food.
NO dose modifications with the study drug. Receives: Drug: ZEPATIER 50Mg-100Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR
The percentage of participants achieving an SVR, defined as an HCV RNA evel less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community.
Measured: 24 months
Secondary outcomes (6)
prevalence of HCV infection
Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels.
Measured: 24 months
Baseline knowledge evaluation
Participant knowledge of their hepatitis C status (disease, diagnosis, and current available approved treatments) will be assessed by means of a questionnaire completed at baseline. The researchers will also review participants willingness to engage in a test and treat protocol and correlate these findings with demographic and sociological data. This will be done using a questionnaire designed by the researchers; containing simple questions with respect to currently available testing and treatment of HCV infection.
Measured: 24 months
Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. The survey addresses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL.
Data will be analysed ffg the guidelines suggested by the developers https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html
Measured: baseline, SVR 12 (twelve weeks post end of active treatment/ last dose of study drug)
Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
Impact of a localized test and treat protocol on health related quality of life will be assessed using the CLDQ-HCV instruments. The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life
Measured: baseline , SVR 12 (twelve weeks post end of active treatment/last dose of study drug)
Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis)
Adherence to treatment measured by Moriskey, Green and Levine Adherence scale. This is a 4 item questionnaire that is easy to administer and score (using a yes/no format); and quickly identifies barriers to adherence.An answer of yes to zero questions indicates high adherence behavior, answering yes to one or two questions indicates medium adherence behavior, and answering yes to three or four questions indicates low adherence behavior
Measured: 12 or 16 weeks
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
Compliance will be calculated as the amount of dispensed medication minus the amount of medication returned by participants at each visit.
Measured: 12 or 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start23 Mar 2019
- Primary completion28 Jul 2020
- Study completion30 Nov 2020
Why it stopped: Changing parameters in HCV management, resulted in poor recruitment; additionally onset of SARS CoV2 resulted in the cessation of all mobile clinical services.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomised, open label
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hepatitis C Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797066
- Sponsor's protocol ID
- KCHATTIC01
- Acronym
- ATTIC
- Status last verified
- May 2023
- First submitted
- 30 Oct 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymised data sharing only, via publications
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized on -Site Testing and Treatment of Hepatitis C in Homeless Persons in South London: a Pilot Non-randomised Phase 4 Interventional Clinical Trial of Grazoprevir and Elbasvir ± Ribavirin in Participants With Genotype 1a, 1b or 4 to Measure Efficacy and Adherence to Treatment in a Homeless Population
- ClinicalTrials.gov ID
- NCT03797066
- Acronym / sponsor ID
- ATTIC / KCHATTIC01
- Conditions
- Hepatitis C, Chronic
- Keywords
- hepatitis C virus, homeless
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changing parameters in HCV management, resulted in poor recruitment; additionally onset of SARS CoV2 resulted in the cessation of all mobile clinical services.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hepatitis C Trust
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 8 Jan 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 is looking at the potential of utilizing a "point of care" test and treat pathway; using the DDA called Zepatier for achieving SVR in an homeless population who have tested positive for genotype 1 or 4 HCV.
Detailed description
Direct acting antivirals (DAA) are new medications that have been approved for the management of HCV. These drugs have proven to be very effective in curing the HCV, without the need for interferon injections; which have always been used in the past. There are many combinations of DAAs, which treat specific types of HCV. Persons who test positive for the virus are typically referred to be seen and treated by a specialist hepatitis service based in hospital. This means that individuals may sometimes not attend the hospital to commence treatment; or follow up on their management.
The study is designed to explore if testing and treating individuals close to their own "local" setting will be an improvement to the current treatment pathway and encourage better involvement with the health care team; as well as looking at what the health care team can do to ensure participants in this test-and-treat trial receive the entire course of drug treatment prescribed to treat their HCV infection.
Participants infected with either genotype 1 or 4 HCV infection will be treated with Zepatier, a DAA which works by stopping the hepatitis C virus from (multiplying). The study medication is taken for 12 or 16 weeks depending on the genotype (or strain of HCV). Some participants will be given an additional drug called ribavirin. The study will examine the effectiveness of Zepatier at clearing the hepatitis C virus from the blood and body; and also what particular effects may be experienced by participants who may also be taking treatment for other conditions. Participants affected with other genotypes (not 1 and 4)will be offered standard NHS treatment with the appropriate antiviral combination for these strains.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomised, open label
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: ZEPATIER 50Mg-100Mg TabletA phase 4, open label, non-randomised study, conducted in hostels and homeless shelters in London; as well as mobile clinics in collaboration with the Hep C trust and the NHS Find and Treat program. Treatment: 12 or 16 weeks of Zepatier, based on genotypes; with Ribavarin for certain subtypes. The study drug is administered as a single tablet; which is a combination of 100 mg of grazoprevir and 50 mg of elbasvir; as outlined below: Genotypes 1a/b and 4: once daily dose for 12 weeks, taken with / without food. Genotype 1a and 4: (HCV RNA> 800,000 iu/ml or baseline NS5A resistance): once daily dose for 16 weeks, taken with / without food. NO dose modifications with the study drug. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible.
- Able and wiling to provide written informed consent.
- Both interferon treatment naïve and experienced participants will be included.
- Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of ≤ 12.5.
- Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) will be eligible if the serum albumin is > 3.5 g/dl, platelets > 100,000 and INR < 1.5 and there is no prior history of hepatic decompensation.
Key exclusion criteria (10 listed)
- Persons with prior HCV DAA treatment
- Individuals younger than 18 years of age
- Individuals infected with genotypes other than 1a or 1b or 4 HCV identified on screening; however such participants identified on screening will be offered appropriate NHS England standard of treatment for the genotype.
- Unable or unwilling to give informed consent
- Active tuberculosis
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 |
|---|---|---|
| ZEPATIER 50Mg-100Mg TabletZepatier 50/100 OD , with addition of Ribavarin in patients with Genotype 1a and 4 with HCV RNA> 800,000 iu/ml or baseline NS5A resistance. | Drug | Single arm |
Primary outcome
SVR
Time frame: 24 months
The percentage of participants achieving an SVR, defined as an HCV RNA evel less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community.
6 secondary outcomes
prevalence of HCV infection
Time frame: 24 months
Baseline knowledge evaluation
Time frame: 24 months
Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores
Time frame: baseline, SVR 12 (twelve weeks post end of active treatment/ last dose of study drug)
Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
Time frame: baseline , SVR 12 (twelve weeks post end of active treatment/last dose of study drug)
Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis)
Time frame: 12 or 16 weeks
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
Time frame: 12 or 16 weeks
Results and safety
The study was stopped early (reason given: Changing parameters in HCV management, resulted in poor recruitment; additionally onset of SARS CoV2 resulted in the cessation of all mobile clinical services.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No. anonymised data sharing only, via publications
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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 Phase 4 study testing ZEPATIER 50Mg-100Mg Tablet in people with Hepatitis C, Chronic, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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: stopped early, as of the sponsor's last update on 6 May 2023. 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 United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Changing parameters in HCV management, resulted in poor recruitment; additionally onset of SARS CoV2 resulted in the cessation of all mobile clinical services.). Results are not available in the source record.
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?
SVR (time frame: 24 months). 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 6 May 2023.