NCT02615145 (LIFE-C) is a clinical trial in Chronic Hepatitis C, sponsored by AbbVie.

Who is sponsoring NCT02615145?

NCT02615145 is sponsored by AbbVie.

What condition does NCT02615145 study?

NCT02615145 studies Chronic Hepatitis C.

Is NCT02615145 still recruiting?

NCT02615145 is currently completed. Last updated 7 October 2019.

Are results published for NCT02615145?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-07 · How we verify

NCT02615145: LIFE-C

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Results posted Last updated 7 October 2019

What this trial tests

trial in Chronic Hepatitis C in 472 participants. Completed in 26 March 2018.

Timeline

3 December 2015

Primary endpoint
26 March 2018

26 March 2018

Quick facts

Lead sponsor	AbbVie
Status	Completed
Study type	OBSERVATIONAL
Enrollment	472
Start date	3 December 2015
Primary completion	26 March 2018
Estimated completion	26 March 2018

Conditions studied

Chronic Hepatitis C — all drugs for Chronic Hepatitis C →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 99, any sex, with Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Sustained Virologic Response (SVR12) Primary · 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.

Group	Value	95% CI
All Participants	88.1
All Genotype 1 Participants	88.4
Genotype 1a Participants	77.9
Genotype 1b Participants	93.9
Genotype 4 Participants	85.1

Percentage of Participants With Virological Response at End of Treatment (EoTR) Secondary · EoT, (treatment period was 12 weeks or 24 weeks)

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.

Group	Value	95% CI
All Participants	93.4
All Genotype 1 Participants	94.8
Genotype 1a Participants	89.0
Genotype 1b Participants	97.8
Genotype 4 Participants	80.9

Number of Participants With On-Treatment Virological Failure or Relapse Secondary · Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)

The number of participants meeting the following SVR12 non-response categories: 1. 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) 2. 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).

On-Treatment Virological Failure

Group	Value	95% CI
All Participants	6
All Genotype 1 Participants	3
Genotype 1a Participants	3
Genotype 1b Participants	0
Genotype 4 Participants	3

Relapse

Group	Value	95% CI
All Participants	5
All Genotype 1 Participants	5
Genotype 1a Participants	1
Genotype 1b Participants	4
Genotype 4 Participants	0

Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) Secondary · Week 4

RVR4 is defined as participants with HCV RNA \< 50 IU/mL at Week 4.

Group	Value	95% CI
All Participants	57.0
All Genotype 1 Participants	57.2
Genotype 1a Participants	62.1
Genotype 1b Participants	54.7
Genotype 4 Participants	55.3

Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) Secondary · 24 Weeks After EoT (treatment period was 12 or 24 weeks)

SVR24 is defined as HCV RNA \< 50 IU/mL 24 Weeks After EoT.

Group	Value	95% CI
All Participants	95.0
All Genotype 1 Participants	95.4
Genotype 1a Participants	92.8
Genotype 1b Participants	96.5
Genotype 4 Participants	91.9

Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) Secondary · 48 Weeks After EoT (treatment period was 12 or 24 weeks)

SVR48 is defined as participants with HCV RNA \< 50 IU/mL 48 weeks after EoT.

Group	Value	95% CI
All Participants	92.7
Genotype 1 Participants	93.2
Genotype 1a Participants	89.0
Genotype 1b Participants	95.1
Genotype 4 Participants	88.0

Change From Baseline in PRISM Over Time Secondary · Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)

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.

12 Weeks EoT

Group	Value	95% CI
2 DAA+RBV	5.41	2.67 – 8.15
3DAA	7.05	6.04 – 8.05
3DAA+RBV	5.31	3.91 – 6.71

48 Weeks EoT

Group	Value	95% CI
2 DAA+RBV	10.2	7.16 – 13.2
3DAA	10.1	8.93 – 11.2
3DAA+RBV	10.3	8.75 – 11.8

Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection Secondary · up to post-treatment Week 48 (treatment period was 12 or 24 weeks)

Group	Value	95% CI
All Participants	70.0
Genotype 1 Participants	69.3
Genotype 1a Participants	71.0
Genotype 1b Participants	68.3
Genotype 4 Participants	76.6

Percentage of Participants Taking ≥ 1 Co-Medication Secondary · up to post-treatment Week 48 (treatment period was 12 or 24 weeks)

Group	Value	95% CI
Total	59.1
2 DAA+RBV	64.4
3DAA	54.1
3DAA+RBV	66.0

Mean Duration of of ABBVIE REGIMEN and RBV Taken Secondary · Up to Week 12 or Week 24

Documented by participant interview and/or participant diary.

