Hepatitis C, ChronicNCT02556307

A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 4 sites in Slovenia.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Peginterferon alfa-2a and Ribavirin
How many people: 270 participants
Where: 4 sitesSlovenia
Study dates: Mar 2009to 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: Slovenian patients with chronic hepatitis C (CHC) treated with Peginterferon alfa-2a and ribavirin.

Who may be able to join

Male and female patients >/= 18 years
Positive test for HCV
Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Who cannot join

Concomitant infection with HIV or hepatitis B
Participation in a clinical trial within 30 days prior to study start
Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Trial locations and contacts

4 sites in 1 country.

Slovenia4 sites

Study site
Celje, 3000
Study site
Ljubljana, 1000
Study site
Maribor, 2000
Study site
Novo Mesto, 8000

Other trials in Slovenia

About this study

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

Conditions: Hepatitis C, Chronic
Being tested: 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.

Peginterferon alfa-2aDrug
Also called Pegasys
Peginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.
RibavirinDrug
Also called Copegus
Ribavirin according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.

Study groups in NCT02556307
Study group	Role	What they receive
Peginterferon alfa-2a + Ribavirin		Not described Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

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

Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).
Measured: 6 months after the last study drug administration (up to 123.6 weeks)

Secondary outcomes (6)

Percentage of Participants With Undetectable HCV RNA
Undetectable HCV RNA=a single last HCV RNA <20 IU/mL
Measured: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)
HCV RNA Values
Measured: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Thrombocyte Values
Measured: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Leukocyte Values
Measured: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hemoglobin Values
Measured: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
Measured: Up to 99.6 Weeks

Timeline

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

Mar 2009Jul 2014

First posted22 Sep 2015 (estimated)
Study startMar 2009
Primary completionJul 2014
Study completionJul 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: Case only
Time perspective: Prospective
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02556307
Sponsor's protocol ID: ML22263
Status last verified: Jan 2016
First submitted: 21 Sep 2015
Last updated: 15 Feb 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 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients
ClinicalTrials.gov ID: NCT02556307
Acronym / sponsor ID: ML22263
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Sep 2015 (estimated)
Results: Posted 15 Feb 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
Peginterferon alfa-2a + Ribavirin	–	Drug: Peginterferon alfa-2a, Drug: Ribavirin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Slovenian patients with chronic hepatitis C (CHC) treated with Peginterferon alfa-2a and ribavirin.

Key inclusion criteria (3 listed)

Male and female patients >/= 18 years
Positive test for HCV
Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Key exclusion criteria (3 listed)

Concomitant infection with HIV or hepatitis B
Participation in a clinical trial within 30 days prior to study start
Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

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
Peginterferon alfa-2aAlso: PegasysPeginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.	Drug	Peginterferon alfa-2a + Ribavirin
RibavirinAlso: CopegusRibavirin according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.	Drug	Peginterferon alfa-2a + Ribavirin

Primary outcome

Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
Time frame: 6 months after the last study drug administration (up to 123.6 weeks)
SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

6 secondary outcomes

Percentage of Participants With Undetectable HCV RNA
Time frame: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)
HCV RNA Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Thrombocyte Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Leukocyte Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hemoglobin Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
Time frame: Up to 99.6 Weeks

Results and safety

Results posted to the registry on 15 Feb 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
Peginterferon Alfa-2a + Ribavirin	270	217

Primary outcome: Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment

Time frame: 6 months after the last study drug administration (up to 123.6 weeks). Number. Unit: percentage of participants

Measure	Peginterferon Alfa-2a + Ribavirin n = 268
All participants (n=268)	66
G1 (n=104)	51
G2 (n=9)	67
G3 (n=153)	75
G4 (n=2)	100
CC (n=56)	66
CT (n=73)	66
TT (n=25)	64

Population analysed: All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signature of informed consent to end of treatment (up to 99.6 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginterferon Alfa-2a + Ribavirin	4 of 268 (1.5%)	15 of 268 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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

4 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 4 sites in Slovenia.

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 3 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Slovenia. 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 15 Feb 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?

Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment (time frame: 6 months after the last study drug administration (up to 123.6 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 NCT02556307.

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 15 Feb 2016.