Hepatitis C, ChronicPhase 4NCT01585324

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 1 site in Czechia.

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 [Pegasys] and ribavirin [Copegus]
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteCzechia
Study dates: Jan 2012to Jan 2014
Phase: Phase 4
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

Who may be able to join

Adult patients, >/= 18 years of age
Chronic hepatitis C, genotype 1
Treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
Detectable HCV-RNA
Fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end

Who cannot join

Pregnant or breast-feeding women
Male partners of pregnant women
History or evidence of a medical condition associated with chronic liver disease other than HCV
Co-infection with active hepatitis A, hepatitis B and/or HIV virus
Hepatocellular carcinoma
History or evidence of oesophageal varices or other conditions consistent with decompensated liver disease

Show all 13Show fewer

Anemia
Any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis, history of GI bleeding)
History or evidence of significant cardiovascular disease
Kidney disease
Severe retinopathy
History of severe psychiatric disease, especially depression
Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) </= 6 months prior to first dose of study drug

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Study site
Most, 43401

Other trials in Czechia

About this study

Official title: Open, Multicenter Phase IV Study, Evaluating Drop of Hemoglobin in Association to the Rate of Sustained Virological Response in Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO)

This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

Conditions: Hepatitis C, Chronic
Being tested: peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
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-2a [Pegasys]Drug
180 mcg subcutaneously weekly
ribavirin [Copegus]Drug
1000 mg or 1200 mg orally daily

Study groups in NCT01585324
Study group	Role	What they receive
Single Arm	Experimental	Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

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) 24 Weeks After End of Treatment
SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Measured: 24 weeks after the end of treatment (72 weeks)
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.
Measured: Baseline and Week 12

Secondary outcomes (5)

Number of Participants With Decrease in Hemoglobin
The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.
Measured: Week 12
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.
Measured: Week 12
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Measured: Week 12
Number of Participants With Neutropenia Among Participants With or Without SVR
Measured: Week 12
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
Measured: Week 12

Timeline

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

Jan 2012Jan 2014

First posted25 Apr 2012 (estimated)
Study startJan 2012
Primary completionJan 2014
Study completionJan 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01585324
Sponsor's protocol ID: ML25186
Other IDs: 2011-001256-10
Status last verified: Jun 2015
First submitted: 24 Apr 2012
Last updated: 24 Jul 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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b
Active, not recruitingPhase 4
Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels
Hepatitis B, Chronic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Multicenter Phase IV Study, Evaluating Drop of Hemoglobin in Association to the Rate of Sustained Virological Response in Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO)
ClinicalTrials.gov ID: NCT01585324
Acronym / sponsor ID: ML25186
Conditions: Hepatitis C, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 25 Apr 2012 (estimated)
Results: Posted 24 Jul 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

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus]

Who may qualify

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

Key inclusion criteria (5 listed)

Adult patients, >/= 18 years of age
Chronic hepatitis C, genotype 1
Treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
Detectable HCV-RNA
Fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end

Key exclusion criteria (13 listed)

Pregnant or breast-feeding women
Male partners of pregnant women
History or evidence of a medical condition associated with chronic liver disease other than HCV
Co-infection with active hepatitis A, hepatitis B and/or HIV virus
Hepatocellular carcinoma

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-2a [Pegasys]180 mcg subcutaneously weekly	Drug	Single Arm
ribavirin [Copegus]1000 mg or 1200 mg orally daily	Drug	Single Arm

Primary outcome

Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
Time frame: 24 weeks after the end of treatment (72 weeks)
SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
Time frame: Baseline and Week 12
Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

5 secondary outcomes

Number of Participants With Decrease in Hemoglobin
Time frame: Week 12
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
Time frame: Week 12
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Time frame: Week 12
Number of Participants With Neutropenia Among Participants With or Without SVR
Time frame: Week 12
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
Time frame: Week 12

Results and safety

Results posted to the registry on 24 Jul 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
Peginterferon Alpha-2a + Ribavirin	30	30

Primary outcome: Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment

Time frame: 24 weeks after the end of treatment (72 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Peginterferon Alpha-2a + Ribavirin n = 30
Value	83.3 (65.28 to 94.36)

Peginterferon Alpha-2a + Ribavirin: p = 0.8333, ANCOVA

Population analysed: ITT population included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: grams per liter (g/L)

Measure	Participants With SVR n = 25	Participants Without SVR n = 5
Value	-23.0 (14.768)	-32.4 (11.502)

Population analysed: ITT population included all enrolled participants who received at least 1 dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 24 weeks after end of treatment (up to 72 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginterferon Alpha-2a + Ribavirin	0 of 30 (0%)	19 of 30 (63.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b
Active, not recruitingPhase 4
Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels
Hepatitis B, Chronic

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?

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 1 site in Czechia.

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 13 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 24 Jul 2015. 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 Czechia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 24 Jul 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) 24 Weeks After End of Treatment (time frame: 24 weeks after the end of treatment (72 weeks)). The study lists 2 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 NCT01585324.

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 24 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.