ABBVIE REGIMEN

Group	Value	95% CI
Total	83	± 11.7
2 DAA+RBV	84	± 3.4
3DAA	83	± 9.7
3DAA+RBV	84	± 15.6

RBV

Group	Value	95% CI
Total	81	± 18.1
2 DAA+RBV	84	± 3.4
3DAA+RBV	81	± 20.5

Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken Secondary · Up to Week 12 or Week 24

Planned duration of treatment was 12 or 24 weeks.

ABBVIE REGIMEN

Group	Value	95% CI
All Participants	98.7	± 9.74
All Genotype 1 Participants	98.6	± 10.18
Genotype 1a Participants	97.7	± 12.94
Genotype 1b Participants	99.1	± 8.39
Genotype 4 Participants	99.8	± 3.91

RBV

Group	Value	95% CI
All Participants	95.4	± 17.55
All Genotype 1 Participants	94.1	± 19.72
Genotype 1a Participants	95.3	± 17.68
Genotype 1b Participants	83.5	± 30.68
Genotype 4 Participants	99.8	± 3.91

Change From Baseline in FACIT-F Scale Over Time Secondary · Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT

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.

EoT

Group	Value	95% CI
2 DAA+RBV	4.17	-2.35 – 10.7
3DAA	6.45	4.05 – 8.86
3DAA+RBV	4.49	1.17 – 7.81

12 Weeks EoT

Group	Value	95% CI
2 DAA+RBV	12.5	6.78 – 18.3
3DAA	9.92	7.87 – 12.0
3DAA+RBV	10.2	7.37 – 13.0

48 Weeks EoT

Group	Value	95% CI
2 DAA+RBV	13.3	4.71 – 22.0
3DAA	9.68	6.87 – 12.5
3DAA+RBV	10.3	6.37 – 14.3

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2 DAA+RBV

Serious: 1/45 (2%)

Deaths: 0/45

3DAA

Serious: 7/266 (3%)

Deaths: 4/266

3DAA+RBV

Serious: 5/159 (3%)

Deaths: 1/159

Serious adverse events (12 terms)

Reaction	System	2 DAA+RBV	3DAA	3DAA+RBV
ANAEMIA	Blood and lymphatic system disorders	—	—	—
GASTRIC PERFORATION	Gastrointestinal disorders	—	—	—
DEATH	General disorders	—	—	—
HEPATIC CIRRHOSIS	Hepatobiliary disorders	—	—	—
OROPHARYNGEAL CANDIDIASIS	Infections and infestations	—	—	—
SEPTIC SHOCK	Infections and infestations	—	—	—
BLOOD POTASSIUM DECREASED	Investigations	—	—	—
PSEUDARTHROSIS	Musculoskeletal and connective tissue disorders	—	—	—
CEREBROVASCULAR ACCIDENT	Nervous system disorders	—	—	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—	—	—
OVERDOSE	Injury, poisoning and procedural complications	—	—	—
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	2 DAA+RBV	3DAA	3DAA+RBV
FATIGUE	General disorders	—	—	—
HEADACHE	Nervous system disorders	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—
RASH	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: ANAEMIA, GASTRIC PERFORATION, DEATH, HEPATIC CIRRHOSIS, OROPHARYNGEAL CANDIDIASIS, SEPTIC SHOCK, BLOOD POTASSIUM DECREASED, PSEUDARTHROSIS.

Data from ClinicalTrials.gov NCT02615145 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Chronic Hepatitis C

Currently open trials in the same condition.

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NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting

Other AbbVie trials

Trials by the same sponsor.

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NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02615145 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 7 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02615145.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing