Hepatitis C, ChronicPhase 3SMART-CNCT03117569
Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
A Phase 3 study testing glecaprevir (300mg)/pibrentasvir (120mg) in people with Hepatitis C, Chronic, run by Kirby Institute at 33 sites in 8 countries.
Trial summary
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified. Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- glecaprevir (300mg)/pibrentasvir (120mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 33 sitesin 8 countries
- Study dates
- 21 Aug 2017to 19 Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have voluntarily signed the informed consent form.
- 18 years of age or older.
- Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- HCV RNA plasma ≥ 10,000 IU/ml at screening.
- HCV genotype 1-6.
- HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
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- Stage F0-3, based on: hepatic elastography <12.5 kPa on Fibroscan® or APRI <1.0.
- If co-infection with HIV is documented, the subject must meet the following criteria:
- ART naïve with CD4 T cell count >500 cells/mm3; OR
- On a stable ART regimen (containing only permissible ART - see protocol section 3.2) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
- Negative pregnancy test at screening and baseline (females of childbearing potential only).
- All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.
Who cannot join
- History of any of the following:
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
- Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
- Solid organ transplant.
- History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
- Any of the following lab parameters at screening:
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- ALT > 10 x ULN
- AST > 10 x ULN
- Direct bilirubin > ULN
- Platelets < 90,000/μL (cells/mm3) if Fibroscan® <12.5 kPa OR < 150,000/μL (cells/mm3) if Fibroscan® is unavailable and patient is included with APRI <1
- Creatinine clearance (CLcr) < 50 mL/min
- Haemoglobin < 12g/dL for males; <11g/dL for females
- Albumin < LLN
- INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
- Pregnant or breastfeeding female.
- HBV infection (HBsAg positive).
- Use of prohibited concomitant medications as described in protocol section 5.2.
- Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).
- Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.
- Any investigational drug ≤6 weeks prior to the first dose of study drug.
- Ongoing severe psychiatric disease as judged by the treating physician.
- Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, propoxyphene, or alcohol, with the exception of a positive result (including methadone) associated with documented short-term use or chronic stable use of a prescribed medication in that class.
- Injecting drug use within the previous six months.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Trial locations and contacts
33 sites in 8 countries.
33 sites in 8 countries
Canada7 sites
William Osler Health System
Brampton, Ontario, L6R 3J7
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
Toronto General Hospital
Toronto, Ontario, ON M57 2S8
Lair Centre
Vancouver, British Columbia, V5Z 1H2
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Australia6 sites
Royal Adelaide Hospital
Adelaide, South Australia
The Alfred Hospital
Melbourne, Victoria, 3004
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
East Sydney Doctors
Sydney, New South Wales, 2010
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
Holdsworth House Medical Practice
Sydney, New South Wales
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Duke University Medical Center
Durham, North Carolina, 27710
SSM Health Dean Medical Group
Madison, Wisconsin, 53715
New York University Langone Medical Center
New York, New York, 10016
Germany4 sites
zibp - Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, 10439
Center for HIV and Hepatogastroenterology
Düsseldorf, 40237
Hannover Medical School
Hanover, 30625
CIM-Centrum fuer Interdisziplinaere Medizin GmbH
Münster, 48143
New Zealand4 sites
Auckland City Hospital
Auckland, 1142
Calder Center
Auckland
Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
France3 sites
Hopital Henri Mondor
Créteil, 94000
Hopital Saint Joseph
Marseille, 13008
Hopital Saint Antoine
Paris, 75012
United Kingdom3 sites
Barts Health
London, E1 1BB
King's College Hospital
London, SE5 9RS
Imperial College Healthcare NHS Trust (St Mary's Hospital)
London, W2 1NY
Switzerland2 sites
Inselspital - Universitaetsspital Bern
Bern, 3010
University Hospital Zurich
Zurich, 8091
About this study
Official title: A Phase IIIb, Open-label, Multicentre, International Randomised Controlled Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir (300mg)/Pibrentasvir (120mg) in Chronic HCV Treatment naïve Patients Without Cirrhosis
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.
Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.
Read more
Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.
One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).
Read the detailed description
The capacity to scale-up interferon-free DAA therapy would be enhanced by simplified treatment monitoring strategies. The "next generation" DAA regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor, provides key features for HCV treatment simplification, including on-treatment monitoring: 1) pangenotypic activity with extremely high efficacy (SVR>95%); 2) no relationship between time to undetectable HCV RNA and SVR; 3) minimal drug-related toxicity; 4) ease of dosing (three pills once daily); and short duration (8 weeks in non-cirrhosis and 12 weeks in cirrhosis for treatment naïve patients). In phase II and III clinical trials in participants without cirrhosis, 8 weeks of glecaprevir (300mg)/pibrentasvir (120mg) has provided intention-to-treat SVR rates of 99.1%, 98%, 97%, and 93.1% in genotype 1, 2, 3, and 4-6 populations, respectively.
