Chronic Hepatitis C InfectionPhase 2CORAL-INCT01782495

A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients

A Phase 2 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir and ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie.

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 purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C Infection
What is being tested?: ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir and ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: No sites listed yet
Study dates: 25 Feb 2013to 13 Jul 2017
Phase: Phase 2
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

Who may be able to join

Male or female, at least 18 years of age at the time of screening.
Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg/day.
Hepatitis C virus (HCV) interferon (IFN) therapy treatment-naïve or -experienced, either pre- or post-liver or renal transplant.
Screening HCV genotype testing indicating infection with genotype 1 or 4 (GT1 or GT4) only.

Who cannot join

Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
Use of any medications contraindicated for use with the study regimen as well as those that are contraindicated for use with either ritonavir or ribavirin within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer.
Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Documented history of post-transplant complications directly involving the hepatic or renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the portal vein, the hepatic artery and/or hepatic vein.
Clinically significant abnormalities, other than HCV infection, in a subject post-transplant based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.

About this study

Official title: Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With Hepatitis C Virus (HCV) Infection (CORAL-I)

Conditions: Chronic Hepatitis C Infection
Being tested: ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
Keywords: Hepatitis C Genotype 4, Chronic Hepatitis, Interferon-Free, Hepatitis C Virus (HCV), Renal Transplant, Liver Transplant, Hepatitis C Genotype 1
Medical subject headings: Hepatitis, Chronic, Hepatitis C

What participants receive

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

ombitasvir/paritaprevir/ritonavir and dasabuvirDrug
Also called Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
ombitasvir/paritaprevir/ritonavirDrug
Also called TECHNIVIE, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267
Tablet; ombitasvir coformulated with paritaprevir and ritonavir
ribavirinDrug
tablet

Study groups in NCT01782495
Study group	Role	What they receive
Arm A	Experimental	Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin
Arm B	Experimental	Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin
Arm C	Experimental	Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Arm D	Experimental	Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin
Arm E	Experimental	Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin
Arm F	Experimental	Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin
Arm G	Experimental	Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Arm H	Experimental	Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin
Arm I	Experimental	Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Arm J	Experimental	Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir; Drug: ribavirin
Arm K	Experimental	Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir; Drug: ribavirin

What is being measured

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

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (3)

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 24 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Measured: 24 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment.
Measured: Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: From the end of treatment through 12 weeks after the last 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.

25 Feb 201313 Jul 2017

First posted4 Feb 2013 (estimated)
Study start25 Feb 2013
Primary completion2 Nov 2016
Study completion13 Jul 2017

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 C InfectionStudies 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01782495
Sponsor's protocol ID: M12-999
Other IDs: 2012-004792-39
Acronym: CORAL-I
Status last verified: Oct 2017
First submitted: 22 Jan 2013
Last updated: 7 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, Gordon F, Levitsky J, Terrault NA, Burton JR Jr, Xie W, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Forns X. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014 Dec 18;371(25):2375-82. doi: 10.1056/NEJMoa1408921. Epub 2014 Nov 11.
PubMed 25386767

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With Hepatitis C Virus (HCV) Infection (CORAL-I)
ClinicalTrials.gov ID: NCT01782495
Acronym / sponsor ID: CORAL-I / M12-999
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Genotype 4, Chronic Hepatitis, Interferon-Free, Hepatitis C Virus (HCV), Renal Transplant, Liver Transplant, Hepatitis C Genotype 1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 25 Feb 2013 (actual)
Primary completion: 2 Nov 2016 (actual)
Study completion: 13 Jul 2017 (actual)
First posted: 4 Feb 2013 (estimated)
Results: Posted 7 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
Arm A	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirinLiver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Arm B	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirinLiver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Arm C	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvirLiver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
Arm D	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirinLiver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Arm E	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirinLiver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Arm F	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirinLiver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Arm G	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvirLiver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Arm H	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirinRenal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Arm I	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvirRenal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Arm J	Experimental	Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirinLiver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Arm K	Experimental	Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirinLiver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, at least 18 years of age at the time of screening.
Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg/day.
Hepatitis C virus (HCV) interferon (IFN) therapy treatment-naïve or -experienced, either pre- or post-liver or renal transplant.
Screening HCV genotype testing indicating infection with genotype 1 or 4 (GT1 or GT4) only.

