NCT02807402 is a clinical trial in Chronic Hepatitis C, sponsored by AbbVie.

Who is sponsoring NCT02807402?

NCT02807402 is sponsored by AbbVie.

What condition does NCT02807402 study?

NCT02807402 studies Chronic Hepatitis C.

Is NCT02807402 still recruiting?

NCT02807402 is currently completed. Last updated 25 January 2019.

Are results published for NCT02807402?

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

Last reviewed 2019-01-25 · How we verify

NCT02807402

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

Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania

Completed Results posted Last updated 25 January 2019

What this trial tests

trial in Chronic Hepatitis C in 522 participants. Completed in 4 August 2017.

Timeline

14 July 2016

Primary endpoint
4 August 2017

4 August 2017

Quick facts

Lead sponsor	AbbVie
Status	Completed
Study type	OBSERVATIONAL
Enrollment	522
Start date	14 July 2016
Primary completion	4 August 2017
Estimated completion	4 August 2017

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 Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) Primary · 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.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	98.1	96.5 – 99.0

Percentage of Participants Achieving Virological Response at End of Treatment Secondary · End of treatment (week 12 or 24 depending on the treatment regimen)

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	99.6	98.6 – 99.9

Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment Secondary · 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. The core population with sufficient follow-up data regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir and dasabuvir * 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 ≥ 70 days after the last actual dose of par

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	98.5	97.0 – 99.2

Percentage of Participants With Relapse Secondary · End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

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.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.8	0.3 – 2.0

Percentage of Participants With Breakthrough Secondary · 12 or 24 weeks (depending on the treatment regimen)

Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.00	0.0 – 9.6

Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment Secondary · 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

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 virological failure; * Missing SVR12 data and/or none of the above criteria.

On-treatment virologic failure

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.2

Relapse

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.8

Death

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.6

Premature treatment discontinuation

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.2

None of the above criteria

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	0.2

Assigned Treatment Regimen Secondary · Baseline

Treatment regimen was assigned by the physician according to local practice and label. Participants could receive three direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	73
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	438
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	8

Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA Secondary · From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.

Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	6
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	483
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	28
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	1

Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin Secondary · From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	6
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	349
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	39
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	22

Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days Secondary · From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin	94.5	± 19.12

Number of Participants With Comorbidities Secondary · Baseline

Any comorbidity or coinfection

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin	335

Any coinfection

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin	9

Coinfection with human immunodeficiency virus (HIV

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin	4

Coinfection with hepatitis B virus

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin	6

Number of Participants Who Received Concomitant Medications Secondary · From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

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.

Group	Value	95% CI
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin	263

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Paritaprevir/Ritonavir + Ombitasvir With RBV

Serious: 0/3 (0%)

Deaths: 0/3

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV

Serious: 3/73 (4%)

Deaths: 0/73

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV

Serious: 17/446 (4%)

Deaths: 3/446

Serious adverse events (17 terms)

Reaction	System	Paritaprevir/Ritonavir + O…	Paritaprevir/Ritonavir + O…	Paritaprevir/Ritonavir + O…
ANAEMIA	Blood and lymphatic system disorders	—	—	—
JAUNDICE	Hepatobiliary disorders	—	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—	—
ENTEROCOLITIS	Gastrointestinal disorders	—	—	—
GASTRIC VARICES HAEMORRHAGE	Gastrointestinal disorders	—	—	—
GASTRITIS	Gastrointestinal disorders	—	—	—
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—
CHOLANGITIS	Hepatobiliary disorders	—	—	—
HEPATIC FAILURE	Hepatobiliary disorders	—	—	—
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	—	—	—
PYELONEPHRITIS ACUTE	Infections and infestations	—	—	—
PYONEPHROSIS	Infections and infestations	—	—	—
HYPERKALAEMIA	Metabolism and nutrition disorders	—	—	—
HYPONATRAEMIA	Metabolism and nutrition disorders	—	—	—
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
HAEMATURIA	Renal and urinary disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Paritaprevir/Ritonavir + O…	Paritaprevir/Ritonavir + O…	Paritaprevir/Ritonavir + O…
ANAEMIA	Blood and lymphatic system disorders	—	—	—

Most-reported serious reactions: ANAEMIA, JAUNDICE, ATRIAL FIBRILLATION, ENTEROCOLITIS, GASTRIC VARICES HAEMORRHAGE, GASTRITIS, GASTROINTESTINAL HAEMORRHAGE, NAUSEA.

Data from ClinicalTrials.gov NCT02807402 adverse events section.

Sponsor's own description

This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Ferenci P, Bourgeois S, Buggisch P, Norris S, et al · · 2019 · cited 6× · PMID 30739368 · DOI 10.1111/jvh.13080

Verify or expand the search:

Other recruiting trials for Chronic Hepatitis C

Currently open trials in the same condition.

NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
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 NCT02807402 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 25 January 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/NCT02807402.

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