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Chronic Hepatitis CCITRINENCT02803138

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

An observational study of Chronic Hepatitis C, run by AbbVie at 18 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Ombitasvir/paritaprevir/ritonavir, Dasabuvir and Ribavirin
How many people
256 participants
Where
18 sitesIsrael
Study dates
7 Jul 2016to 21 Oct 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.

Who may be able to join

None listed.

Who cannot join

  • None

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Israel18 sites

  • Ha'Emek Medical Center /ID# 153695

    Afula, 18341

  • Assaf Harofeh Medical Center /ID# 153708

    Be’er Ya‘aqov, 70300

  • Soroka Medical Center /ID# 169357

    Beersheba, Southern District, 84101

  • Soroka Medical Ctr /ID# 153697

    Beersheba, 84101

  • Maccabi Health Services /ID# 158647

    GUSH DAN, 7565016

  • Hillel Yaffe Medical Center /ID# 153702

    Hadera, 38100

  • Rambam Health Care Campus /ID# 153694

    Haifa, 3109601

  • Bnai Zion Medical Center /ID# 153700

    Haifa, 3339419

  • The Lady Davis Carmel MC /ID# 153692

    Haifa, 3436212

  • The Edith Wolfson Medical Cent /ID# 153706

    Holon, 58100

  • Shaare Zedek Medical Center /ID# 153699

    Jerusalem, 91031

  • Hadassah /ID# 153701

    Jerusalem, 91120

  • Meir Medical Center /ID# 153698

    Kfar Saba, 44281

  • Western Galilee Medical Center /ID# 153705

    Nahariya, 22100

  • Rabin Medical Center /ID# 153696

    Petakh Tikva, Tel Aviv, 4941492

  • Rabin Medical Center /ID# 158648

    Petakh Tikva, Tel Aviv, 4941492

  • Sheba Medical Center /ID# 153707

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Ctr /ID# 153693

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C - An Observational Study in Israel (CITRINE STUDY)

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ 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 was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.

Read the detailed description

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. The prescription of a 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 participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).

Being tested
Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin, Patient support program
Keywords
Chronic Hepatitis C, Ombitasvir/paritaprevir/ritonavir ± dasabuvir, Sustained Virological Response, Observational Study, Chronic Hepatitis C genotype 1, Chronic Hepatitis C genotype 4
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ombitasvir/paritaprevir/ritonavirDrug

    Also called Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450

    Co-formulated tablet

  • DasabuvirDrug

    Also called ABT-333

    Tablet

  • RibavirinDrug

    Tablet

  • Patient support programBehavioural

    Supportive services provided to participants included reminder calls, emails, text messages, a Care Coach, and educational/informational materials.

Study groups in NCT02803138
Study groupRoleWhat they receive
Participants with HCV genotype 1 or 4Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
Receives: Drug: Ombitasvir/paritaprevir/ritonavir; Drug: Dasabuvir; Drug: Ribavirin; Behavioral: Patient support program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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

    Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (8)

  1. Percentage of Participants With Virologic Response at End of Treatment (EoT)

    Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.

    Measured: Up to 24 weeks

  2. Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment

    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 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria:

    • evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN
    • an HCV RNA value ≥50 IU/mL at the last measurement post-baseline
    • HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure

    Measured: 12 weeks (at least 70 days) after the last actual dose of study drug

  3. Percentage of Participants With Relapse

    Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.

    Measured: Up to 48 weeks after the last actual dose of study drug

  4. Percentage of Participants With Viral Breakthrough

    Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.

    Measured: Up to 24 weeks

  5. Percentage of Participants With On-treatment Virologic Failure

    On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (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).

    Measured: 12 weeks after the last actual dose of study drug

  6. Percentage of Participants Meeting Relapse Criteria

    Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.

    Measured: 12 weeks after the last actual dose of study drug

  7. Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

    Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.

    Measured: 12 weeks after the last actual dose of study drug

  8. Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

    The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.

    Measured: 12 weeks after the last actual dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study start7 Jul 2016
  3. Primary completion21 Oct 2018
  4. Study completion21 Oct 2018

Resources

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
Case only
Time perspective
Prospective
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02803138
Sponsor's protocol ID
P16-014
Acronym
CITRINE
Status last verified
Aug 2019
First submitted
14 Jun 2016
Last updated
11 Oct 2019
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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C, run by AbbVie at 18 sites in Israel.

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 0 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 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

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 11 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 Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of study drug). 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 NCT02803138, 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 11 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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