Current standard on-treatment monitoring in clinical trials involves clinic-based visits every 4 weeks. In the DAA era where treatments are highly tolerable, effective and short duration, this intensive monitoring strategy may no longer be required. A simplified on-treatment monitoring strategy is hypothesised to be non-inferior to the standard clinical trial on treatment monitoring strategy. If successful, a simplified on-treatment monitoring strategy is likely to be highly attractive to patients, clinicians and health care payers. It has the potential to improve the rapid scale up of treatment providing population level benefits in the reduction of global hepatitis C disease burden.
This study will be conducted as a Phase IIIb, randomised, controlled, multicentre, international trial.
There will be a maximum screening period of 6 weeks prior to Baseline. Eligible patients will be randomised into one of two on-treatment monitoring strategies; standard clinical trial monitoring (4-weekly on-treatment visits) vs simplified monitoring (no on-treatment visits). Randomisation will be 1:2 (standard vs simplified) and all participants will receive treatment with glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks.
All participants will attend the clinic for screening and baseline visit. Randomisation will occur at the baseline visit.
The two on-treatment monitoring strategies will differ as follows:
- Standard monitoring arm participants will have on-treatment clinic visits at weeks 4 and 8 (EoT).
- Simplified monitoring arm participants will have no on-treatment clinic visits.
Study nurse phone contact will also be made to participants in BOTH arms 1-2 days prior Week 4 and EoT (Week 8) visits to provide standardized reporting of adverse events, concomitant medication and adherence. One post treatment clinic visit will be conducted at SVR12 (week 20) for all participants.
- Conditions
- Hepatitis C, Chronic
- Being tested
- glecaprevir (300mg)/pibrentasvir (120mg)
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glecaprevir (300mg)/pibrentasvir (120mg)Drug
Also called Mavyret
glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard monitoring schedule | Other | Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits). Receives: Drug: glecaprevir (300mg)/pibrentasvir (120mg) |
| Simplified monitoring schedule | Experimental | Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8. Receives: Drug: glecaprevir (300mg)/pibrentasvir (120mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA (ITT Population)
Number of participants with undetectable HCV RNA based on ITT population.
Measured: 12 weeks post end of treatment (SVR12)
Secondary outcomes (5)
Undetectable HCV RNA (mITT Population)
Number of participants with undetectable HCV RNA based on mITT population.
Measured: 12 weeks post end of treatment (SVR12)
Treatment and Study Visits Adherence
Number adherent to treatment and study visits (on-treatment adherence and early treatment discontinuation).
Measured: 12 weeks post end of treatment (SVR12)
Health-related Quality of Life
Change in health-related quality of life score pre and post-treatment (measured by EQ-5D-3L). The EQ visual analogue scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (value of 100) and 'Worst imaginable health state' (value of 0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. Higher scores indicate better outcomes.
Measured: Screening and 12 weeks post end of treatment (SVR12)
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
Distribution of baseline resistance associated substitutions (RAS) in participants with virological failures. Baseline polymorphisms were detected by Sanger sequencing at the following amino acid positions:
NS3: 36, 56, 80, 155, 156, 166, 168 NS5A: 24, 28, 30, 31, 58, 93
Measured: Baseline and 12 weeks post-treatment
Patient Treatment Satisfaction
Patient was satisfied with their treatment follow-up plan.
Measured: 12 weeks post end of treatment (SVR12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start21 Aug 2017
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gregory Dore, Principal investigator, Kirby Institute, University of New South Wales Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117569
- Sponsor's protocol ID
- VHCRP1701
- Acronym
- SMART-C
- Status last verified
- Dec 2019
- First submitted
- 7 Apr 2017
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: No individual participant data will be shared. The results of the project will be presented at scientific meetings, and published in peer reviewed scientific literature. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We plan to make our results available to the community of scientists interested in recently acquired hepatitis C, community organisations representing the affected communities and participants. We also welcome collaboration with others who could make use of data and samples.
Publications
Dore GJ, Feld JJ, Thompson A, Martinello M, Muir AJ, Agarwal K, Mullhaupt B, Wedemeyer H, Lacombe K, Matthews GV, Schultz M, Klein M, Hezode C, Mercade GE, Kho D, Petoumenos K, Marks P, Tatsch F, Dos Santos AGP, Gane E; SMART-C Study Group. Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial. J Hepatol. 2020 Mar;72(3):431-440. doi: 10.1016/j.jhep.2019.10.010. Epub 2019 Oct 23.
PubMed 31655134
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Open-label, Multicentre, International Randomised Controlled Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir (300mg)/Pibrentasvir (120mg) in Chronic HCV Treatment naïve Patients Without Cirrhosis
- ClinicalTrials.gov ID
- NCT03117569
- Acronym / sponsor ID
- SMART-C / VHCRP1701
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.
Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.
Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.
One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).
