HCV InfectionPhase 2NCT00726882

A Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies

A Phase 2 study testing Blood sample collection only and ABT-333 in people with HCV Infection, run by AbbVie (prior sponsor, Abbott) at 7 sites in 2 countries.

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 follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HCV Infection
What is being tested?: Blood sample collection only and ABT-333
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 7 sitesin 2 countries
Study dates: Aug 2008to May 2010
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Main Selection Criteria: Subject received ABT-333 or matching placebo in a prior clinical study involving ABT-333.

Who cannot join

The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in prior ABT-333 clinical study.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

Site Reference ID/Investigator# 17665
Anaheim, California, 92801
Site Reference ID/Investigator# 17667
Baton Rouge, Louisiana, 70808
Site Reference ID/Investigator# 17367
Los Angeles, California, 90036
Site Reference ID/Investigator# 17672
Los Angeles, California, 90048
Site Reference ID/Investigator# 10381
Orlando, Florida, 32803
Site Reference ID/Investigator# 14461
San Antonio, Texas, 78215

Other trials in United States

Puerto Rico1 site

Site Reference ID/Investigator# 11141
Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-333 After Discontinuation of ABT-333 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-333 Clinical Studies

The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).

Read the detailed description

This Phase 2, multicenter study was conducted in HCV-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in Study M10-351 Substudy 2 (NCT00696904; ABT-333 dosing duration was 2 days) and Study M10-380 (NCT00851890; ABT-333 dosing duration was 28 days) were eligible.

After receiving at least 1 dose of ABT-333 or placebo, subjects were assessed for participation in this rollover study and asked to review the informed consent. The day of study completion or early discontinuation from the prior ABT-333 clinical study served as the baseline assessment. If it was found that a participant received placebo during the previous ABT-333 clinical study, the sites were instructed to discontinue the participant from this study.

This study included approximately monthly blood sample collection procedures for 48 weeks, and no treatment was provided during this time.

Conditions: HCV Infection
Being tested: Blood sample collection only, ABT-333
Keywords: HCV 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.

Blood sample collection onlyProcedure or surgery
Approximately monthly collection of blood samples.
ABT-333Drug
Also called dasabuvir
Previous treatment in prior ABT-333 studies.

Study groups in NCT00726882
Study group	Role	What they receive
HCV-infected Participants	Other	Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Participants received no treatment in this follow-up study. Receives: Procedure: Blood sample collection only; Drug: ABT-333

What is being measured

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

Persistence of Resistance-Associated Variants and Phenotypic Resistance
Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.
Measured: Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks

Secondary outcomes (1)

Number of Participants With Serious Adverse Events Related to Study Procedures
Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.
Measured: 48 weeks

Timeline

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

Aug 2008May 2010

First posted1 Aug 2008 (estimated)
Study startAug 2008
Primary completionMay 2010
Study completionMay 2010

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 HCV InfectionStudies of the same condition, open and under way.
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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00726882
Sponsor's protocol ID: M10-459
Status last verified: Dec 2014
First submitted: 30 Jul 2008
Last updated: 8 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All HCV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-333 After Discontinuation of ABT-333 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-333 Clinical Studies
ClinicalTrials.gov ID: NCT00726882
Acronym / sponsor ID: M10-459
Conditions: HCV Infection
Keywords: HCV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 1 Aug 2008 (estimated)
Results: Posted 8 Jan 2015

Clinical summary

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

The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).

Detailed description

This study included approximately monthly blood sample collection procedures for 48 weeks, and no treatment was provided during this time.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HCV-infected Participants	Other	Procedure: Blood sample collection only, Drug: ABT-333Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Participants received no treatment in this follow-up study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Main Selection Criteria: Subject received ABT-333 or matching placebo in a prior clinical study involving ABT-333.

Key exclusion criteria (1 listed)

The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in prior ABT-333 clinical study.

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
Blood sample collection onlyApproximately monthly collection of blood samples.	Procedure or surgery	HCV-infected Participants
ABT-333Also: dasabuvirPrevious treatment in prior ABT-333 studies.	Drug	HCV-infected Participants

Primary outcome

Persistence of Resistance-Associated Variants and Phenotypic Resistance
Time frame: Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks
Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.

1 secondary outcome

Number of Participants With Serious Adverse Events Related to Study Procedures
Time frame: 48 weeks

Results and safety

Results posted to the registry on 8 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HCV-infected Participants	35	13

Primary outcome: Persistence of Resistance-Associated Variants and Phenotypic Resistance

Time frame: Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks. Number. Unit: participants

Measure	Participants From Study M10-380 n = 5	Participants From Study M10-351 n = 4
Post-Treatment Variants in NS5B (m=5; n=3)	4	0
Post-Treatment Resistance > 10-fold (m=5; n=4)	2	0

Population analysed: Resistance analyses included all participants who received ABT-333 in the previous study who had sufficient HCV RNA recovered from samples collected during this study for genotypic and phenotypic analysis to proceed. m, n = the number of evaluable participants for the analysis specified for M10-380 and M10-351, respectively.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HCV-infected Participants	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Daniel E Cohen, MD study director

AbbVie

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blood sample collection only and ABT-333 in people with HCV Infection, run by AbbVie (prior sponsor, Abbott) at 7 sites in 2 countries.

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 1 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Puerto Rico. 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.

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 8 Jan 2015). 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?

Persistence of Resistance-Associated Variants and Phenotypic Resistance (time frame: Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks). 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 NCT00726882.

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 8 Jan 2015.