Chronic Hepatitis CNCT02106156

Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

An observational study of Chronic Hepatitis C, run by Hoffmann-La Roche at 1 site in Germany.

Completed

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

Trial summary

This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C
What is being tested?: Pegylated interferon alfa-2a and Ribavirin
How many people: 10,228 participants
Where: 1 siteGermany
Study dates: Jan 2008to Sep 2013
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 CHC treated with peginterferon alfa-2a and ribavirin according to routine clinical practice

Who may be able to join

18 years of age or over
Clinically diagnosed CHC with detectable virus replication
Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.

Who cannot join

Any contraindications for peginterferon alfa-2a or ribavirin treatment
Pregnant or breast-feeding

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Herne, 44623

Other trials in Germany

About this study

Official title: Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastroenterologists), Part III

Conditions: Chronic Hepatitis C
Being tested: Pegylated interferon 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.

Pegylated interferon alfa-2aDrug
Also called Pegasys®
Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).
RibavirinDrug
Also called Copegus®
Ribavirin administered according to corresponding summary of product characteristics (SmPC).

Study groups in NCT02106156
Study group	Role	What they receive
Chronic Hepatitis C		Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study. Receives: Drug: Pegylated interferon alfa-2a; Drug: Ribavirin

What is being measured

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

Percentage of Participants With Rapid Virologic Response (RVR)
RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Measured: At Week 4
Percentage of Participants With Early Virologic Response (EVR)
EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.
Measured: At Week 12
Percentage of Participants With End of Treatment (EOT) Response
EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.
Measured: Up to Week 72
Percentage of Participants With Sustained Virologic Response (SVR)
SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.
Measured: Up to Week 96
Percentage of Participants With Serious Adverse Drug Reactions (SADR)
Measured: Up to Week 96

Secondary outcomes (4)

Percentage Cumulative Dose of Peginterferon Alfa-2a Received
Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Measured: Up to Week 96
Percentage Cumulative Dose of Ribavirin Received
Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Measured: Up to Week 96
Duration of Peginterferon Alfa-2a Therapy
Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.
Measured: Up to Week 72
Percentage of Participants With the Most Frequent Concomitant Medications
Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.
Measured: At Baseline (Day 1)

Timeline

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

Jan 2008Sep 2013

First posted8 Apr 2014 (estimated)
Study startJan 2008
Primary completionSep 2013
Study completionSep 2013

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 Chronic Hepatitis CStudies 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: 10,228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02106156
Sponsor's protocol ID: ML21645
Status last verified: Aug 2016
First submitted: 3 Apr 2014
Last updated: 23 Sep 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Niederau C, Mauss S, Schober A, Stoehr A, Zimmermann T, Waizmann M, Moog G, Pape S, Weber B, Isernhagen K, Sandow P, Bokemeyer B, Alshuth U, Steffens H, Huppe D. Predictive factors for sustained virological response after treatment with pegylated interferon alpha-2a and ribavirin in patients infected with HCV genotypes 2 and 3. PLoS One. 2014 Sep 19;9(9):e107592. doi: 10.1371/journal.pone.0107592. eCollection 2014.
PubMed 25238535

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 Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastroenterologists), Part III
ClinicalTrials.gov ID: NCT02106156
Acronym / sponsor ID: ML21645
Conditions: Chronic Hepatitis C
Study type: Observational
Recruitment status: Completed
Enrolment: 10,228 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 23 Sep 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
Chronic Hepatitis C	–	Drug: Pegylated interferon alfa-2a, Drug: RibavirinParticipants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with CHC treated with peginterferon alfa-2a and ribavirin according to routine clinical practice

Key inclusion criteria (3 listed)

18 years of age or over
Clinically diagnosed CHC with detectable virus replication
Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.

Key exclusion criteria (2 listed)

Any contraindications for peginterferon alfa-2a or ribavirin treatment
Pregnant or breast-feeding

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
Pegylated interferon alfa-2aAlso: Pegasys®Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).	Drug	Chronic Hepatitis C
RibavirinAlso: Copegus®Ribavirin administered according to corresponding summary of product characteristics (SmPC).	Drug	Chronic Hepatitis C

Primary outcome

Percentage of Participants With Rapid Virologic Response (RVR)
Time frame: At Week 4
RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Percentage of Participants With Early Virologic Response (EVR)
Time frame: At Week 12
EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.
Percentage of Participants With End of Treatment (EOT) Response
Time frame: Up to Week 72
EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.
Percentage of Participants With Sustained Virologic Response (SVR)
Time frame: Up to Week 96
SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.
Percentage of Participants With Serious Adverse Drug Reactions (SADR)
Time frame: Up to Week 96

4 secondary outcomes

Percentage Cumulative Dose of Peginterferon Alfa-2a Received
Time frame: Up to Week 96
Percentage Cumulative Dose of Ribavirin Received
Time frame: Up to Week 96
Duration of Peginterferon Alfa-2a Therapy
Time frame: Up to Week 72
Percentage of Participants With the Most Frequent Concomitant Medications
Time frame: At Baseline (Day 1)

Results and safety

Results posted to the registry on 23 Sep 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
Main Analysis Set	9,620	7,071
Elastography Analysis Set: Treated	90	50
Elastography Analysis Set: Untreated	518	518

Primary outcome: Percentage of Participants With Rapid Virologic Response (RVR)

Time frame: At Week 4. Number. Unit: percentage of participants

Measure	Main Analysis Set n = 6442	Elastography Analysis Set: Treated n = 60
Value	40.0	41.7

Population analysed: Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.

Primary outcome: Percentage of Participants With Early Virologic Response (EVR)

Time frame: At Week 12. Number. Unit: percentage of participants

Measure	Main Analysis Set n = 7383	Elastography Analysis Set: Treated n = 54
Value	71.2	77.8

Primary outcome: Percentage of Participants With End of Treatment (EOT) Response

Time frame: Up to Week 72. Number. Unit: percentage of participants

Measure	Main Analysis Set n = 9620	Elastography Analysis Set: Treated n = 90
Value	59.2	51.1

Population analysed: Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.

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

Time frame: Up to Week 96. Number. Unit: percentage of participants

Measure	Main Analysis Set n = 9620	Elastography Analysis Set: Treated n = 90
Value	41.4	36.7

Population analysed: Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 96. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Analysis Set	439 of 9,620 (4.6%)	5,721 of 9,620 (59.5%)	Not reported
Elastography Analysis Set: Treated	4 of 90 (4.4%)	82 of 90 (91.1%)	Not reported
Elastography Analysis Set: Untreated	0 of 518 (0%)	0 of 518 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25238535Niederau C, Mauss S, Schober A, Stoehr A, Zimmermann T, Waizmann M, Moog G, Pape S, Weber B, Isernhagen K, Sandow P, Bokemeyer B, Alshuth U, Steffens H, Huppe D. Predictive factors for sustained virological response after treatment with pegylated interferon alpha-2a and ribavirin in patients infected with HCV genotypes 2 and 3. PLoS One. 2014 Sep 19;9(9):e107592. doi: 10.1371/journal.pone.0107592. eCollection 2014.

Related trials for Chronic Hepatitis C

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C, run by Hoffmann-La Roche at 1 site in Germany.

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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 23 Sep 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 With Rapid Virologic Response (RVR) (time frame: At Week 4). The study lists 5 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 NCT02106156, 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 23 Sep 2016.