Detailed description
The capacity to scale-up interferon-free DAA therapy would be enhanced by simplified treatment monitoring strategies. The "next generation" DAA regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor, provides key features for HCV treatment simplification, including on-treatment monitoring: 1) pangenotypic activity with extremely high efficacy (SVR>95%); 2) no relationship between time to undetectable HCV RNA and SVR; 3) minimal drug-related toxicity; 4) ease of dosing (three pills once daily); and short duration (8 weeks in non-cirrhosis and 12 weeks in cirrhosis for treatment naïve patients). In phase II and III clinical trials in participants without cirrhosis, 8 weeks of glecaprevir (300mg)/pibrentasvir (120mg) has provided intention-to-treat SVR rates of 99.1%, 98%, 97%, and 93.1% in genotype 1, 2, 3, and 4-6 populations, respectively.
Current standard on-treatment monitoring in clinical trials involves clinic-based visits every 4 weeks. In the DAA era where treatments are highly tolerable, effective and short duration, this intensive monitoring strategy may no longer be required. A simplified on-treatment monitoring strategy is hypothesised to be non-inferior to the standard clinical trial on treatment monitoring strategy. If successful, a simplified on-treatment monitoring strategy is likely to be highly attractive to patients, clinicians and health care payers. It has the potential to improve the rapid scale up of treatment providing population level benefits in the reduction of global hepatitis C disease burden.
This study will be conducted as a Phase IIIb, randomised, controlled, multicentre, international trial.
There will be a maximum screening period of 6 weeks prior to Baseline. Eligible patients will be randomised into one of two on-treatment monitoring strategies; standard clinical trial monitoring (4-weekly on-treatment visits) vs simplified monitoring (no on-treatment visits). Randomisation will be 1:2 (standard vs simplified) and all participants will receive treatment with glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks.
All participants will attend the clinic for screening and baseline visit. Randomisation will occur at the baseline visit.
The two on-treatment monitoring strategies will differ as follows:
- Standard monitoring arm participants will have on-treatment clinic visits at weeks 4 and 8 (EoT).
- Simplified monitoring arm participants will have no on-treatment clinic visits.
Study nurse phone contact will also be made to participants in BOTH arms 1-2 days prior Week 4 and EoT (Week 8) visits to provide standardized reporting of adverse events, concomitant medication and adherence. One post treatment clinic visit will be conducted at SVR12 (week 20) for all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard monitoring schedule | Other | Drug: glecaprevir (300mg)/pibrentasvir (120mg)Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits). |
| Simplified monitoring schedule | Experimental | Drug: glecaprevir (300mg)/pibrentasvir (120mg)Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have voluntarily signed the informed consent form.
- 18 years of age or older.
- Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- HCV RNA plasma ≥ 10,000 IU/ml at screening.
- HCV genotype 1-6.
Key exclusion criteria (24 listed)
- History of any of the following:
- Any of the following lab parameters at screening:
- Pregnant or breastfeeding female.
- HBV infection (HBsAg positive).
- Use of prohibited concomitant medications as described in protocol section 5.2.
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 |
|---|---|---|
| glecaprevir (300mg)/pibrentasvir (120mg)Also: Mavyretglecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks | Drug | Simplified monitoring schedule, Standard monitoring schedule |
Primary outcome
Undetectable HCV RNA (ITT Population)
Time frame: 12 weeks post end of treatment (SVR12)
Number of participants with undetectable HCV RNA based on ITT population.
5 secondary outcomes
Undetectable HCV RNA (mITT Population)
Time frame: 12 weeks post end of treatment (SVR12)
Treatment and Study Visits Adherence
Time frame: 12 weeks post end of treatment (SVR12)
Health-related Quality of Life
Time frame: Screening and 12 weeks post end of treatment (SVR12)
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
Time frame: Baseline and 12 weeks post-treatment
Patient Treatment Satisfaction
Time frame: 12 weeks post end of treatment (SVR12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31655134Dore GJ, Feld JJ, Thompson A, Martinello M, Muir AJ, Agarwal K, Mullhaupt B, Wedemeyer H, Lacombe K, Matthews GV, Schultz M, Klein M, Hezode C, Mercade GE, Kho D, Petoumenos K, Marks P, Tatsch F, Dos Santos AGP, Gane E; SMART-C Study Group. Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial. J Hepatol. 2020 Mar;72(3):431-440. doi: 10.1016/j.jhep.2019.10.010. Epub 2019 Oct 23.
- Individual participant dataSharing planned: Yes. No individual participant data will be shared. The results of the project will be presented at scientific meetings, and published in peer reviewed scientific literature. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We plan to make our results available to the community of scientists interested in recently acquired hepatitis C, community organisations representing the affected communities and participants. We also welcome collaboration with others who could make use of data and samples.
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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.
Gregory Dore principal investigator
Kirby Institute, University of New South Wales Sydney, Australia
33 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glecaprevir (300mg)/pibrentasvir (120mg) in people with Hepatitis C, Chronic, run by Kirby Institute at 33 sites in 8 countries.
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 12 inclusion and 24 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Canada, Australia, United States, Germany, New Zealand and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Undetectable HCV RNA (ITT Population) (time frame: 12 weeks post end of treatment (SVR12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117569, which also lists 1 linked publication.
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 11 Dec 2019.