Chronic Hepatitis CVERITASNCT02636608
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary
An observational study of Chronic Hepatitis C, run by AbbVie.
Trial summary
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2015to 23 May 2018
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Hepatitis C (CHC)
Who may be able to join
- Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
- If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Patients must voluntarily sign and date Subject Information Form and Informed Consent Form prior to inclusion into the study.
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
- Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.
Who cannot join
- None
About this study
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Dasabuvir, Paritaprevir/r/Ombitasvir, Observational Study, Quality of Life, Fibrosis, Cirrhosis, Work Ability
- Medical subject headings
- Hepatitis C, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
Measured: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary outcomes (20)
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.
The Core population with sufficient follow-up data regarding SVR24 included all core population participants who
- had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN
- or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline
- or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.
Measured: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
Percentage of Participants Achieving Virological Response at End of Treatment
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
Measured: End of treatment (week 12 or 24 depending on the treatment regimen)
Percentage of Participants With Relapse
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
Measured: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Number of Participants With Breakthrough
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Measured: 12 or 24 weeks (depending on the treatment regimen)
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
SVR12 non-response was categorized according to the following:
- On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);
- Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);
- Death;
- Premature treatment discontinuation with no on-treatment virologic failure;
- None of the above criteria or missing SVR12 data
Measured: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:
Cumulative dose taken / (initial prescribed dose * planned duration) * 100
The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.
Measured: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
Percentage of Participants With Adherence to Ribavirin by Adherence Category
Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:
Cumulative dose taken / (initial prescribed dose * planned duration) * 100
Measured: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
Measured: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
Number of Participants Who Received Concomitant Medications
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.
Measured: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Measured: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).
The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status.
Measured: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).
Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.
Measured: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.
Absenteeism indicates the percentage of work time missed due to health problems.
Measured: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.
Presenteeism indicates the percentage of impairment while working due to health problems.
Measured: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.
Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems.
Measured: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.
Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.
Measured: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Patient Activation Measure 13 (PAM-13)
PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health.
Measured: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)
Measured: Up to post treatment week 24
Utilization of the AbbVie Patient Support Program (PSP) Components
At the end of treatment visit participants were asked to indicate which of the following PSP services they had used:
- Personal support (e.g., Care Coach)
- Printed educational material
- Online educational materials
- Web-portal
- App
Measured: End of treatment (week 12 or 24 depending on the treatment regimen)
Satisfaction With the AbbVie Patient Support Program (PSP) Components
At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used.
Measured: End of treatment (weeks 12 or 24 depending on treatment regimen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start27 Nov 2015
- Primary completion23 May 2018
- Study completion23 May 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 Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IST GmbH, Germany
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636608
- Sponsor's protocol ID
- P15-709
- Other IDs
- HU15-01
- Acronym
- VERITAS
- Status last verified
- Jan 2019
- First submitted
- 16 Dec 2015
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
PubMed 30739368
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS
- ClinicalTrials.gov ID
- NCT02636608
- Acronym / sponsor ID
- VERITAS / P15-709
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Dasabuvir, Paritaprevir/r/Ombitasvir, Observational Study, Quality of Life, Fibrosis, Cirrhosis, Work Ability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- IST GmbH, Germany
- Study start
- 27 Nov 2015 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | – | –Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Hepatitis C (CHC)
Key inclusion criteria (5 listed)
- Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
- If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Patients must voluntarily sign and date Subject Information Form and Informed Consent Form prior to inclusion into the study.
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
- Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
20 secondary outcomes
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
Time frame: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
Percentage of Participants Achieving Virological Response at End of Treatment
Time frame: End of treatment (week 12 or 24 depending on the treatment regimen)
Percentage of Participants With Relapse
Time frame: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Number of Participants With Breakthrough
Time frame: 12 or 24 weeks (depending on the treatment regimen)
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
Percentage of Participants With Adherence to Ribavirin by Adherence Category
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
Number of Participants Who Received Concomitant Medications
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Time frame: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Change From Baseline in Patient Activation Measure 13 (PAM-13)
Time frame: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)
Time frame: Up to post treatment week 24
Utilization of the AbbVie Patient Support Program (PSP) Components
Time frame: End of treatment (week 12 or 24 depending on the treatment regimen)
Satisfaction With the AbbVie Patient Support Program (PSP) Components
Time frame: End of treatment (weeks 12 or 24 depending on treatment regimen)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30739368Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by AbbVie.
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 1 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 26 Jul 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?
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)). 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 NCT02636608, 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 26 Jul 2019.