Chronic Hepatitis CLIFE-CNCT02615145
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)
An observational study of Chronic Hepatitis C, run by AbbVie.
Trial summary
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well… 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
- 472 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2015to 26 Mar 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 patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with local label.
- If RBV is co-administered with the ABBVIE REGIMEN, 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 a patient authorization to use and/or disclose his/her pseudonymized health data prior to inclusion into the study
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Who cannot join
- Adolescents; people not treated according to label
About this study
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Dasabuvir, Ombitasvir+Paritaprevir+Ritonavir, Observational Study, Quality of life, Work-ability, Fibrosis, Cirrhosis
- 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 |
|---|---|---|
| Genotype 1a (G1a) Participants | Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. | |
| Genotype 1b (G1b) Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 [G4]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. | |
| Genotype 4 (G4) Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes 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 With Sustained Virologic Response (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.
Measured: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
Secondary outcomes (15)
Percentage of Participants With Virological Response at End of Treatment (EoTR)
Virological response is defined as HCV RNA < 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV.
Measured: EoT, (treatment period was 12 weeks or 24 weeks)
Number of Participants With On-Treatment Virological Failure or Relapse
The number of participants meeting the following SVR12 non-response categories:
- On-treatment virological failure (breakthrough) defined >= 1 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 participants who completed treatment (<= 7 days shortened).
Measured: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4.
Measured: Week 4
Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)
SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT.
Measured: 24 Weeks After EoT (treatment period was 12 or 24 weeks)
Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)
SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT.
Measured: 48 Weeks After EoT (treatment period was 12 or 24 weeks)
Change From Baseline in PRISM Over Time
PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the "self" (yellow disk) and the illness disk (red disk) is called "self-illness separation" (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering.
Measured: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection
Measured: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Percentage of Participants Taking ≥ 1 Co-Medication
Measured: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Mean Duration of of ABBVIE REGIMEN and RBV Taken
Documented by participant interview and/or participant diary.
Measured: Up to Week 12 or Week 24
Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
Planned duration of treatment was 12 or 24 weeks.
Measured: Up to Week 12 or Week 24
Change From Baseline in FACIT-F Scale Over Time
The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue.
Measured: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
Change From Baseline to EoT in PAM-13 Questionnaire
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence.
Measured: Baseline, EoT (treatment period was 12 or 24 weeks)
Change From Baseline Over Time in WPAI: Total Work Productivity 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 work productivity impairment indicates the percentage of overall work impairment due to health problems.
Measured: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Change From Baseline Over Time in 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 indicates the percentage of general (non-work) activity impairment due to health problems.
Measured: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing.
Measured: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start3 Dec 2015
- Primary completion26 Mar 2018
- Study completion26 Mar 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
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615145
- Sponsor's protocol ID
- P15-398
- Acronym
- LIFE-C
- Status last verified
- Jan 2019
- First submitted
- 24 Nov 2015
- Last updated
- 7 Oct 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 7 Oct 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 Germany (LIFE-C)
- ClinicalTrials.gov ID
- NCT02615145
- Acronym / sponsor ID
- LIFE-C / P15-398
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Dasabuvir, Ombitasvir+Paritaprevir+Ritonavir, Observational Study, Quality of life, Work-ability, Fibrosis, Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotype 1a (G1a) Participants | – | –Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
| Genotype 1b (G1b) Participants | – | –Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 [G4]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
| Genotype 4 (G4) Participants | – | –Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes 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 (4 listed)
- Treatment-naïve or -experienced patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with local label.
- If RBV is co-administered with the ABBVIE REGIMEN, 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 a patient authorization to use and/or disclose his/her pseudonymized health data prior to inclusion into the study
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Key exclusion criteria (1 listed)
- Adolescents; people not treated according to label
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 With Sustained Virologic Response (SVR12)
Time frame: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.
15 secondary outcomes
Percentage of Participants With Virological Response at End of Treatment (EoTR)
Time frame: EoT, (treatment period was 12 weeks or 24 weeks)
Number of Participants With On-Treatment Virological Failure or Relapse
Time frame: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
Time frame: Week 4
Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)
Time frame: 24 Weeks After EoT (treatment period was 12 or 24 weeks)
Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)
Time frame: 48 Weeks After EoT (treatment period was 12 or 24 weeks)
Change From Baseline in PRISM Over Time
Time frame: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection
Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Percentage of Participants Taking ≥ 1 Co-Medication
Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Mean Duration of of ABBVIE REGIMEN and RBV Taken
Time frame: Up to Week 12 or Week 24
Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
Time frame: Up to Week 12 or Week 24
Change From Baseline in FACIT-F Scale Over Time
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
Change From Baseline to EoT in PAM-13 Questionnaire
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks)
Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Change From Baseline Over Time in WPAI: Total Activity Impairment
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
Time frame: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 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 4 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 7 Oct 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 7 Oct 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 With Sustained Virologic Response (SVR12) (time frame: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)). 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 NCT02615145, 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 7 Oct 2019.