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Hepatitis C, ChronicPhase 4NCT00412334

SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.

A Phase 4 study testing Copegus and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 22 sites in France.

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

This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Copegus and peginterferon alfa-2a [Pegasys]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
22 sitesFrance
Study dates
Jan 2007to Sep 2010
Phase
Phase 4
Are there results?
None posted in the registry

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, with CHC genotype 1;
  • patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for >=12 weeks;
  • patients who have discontinued PEGASYS/ribavirin >=4 weeks prior to enrollment;
  • compensated liver disease.

Who cannot join

  • other forms of liver disease;
  • infection with HIV, HAV, HBV;
  • hepatocellular cancer.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • Study site

    Angers, 49033

  • Study site

    Bobigny, 93009

  • Study site

    Châteauroux, 36019

  • Study site

    Créteil, 94000

  • Study site

    Créteil, 94010

  • Study site

    Grenoble, 38043

  • Study site

    Hyères, 83407

  • Study site

    Lille, 59037

  • Study site

    Limoges, 87042

  • Study site

    Marseille, 13285

  • Study site

    Marseille, 13385

  • Study site

    Metz, 57038

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06202

  • Study site

    Paris, 75651

  • Study site

    Paris, 75679

  • Study site

    Pessac, 33604

  • Study site

    Poitiers, 86021

  • Study site

    Strasbourg, 67091

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Villejuif, 94804

Other trials in France

About this study

Official title: Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy

This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Being tested
Copegus, peginterferon alfa-2a [Pegasys]
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.

  • CopegusDrug

    1200-1600mg/day po

  • CopegusDrug

    1000-1200mg/day po

  • peginterferon alfa-2a [Pegasys]Drug

    360 micrograms sc weekly

  • peginterferon alfa-2a [Pegasys]Drug

    180 micrograms sc twice weekly

Study groups in NCT00412334
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys]
2ExperimentalNot described
Receives: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys]
3ExperimentalNot described
Receives: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys]
4ExperimentalNot described
Receives: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys]

What is being measured

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

  1. Sustained viral response

    Measured: Week 72

Secondary outcomes (3)

  1. Percentage of patients with >=2log drop of HCV-RNA

    Measured: Week 4, 12, 24.

  2. Percentage of patients with non-detectable HCV-RNA

    Measured: Week 48

  3. Relapse rate

    Measured: Throughout study.

Timeline

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

  1. First posted18 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00412334
Sponsor's protocol ID
ML20399
Status last verified
Apr 2016
First submitted
15 Dec 2006
Last updated
5 Apr 2016
Results posted
No

Publications

  • Chevaliez S, Hezode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.

    PubMed 21439960

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Copegus and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 22 sites in France.

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 4 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 viral response (time frame: 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 NCT00412334, 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 5 Apr 2016.

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