Hepatitis C, ChronicNCT01392742

An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 9 sites in Bulgaria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
How many people: 443 participants
Where: 9 sitesBulgaria
Study dates: 31 May 2011to 31 Jul 2014
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: Patients with chronic hepatitis C treated with Pegasys and ribavirin

Who may be able to join

Adult patients, >/= 18 years of age
Serologically confirmed chronic hepatitis C (all genotypes)
Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Who cannot join

Coinfection with HIV and/or hepatitis B
Contraindications according to the SPC for Pegasys/ribavirin

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Bulgaria9 sites

Mhat - Pleven; Clinic of Gastroenterology
Pleven, 5800
Umhat St. Georgi; Clinical of Gastroenterology
Plovdiv, 4002
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, 1407
UMHAT Alexandrovska EAD; Gastroenterology
Sofia, 1431
Mhat Queenjoanna; Clinic of Gastroenterology
Sofia, 1527
Military Medical Academy; Gastroenterology
Sofia, 1606
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, 1612
Mhat St. Zagora; Clinical of Gastroenterology
Stara Zagora, 6000
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, 9010

Other trials in Bulgaria

About this study

Official title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin

Conditions: Hepatitis C, Chronic
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.

Study groups in NCT01392742
Study group	Role	What they receive
Cohort		Not described

What is being measured

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

Percentage of Participants With Sustained Virological Response (SVR)
SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).
Measured: 24 weeks after End of treatment (EOT) (up to Week 96)
Percentage of Participants With Relapse
Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.
Measured: Up to 24 weeks after EOT (up to Week 96)
Percentage of Participants Who Were Non-Responders
Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.
Measured: Up to 24 weeks after EOT (up to Week 96)

Secondary outcomes (9)

Percentage of Participants With Positive Predictive Value on SVR at Week 4
Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.
Measured: Week 4
Percentage of Participants With Positive Predictive Value on SVR at Week 12
Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.
Measured: Week 12
Correlation of SVR With Rapid Virological Response (RVR)
Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.
Measured: Up to 24 weeks after EOT (up to Week 96)
Correlation of SVR With Early Virological Response (EVR)
Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.
Measured: Up to 24 weeks after EOT (up to Week 96)
Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response
Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.
Measured: Week 4 and 12
Duration of Treatment in Participants With SVR by HCV Genotype
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Measured: Up to Week 72
Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Measured: Up to Week 72
Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Measured: Up to Week 72
Percentage of Participants With Virological Response
The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.
Measured: 4 weeks after EOT (up to Week 76)

Timeline

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

31 May 201131 Jul 2014

First posted12 Jul 2011 (estimated)
Study start31 May 2011
Primary completion31 Jul 2014
Study completion31 Jul 2014

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: Cohort
Time perspective: Prospective
Enrolment: 443 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01392742
Sponsor's protocol ID: ML25670
Status last verified: Mar 2017
First submitted: 11 Jul 2011
Last updated: 10 Apr 2017
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
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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 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin
ClinicalTrials.gov ID: NCT01392742
Acronym / sponsor ID: ML25670
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 443 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 May 2011 (actual)
Primary completion: 31 Jul 2014 (actual)
Study completion: 31 Jul 2014 (actual)
First posted: 12 Jul 2011 (estimated)
Results: Posted 14 Dec 2015

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: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic hepatitis C treated with Pegasys and ribavirin

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Serologically confirmed chronic hepatitis C (all genotypes)
Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Key exclusion criteria (2 listed)

Coinfection with HIV and/or hepatitis B
Contraindications according to the SPC for Pegasys/ribavirin

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

Primary outcome

Percentage of Participants With Sustained Virological Response (SVR)
Time frame: 24 weeks after End of treatment (EOT) (up to Week 96)
SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).
Percentage of Participants With Relapse
Time frame: Up to 24 weeks after EOT (up to Week 96)
Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.
Percentage of Participants Who Were Non-Responders
Time frame: Up to 24 weeks after EOT (up to Week 96)
Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.

9 secondary outcomes

Percentage of Participants With Positive Predictive Value on SVR at Week 4
Time frame: Week 4
Percentage of Participants With Positive Predictive Value on SVR at Week 12
Time frame: Week 12
Correlation of SVR With Rapid Virological Response (RVR)
Time frame: Up to 24 weeks after EOT (up to Week 96)
Correlation of SVR With Early Virological Response (EVR)
Time frame: Up to 24 weeks after EOT (up to Week 96)
Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response
Time frame: Week 4 and 12
Duration of Treatment in Participants With SVR by HCV Genotype
Time frame: Up to Week 72
Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype
Time frame: Up to Week 72
Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype
Time frame: Up to Week 72
Percentage of Participants With Virological Response
Time frame: 4 weeks after EOT (up to Week 76)

Results and safety

Results posted to the registry on 14 Dec 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
Hepatitis C Virus (HCV) Infected Participants	443	242

Primary outcome: Percentage of Participants With Sustained Virological Response (SVR)

Time frame: 24 weeks after End of treatment (EOT) (up to Week 96). Number. Unit: percentage of participants

Measure	HCV Infected Participants n = 331
Value	38.7

Population analysed: Per Protocol (PP) population included all participants without any protocol violation.

Primary outcome: Percentage of Participants With Relapse

Time frame: Up to 24 weeks after EOT (up to Week 96). Number. Unit: percentage of participants

Measure	HCV Infected Participants n = 331
Value	8.2

Population analysed: PP population.

Primary outcome: Percentage of Participants Who Were Non-Responders

Time frame: Up to 24 weeks after EOT (up to Week 96). Number. Unit: percentage of participants

Measure	HCV Infected Participants n = 331
Value	25.1

Population analysed: PP population.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks after EOT (up to Week 96). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HCV Infected Participants	17 of 440 (3.9%)	273 of 440 (62%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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

9 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 9 sites in Bulgaria.

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 3 inclusion and 2 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Bulgaria. 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 14 Dec 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?

Percentage of Participants With Sustained Virological Response (SVR) (time frame: 24 weeks after End of treatment (EOT) (up to Week 96)). 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 NCT01392742.

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 Apr 2017.