Chronic Hepatitis C InfectionPhase 3GEODE - INCT02504099

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir and ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage… 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: 3 participants
Where: No sites listed yet
Study dates: Jul 2015to Dec 2016
Phase: Phase 3
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 time of screening
Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection
Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening
A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that requires the need to apply diuretic treatment to control ascites
Documented complete response to HCC treatment.
Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control.

Who cannot join

Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up.
Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.

About this study

Official title: Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)

Conditions: Chronic Hepatitis C Infection
Being tested: ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
Keywords: Chronic Hepatitis C Infection, Early Stage Hepatocellular Carcinoma

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 NCT02504099
Study group	Role	What they receive
OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks	Experimental	OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; 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 flanking imputation were imputed as nonresponders.
Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (4)

Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ throughout treatment with at least 6 weeks of treatment.
Measured: Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-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
Percentage of Participants With Long Term Clinical Outcomes
The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.
Measured: up to 48 weeks
Percentage of Participants With Recurrent HCV Infection Post Liver Transplant
The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.
Measured: from liver transplant to 24 weeks post-treatment (up to 48 weeks)

Timeline

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

Jul 2015Dec 2016

First posted21 Jul 2015 (estimated)
Study startJul 2015
Primary completionSep 2016
Study completionDec 2016

Why it stopped: Study stopped due to low enrollment

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.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02504099
Sponsor's protocol ID: M14-726
Other IDs: 2015-001049-10, 2015
Acronym: GEODE - I
Status last verified: Nov 2017
First submitted: 20 Jul 2015
Last updated: 12 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)
ClinicalTrials.gov ID: NCT02504099
Acronym / sponsor ID: GEODE - I / M14-726
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Infection, Early Stage Hepatocellular Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped due to low enrollment
Enrolment: 3 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Sep 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 21 Jul 2015 (estimated)
Results: Posted 12 Dec 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirinOBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

Who may qualify

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

Key inclusion criteria (7 listed)

Male or female, at least 18 years of age at time of screening
Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection
Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening
Documented complete response to HCC treatment.

Key exclusion criteria (4 listed)

Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up.
Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant 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	OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
ombitasvir/paritaprevir/ritonavirAlso: Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267Tablet; ombitasvir coformulated with paritaprevir and ritonavir	Drug	OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
ribavirinTablet	Drug	OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks

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 flanking imputation were imputed as nonresponders.

4 secondary outcomes

Percentage of Participants With On-treatment Virologic Failure
Time frame: Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-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
Percentage of Participants With Long Term Clinical Outcomes
Time frame: up to 48 weeks
Percentage of Participants With Recurrent HCV Infection Post Liver Transplant
Time frame: from liver transplant to 24 weeks post-treatment (up to 48 weeks)

Results and safety

Results posted to the registry on 12 Dec 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
OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks	3	3

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

Population analysed: The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.

4 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 16 weeks for participants treated for 12 weeks and up to 28 weeks for participants treated for 24 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks	0 of 3 (0%)	3 of 3 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Chronic Hepatitis C Infection

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

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 3 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Dec 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 NCT02504099.

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 12 Dec 2017.