Hepatitis C Virus (HCV)Phase 3GEODE IINCT02609659

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin in people with Hepatitis C Virus (HCV), 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

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus (HCV)
What is being tested?: ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: No sites listed yet
Study dates: 28 Oct 2015to 28 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

Chronic hepatitis C virus (HCV) infection
Non-cirrhotic subjects
Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Who cannot join

Pregnant or breastfeeding women
Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
HCV genotype of any subtype other than GT1a or unable to subtype
Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

About this study

Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)

Conditions: Hepatitis C Virus (HCV)
Being tested: ombitasvir/paritaprevir/ritonavir and dasabuvir, ribavirin
Keywords: Chronic Hepatitis C Infection
Medical subject headings: 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
ribavirinDrug
Tablet

Study groups in NCT02609659
Study group	Role	What they receive
3-DAA + RBV 600 mg	Experimental	3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; 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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.
Measured: 12 weeks after the last actual dose of study drug
Percentage of Participants With Hemoglobin < 10 g/dL During Treatment
The percentage of participants with hemoglobin <10 g/dL during treatment is provided.
Measured: up to 12 weeks
Mean Change in Hemoglobin Values From Baseline to End of Treatment
The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.
Measured: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)

Secondary outcomes (2)

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 all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.
Measured: Up to 12 weeks
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, excluding reinfection, 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.

28 Oct 201528 Dec 2016

First posted20 Nov 2015 (estimated)
Study start28 Oct 2015
Primary completion7 Oct 2016
Study completion28 Dec 2016

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 Hepatitis C Virus (HCV)Studies 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: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02609659
Sponsor's protocol ID: M15-582
Acronym: GEODE II
Status last verified: Sep 2017
First submitted: 18 Nov 2015
Last updated: 10 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Poordad F, Sedghi S, Pockros PJ, Ravendhran N, Reindollar R, Lucey MR, Epstein M, Bank L, Bernstein D, Trinh R, Krishnan P, Polepally AR, Unnebrink K, Martinez M, Nelson DR. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. J Viral Hepat. 2019 Aug;26(8):1027-1030. doi: 10.1111/jvh.13109. Epub 2019 May 6.
PubMed 30980576

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

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All Hepatitis C Virus (HCV) trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
ClinicalTrials.gov ID: NCT02609659
Acronym / sponsor ID: GEODE II / M15-582
Conditions: Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 28 Oct 2015 (actual)
Primary completion: 7 Oct 2016 (actual)
Study completion: 28 Dec 2016 (actual)
First posted: 20 Nov 2015 (estimated)
Results: Posted 18 Oct 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
3-DAA + RBV 600 mg	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: ribavirin3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 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)

Chronic hepatitis C virus (HCV) infection
Non-cirrhotic subjects
Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Key exclusion criteria (5 listed)

Pregnant or breastfeeding women
Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
HCV genotype of any subtype other than GT1a or unable to subtype
Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

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	3-DAA + RBV 600 mg
ribavirinTablet	Drug	3-DAA + RBV 600 mg

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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.
Percentage of Participants With Hemoglobin < 10 g/dL During Treatment
Time frame: up to 12 weeks
The percentage of participants with hemoglobin <10 g/dL during treatment is provided.
Mean Change in Hemoglobin Values From Baseline to End of Treatment
Time frame: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)
The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.

2 secondary outcomes

Percentage of Participants With On-treatment Virologic Failure
Time frame: Up to 12 weeks
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 18 Oct 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
3-DAA + RBV 600 mg	105	97

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	3-DAA + RBV 600 mg n = 105
Value	89.5 (83.7 to 95.4)

3-DAA + RBV 600 mg: percentage of participants: 89.5 (95% CI 83.7 to 95.4)

Population analysed: Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after flanking imputation were counted as nonresponders.

Primary outcome: Percentage of Participants With Hemoglobin < 10 g/dL During Treatment

Time frame: up to 12 weeks. Number. Unit: percentage of participants

Measure	3-DAA + RBV 600 mg n = 104
Value	0

Population analysed: All participants who received at least 1 dose of study drug (ITT population) with at least one post-baseline hemoglobin value through the final treatment value.

Primary outcome: Mean Change in Hemoglobin Values From Baseline to End of Treatment

Time frame: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks). Mean (Standard Deviation). Unit: g/L

Measure	3-DAA + RBV 600 mg n = 104
Week 2	-6.4 (8.17)
Week 4	-8.9 (9.37)
Week 8	-11.2 (9.85)
Week 12	-12.4 (10.06)
Final Treatment Visit	-12.1 (9.90)

Population analysed: All participants who received at least 1 dose of study drug (ITT population) with a hemoglobin value at baseline and at given timepoint.

2 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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3-DAA + RBV 600 mg	3 of 105 (2.9%)	53 of 105 (50.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30980576Poordad F, Sedghi S, Pockros PJ, Ravendhran N, Reindollar R, Lucey MR, Epstein M, Bank L, Bernstein D, Trinh R, Krishnan P, Polepally AR, Unnebrink K, Martinez M, Nelson DR. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. J Viral Hepat. 2019 Aug;26(8):1027-1030. doi: 10.1111/jvh.13109. Epub 2019 May 6.
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 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin in people with Hepatitis C Virus (HCV), 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 10 Dec 2019. 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 18 Oct 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). The study lists 3 primary outcomes in all. 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 NCT02609659, 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 10 Dec 2019.