Key exclusion criteria (5 listed)

Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
Use of any medications contraindicated for use with the study regimen as well as those that are contraindicated for use with either ritonavir or ribavirin within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer.
Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Documented history of post-transplant complications directly involving the hepatic or renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the portal vein, the hepatic artery and/or hepatic vein.
Clinically significant abnormalities, other than HCV infection, in a subject post-transplant based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ombitasvir/paritaprevir/ritonavir and dasabuvirAlso: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet	Drug	Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm G, Arm H, Arm I
ombitasvir/paritaprevir/ritonavirAlso: TECHNIVIE, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267Tablet; ombitasvir coformulated with paritaprevir and ritonavir	Drug	Arm J, Arm K
ribavirintablet	Drug	Arm A, Arm B, Arm D, Arm E, Arm F, Arm H, Arm J, Arm K

Primary outcome

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.

3 secondary outcomes

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Time frame: 24 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
Time frame: Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)
Percentage of Participants With Post-treatment Relapse
Time frame: From the end of treatment through 12 weeks after the last dose of study drug

Results and safety

Results posted to the registry on 7 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	34	34
Arm B	27	26
Arm C	13	13
Arm D	4	4
Arm E	2	2
Arm F	22	22
Arm G	12	12
Arm H	9	6
Arm I	3	3
Arm J	2	2
Arm K	1	1

Primary outcome: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Time frame: 12 weeks after the last actual dose of study drug. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Arm A n = 34	Arm B n = 27	Arm C n = 13	Arm D n = 4	Arm E n = 2	Arm F n = 22	Arm G n = 12	Arm H n = 9	Arm I n = 3	Arm J n = 2	Arm K n = 1
Value	97.1 (85.1 to 99.5)	96.3 (81.7 to 99.3)	100 (77.2 to 100.0)	100 (51.0 to 100.0)	100 (34.2 to 100.0)	95.5 (78.2 to 99.2)	100 (75.8 to 100.0)	66.7 (35.4 to 87.9)	100 (43.9 to 100.0)	100 (34.2 to 100.0)	100 (20.7 to 100.0)

Population analysed: Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARM A	2 of 34 (5.9%)	33 of 34 (97.1%)	0 of 34
ARM B	1 of 27 (3.7%)	27 of 27 (100%)	0 of 27
ARM C	0 of 13 (0%)	12 of 13 (92.3%)	0 of 13
ARM D	0 of 4 (0%)	4 of 4 (100%)	0 of 4
ARM E	0 of 2 (0%)	2 of 2 (100%)	0 of 2
ARM F	2 of 22 (9.1%)	22 of 22 (100%)	0 of 22
ARM G	1 of 12 (8.3%)	12 of 12 (100%)	0 of 12
ARM H	4 of 9 (44.4%)	8 of 9 (88.9%)	1 of 9
ARM I	0 of 3 (0%)	3 of 3 (100%)	0 of 3
ARM J	0 of 2 (0%)	2 of 2 (100%)	0 of 2
ARM K	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25386767Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, Gordon F, Levitsky J, Terrault NA, Burton JR Jr, Xie W, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Forns X. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014 Dec 18;371(25):2375-82. doi: 10.1056/NEJMoa1408921. Epub 2014 Nov 11.
Related InfoLink provided by the sponsor.

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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?

A Phase 2 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir and ribavirin in people with Chronic Hepatitis C Infection, 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 5 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 Nov 2017. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2017). 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 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 NCT01782495, 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 Nov 2017.