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Hepatitis C, ChronicPhase 4NCT00192647

A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

A Phase 4 study testing PEG-IFN alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 51 sites in 6 countries.

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 addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
PEG-IFN alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
896 participants
Where
51 sitesin 6 countries
Study dates
Aug 2004to Mar 2009
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of chronic CHC, genotype 1
  • Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
  • Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
  • Compensated liver disease
  • Naive to interferon-based therapy for CHC infection

Who cannot join

  • Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
  • Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
  • Chronic liver disease other than CHC infection

Trial locations and contacts

51 sites in 6 countries.

51 sites in 6 countries

Australia33 sites

  • Study site

    Adelaide, 5000

  • Study site

    Adelaide, 5042

  • Study site

    Bankstown, 2200

  • Study site

    Box Hill, 3128

  • Study site

    Brisbane, 4029

  • Study site

    Cottontree, 4558

  • Study site

    Darlinghurst, 2010

  • Study site

    Douglas

  • Study site

    Fitzroy, 3065

  • Study site

    Fremantle, 6160

  • Study site

    Geelong, 3220

  • Study site

    Greenslopes, 4120

  • Study site

    Kingswood

  • Study site

    Lismore, 2480

  • Study site

    Liverpool, 1871

  • Study site

    Liverpool, 2170

  • Study site

    Melbourne, 3011

  • Study site

    Melbourne, 3084

  • Study site

    Melbourne, 3181

  • Study site

    Melbourne, 3186

  • Study site

    Miranda, 2228

  • Study site

    Nedlands, 6009

  • Study site

    New Lambton Heights, 2310

  • Study site

    Parkville, 3052

  • Study site

    Perth, 6001

  • Study site

    Sydney, 2010

  • Study site

    Sydney, 2050

  • Study site

    Sydney, 2139

  • Study site

    Sydney, 2145

  • Study site

    Victoria, 3199

  • Study site

    Woden, 2606

  • Study site

    Wollongong, 2500

  • Study site

    Woolloongabba, 4102

Other trials in Australia

Canada5 sites

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Edmonton, Alberta, T5H 4B9

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Argentina4 sites

  • Study site

    Buenos Aires, 1640

  • Study site

    Buenos Aires, C1282AFE

  • Study site

    La Plata, B1902AVF

  • Study site

    Rosario, 2000

Other trials in Argentina

Mexico3 sites

  • Study site

    Guadalajara, 44280

  • Study site

    Guadalajara, 44650

  • Study site

    Monterrey, 64460

Other trials in Mexico

New Zealand3 sites

  • Study site

    Auckland, 100

  • Study site

    Hamilton

  • Study site

    Riccarton, Christchurch, 8011

Other trials in New Zealand

Thailand3 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50202

Other trials in Thailand

About this study

Official title: A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Being tested
PEG-IFN 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.

  • PEG-IFN alfa-2aDrug

    Also called Pegasys

    PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.

  • RibavirinDrug

    Also called Copegus

    Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.

Study groups in NCT00192647
Study groupRoleWhat they receive
PEG-IFN alfa-2a+Ribavirin - Induction TreatmentExperimentalParticipants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
Receives: Drug: PEG-IFN alfa-2a; Drug: Ribavirin
PEG-IFN alfa-2a+Ribavirin - Standard TreatmentExperimentalParticipants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
Receives: Drug: PEG-IFN alfa-2a; Drug: Ribavirin

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 According to Scheduled Treatment Period

    Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.

    Measured: Week 72

Secondary outcomes (5)

  1. Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period

    Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.

    Measured: Weeks 48

  2. Percentage of Participants With Virological Responses Over Time

    Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.

    Measured: Weeks 4, 8, 12, and 24

  3. Percentage of Participants With Relapse of End-of-treatment Virological Response

    Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.

    Measured: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)

  4. Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response

    The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.

    Measured: Weeks 4, 12, and 72

  5. Change From Baseline in Log10 HCV RNA Values

    The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.

    Measured: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)

Timeline

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

  1. First posted19 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
896 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00192647
Sponsor's protocol ID
ML17908
Status last verified
Jun 2016
First submitted
13 Sep 2005
Last updated
4 Aug 2016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEG-IFN alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 51 sites in 6 countries.

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

Where is the study taking place?

The record lists 51 sites in Australia, Canada, Argentina, Mexico, New Zealand and 1 more country. 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 14 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 According to Scheduled Treatment Period (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 NCT00192647.

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 4 Aug 2016.

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