NCT02798315 is a clinical trial in Chronic Hepatitis C, sponsored by AbbVie.

Who is sponsoring NCT02798315?

NCT02798315 is sponsored by AbbVie.

What condition does NCT02798315 study?

NCT02798315 studies Chronic Hepatitis C.

Is NCT02798315 still recruiting?

NCT02798315 is currently completed. Last updated 31 December 2018.

Are results published for NCT02798315?

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

Last reviewed 2018-12-31 · How we verify

NCT02798315

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

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

Completed Results posted Last updated 31 December 2018

What this trial tests

trial in Chronic Hepatitis C in 40 participants. Completed in 12 June 2017.

Timeline

25 May 2016

Primary endpoint
12 June 2017

12 June 2017

Quick facts

Lead sponsor	AbbVie
Status	Completed
Study type	OBSERVATIONAL
Enrollment	40
Start date	25 May 2016
Primary completion	12 June 2017
Estimated completion	12 June 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 (i.e. at least 70 days) after the last dose of study drug

SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	100	91.0 – 100.0

Percentage of Participants With Virological Response at End of Treatment (EoT) Secondary · Up to EoT, maximum of 24 weeks

Virological response defined as HCV RNA level less than 50 IU/mL.

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	100	91.0 – 100.0

Percentage of Participants With Relapse at EoT Secondary · Up to EoT, maximum of 24 weeks

Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	0

Percentage of Participants With Breakthrough. Secondary · Up to EoT, maximum of 24 weeks

Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment.

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	0

Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse Secondary · 12 weeks (i.e. at least 70 days) after the last dose of study drug

On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment).

On-treatment virologic failure

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	0

Relapse

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	0

Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria Secondary · 12 weeks (i.e. at least 70 days) after the last dose of study drug

Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria.

Premature study drug discontinuation

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	0

Missing SVR12 data / other

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	0

Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA Secondary · Up to 48 weeks

Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking \> 95% to ≤ 105% of the target dose and those taking \> 80% to ≤ 95% of the target dose.

> 95% to ≤ 105% of target dose

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	38

> 80% to ≤ 95% of target dose

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	1

Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV Secondary · Up to 48 weeks

Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking \> 95% to ≤ 105% of the target dose and those taking \> 80% to ≤ 95% of the target dose.

> 95% to ≤ 105% of target dose

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	32

> 80% to ≤ 95% of target dose

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	1

Adherence: Percentage of Planned Duration of RBV Taken by Participant Secondary · Up to 48 weeks

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	101.0	± 2.00

Change From Baseline in the PAM-13 Questionnaire Secondary · Up to 48 weeks

The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. 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). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	7.60	4.50 – 11.30

Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Secondary · Up to EoT, maximum of 24 weeks

Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders).

Personal support

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	28

Educational/information material - printed

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	24

Educational/information material - online

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	6

Additional resources - web portal

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	3

Additional resources - app

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	6

Additional resources - reminders

Group	Value	95% CI
Participants With HCV Genotype 1 or 4	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Nonserious adverse events (AEs): up to 48 Weeks. Serious AEs were reported to AbbVie from the time the physician obtains the participant's authorization to use and disclose information until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With HCV Genotype 1 or 4

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (3 terms — click to expand)

Reaction	System	Participants With HCV Geno…
Blood bilirubin increased	Investigations	—
Platelet count increased	Investigations	—
Overdose	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT02798315 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 Kuwait in a clinical practice patient population.

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.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
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 NCT02798315 (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: 31 December 2018

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/NCT02798315.

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