Hepatitis C, ChronicNCT02118597

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 7 sites in Hungary.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Boceprevir, Simeprevir and Pegylated Interferon (Peginterferon) Alfa-2a
How many people: 19 participants
Where: 7 sitesHungary
Study dates: May 2014to May 2015
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 genotype 1 chronic hepatitis C (CHC) infection taking triple combination therapy (boceprevir, peginterferon alfa-2a and ribavirin)

Who may be able to join

18 years of age or over
Genotype 1 CHC infection
Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)

Who cannot join

Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop < 1 log10) or at week 12 (HCV RNA >/= 15 international units/milliliter [IU/mL]) and switching to triple combination therapy with boceprevir

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Hungary7 sites

Study site
Békéscsaba, 5600
Study site
Budapest, 1097
Study site
Budapest, 1125
Study site
Debrecen, 4032
Study site
Eger, 3300
Study site
Kaposvár, 7400
Study site
Szombathely, 8800

Other trials in Hungary

About this study

Official title: Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL)

This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

Conditions: Hepatitis C, Chronic
Being tested: Boceprevir, Simeprevir, Pegylated Interferon (Peginterferon) Alfa-2a, Ribavirin
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.

BoceprevirDrug
Also called Victrelis
Boceprevir administered according to corresponding summary of product characteristics (SmPC).
SimeprevirDrug
Also called Olysio
Simeprevir administered according to corresponding summary of product characteristics (SmPC).
Pegylated Interferon (Peginterferon) Alfa-2aDrug
Also called Pegasys
Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).
RibavirinDrug
Also called Copegus
Ribavirin according to corresponding summary of product characteristics (SmPC).

Study groups in NCT02118597
Study group	Role	What they receive
Triple Combination Therapy		Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed. Receives: Drug: Boceprevir; Drug: Simeprevir; Drug: Pegylated Interferon (Peginterferon) Alfa-2a; Drug: Ribavirin

What is being measured

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

Sustained Virological Response 24 (SVR24) Rate
The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.
Measured: 24 weeks after end of treatment (EOT) at Week 72

Secondary outcomes (10)

Percentage of Participants With Virological Response
Virological response is defined as HCV RNA <15 IU/mL.
Measured: Weeks 4, 8, 12, and 24
Number of Participants With Virological Breakthrough
Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.
Measured: Up to Week 48
Number of Participants With Virological Relapse
Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.
Measured: Week 49 up to Week 72
Number of Participants With Treatment Discontinuation Due to Futility
Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.
Measured: Up to Week 48
Number of Participants With Treatment Discontinuation
Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.
Measured: Up to Week 48
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Up to 72 weeks
Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate
Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.
Measured: Screening (before Week 1)
Percentage of Participants With Positive Predictive Value of Liver Fibrosis
The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.
Measured: Screening (before Week 1)
Predictive Value of HCV Disease Characteristics
HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.
Measured: Screening (before Week 1)
Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)
Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.
Measured: Up to 72 weeks

Timeline

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

May 2014May 2015

First posted21 Apr 2014 (estimated)
Study startMay 2014
Primary completionMay 2015
Study completionMay 2015

Why it stopped: Study terminated due to the Sponsor's decision.

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 Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02118597
Sponsor's protocol ID: ML29278
Status last verified: Oct 2016
First submitted: 16 Apr 2014
Last updated: 12 Dec 2016
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

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 Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL)
ClinicalTrials.gov ID: NCT02118597
Acronym / sponsor ID: ML29278
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: TerminatedReason stopped: Study terminated due to the Sponsor's decision.
Enrolment: 19 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 12 Dec 2016

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Triple Combination Therapy	–	Drug: Boceprevir, Drug: Simeprevir, Drug: Pegylated Interferon (Peginterferon) Alfa-2a, Drug: RibavirinParticipants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with genotype 1 chronic hepatitis C (CHC) infection taking triple combination therapy (boceprevir, peginterferon alfa-2a and ribavirin)

Key inclusion criteria (5 listed)

18 years of age or over
Genotype 1 CHC infection
Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)

Key exclusion criteria (1 listed)

Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop < 1 log10) or at week 12 (HCV RNA >/= 15 international units/milliliter [IU/mL]) and switching to triple combination therapy with boceprevir

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
BoceprevirAlso: VictrelisBoceprevir administered according to corresponding summary of product characteristics (SmPC).	Drug	Triple Combination Therapy
SimeprevirAlso: OlysioSimeprevir administered according to corresponding summary of product characteristics (SmPC).	Drug	Triple Combination Therapy
Pegylated Interferon (Peginterferon) Alfa-2aAlso: PegasysPegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).	Drug	Triple Combination Therapy
RibavirinAlso: CopegusRibavirin according to corresponding summary of product characteristics (SmPC).	Drug	Triple Combination Therapy

Primary outcome

Sustained Virological Response 24 (SVR24) Rate
Time frame: 24 weeks after end of treatment (EOT) at Week 72
The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.

10 secondary outcomes

Percentage of Participants With Virological Response
Time frame: Weeks 4, 8, 12, and 24
Number of Participants With Virological Breakthrough
Time frame: Up to Week 48
Number of Participants With Virological Relapse
Time frame: Week 49 up to Week 72
Number of Participants With Treatment Discontinuation Due to Futility
Time frame: Up to Week 48
Number of Participants With Treatment Discontinuation
Time frame: Up to Week 48
Number of Participants With Adverse Events
Time frame: Up to 72 weeks
Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate
Time frame: Screening (before Week 1)
Percentage of Participants With Positive Predictive Value of Liver Fibrosis
Time frame: Screening (before Week 1)
Predictive Value of HCV Disease Characteristics
Time frame: Screening (before Week 1)
Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)
Time frame: Up to 72 weeks

Results and safety

Results posted to the registry on 12 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triple Combination Therapy	19	3

Primary outcome: Sustained Virological Response 24 (SVR24) Rate

Time frame: 24 weeks after end of treatment (EOT) at Week 72. Number. Unit: percentage of participants

Measure	Triple Combination Therapy n = 1
Value	0

Population analysed: Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent form up to the end of study (up to 72 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triple Combination Therapy	5 of 19 (26.3%)	14 of 19 (73.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C, Chronic

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.

Clinical Trials study director

Hoffmann-La Roche

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 7 sites in Hungary.

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 5 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: stopped early, as of the sponsor's last update on 12 Dec 2016. 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 Hungary. 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 12 Dec 2016). 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?

Sustained Virological Response 24 (SVR24) Rate (time frame: 24 weeks after end of treatment (EOT) at Week 72). 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 NCT02118597.

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 2016.