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Hepatitis C, ChronicPhase 4NCT01447420

A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

A Phase 4 study testing peginterferon alfa-2a and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 15 sites in Brazil.

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 multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
peginterferon alfa-2a and ribavirin [Copegus]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
15 sitesBrazil
Study dates
Feb 2011to Nov 2012
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 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >/=18 and <70 years of age at initiation of treatment
  • Body weight between 50 kg and 125 kg at baseline
  • Chronic hepatitis C, genotype 1
  • Chronic liver disease consistent with HCV infection
  • Compensated liver disease (Child-Pugh Grade A)

Who cannot join

  • Pregnant or lactating women, and male partners of pregnant women
  • Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
  • Previous treatment with interferon or ribavirin
  • Positive for hepatitis A, hepatitis B or HIV infection
  • History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
  • Decompensated liver disease and/or liver disease Child-Pugh classification >6
Show all 10Show fewer
  • Hepatocellular carcinoma
  • History or evidence of esophageal bleeding
  • Hemoglobinopathy, or any other cause for possible hemolysis
  • Hb <11 g/dL in women, <12 g/L in males

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Brazil15 sites

  • Study site

    Botucatu, São Paulo, 18600-400

  • Study site

    Campinas, São Paulo, 13026-210

  • Study site

    Campinas, São Paulo, 13060-803

  • Study site

    Joinville, Santa Catarina, 89202-050

  • Study site

    Juiz de Fora, Minas Gerais, 36038-330

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20020-022

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20270-004

  • Study site

    Salvador, Estado de Bahia, 41110-170

  • Study site

    Santos, São Paulo, 11015470

  • Study site

    Sao Jose Do Rio Preto, Santa Catarina, 15090-000

  • Study site

    São Paulo, São Paulo, 04040-003

  • Study site

    São Paulo, São Paulo, 04119-001

  • Study site

    São Paulo, São Paulo, 04266-010

  • Study site

    Sorocaba, São Paulo, 18047-600

  • Study site

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

About this study

Official title: A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Being tested
peginterferon alfa-2a, 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-2aDrug

    180 mcg sc weekly, 48 weeks

  • ribavirin [Copegus]Drug

    1'000 or 1'200 mg orally daily, 48 weeks

Study groups in NCT01447420
Study groupRoleWhat they receive
Peginterferon Alfa-2a Plus RibavirinExperimentalNot described
Receives: Drug: peginterferon alfa-2a; Drug: ribavirin [Copegus]

What is being measured

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

  1. Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression

    Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.

    Measured: At Week 72

  2. Percentage of Participants With Incidence of Anemia

    Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.

    Measured: Up to Week 72

Secondary outcomes (3)

  1. Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression

    Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.

    Measured: Weeks 4, 12, 24, 48, 60 and 72

  2. Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment

    Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.

    Measured: Up to Week 72

  3. Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12

    Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.

    Measured: From Baseline (Week 0) to Week 12

Timeline

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

  1. First posted6 Oct 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01447420
Sponsor's protocol ID
ML25592
Status last verified
Jun 2016
First submitted
4 Oct 2011
Last updated
25 Jul 2016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing peginterferon alfa-2a and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 15 sites in Brazil.

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 10 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Brazil. 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 Jun 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 Sustained Virological Response Rate in Relation to Interleukin 28B Expression (time frame: At Week 72). 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 NCT01447420.

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 25 Jul 2016.

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