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Hepatitis C, ChronicPhase 3NCT02791256

A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6

A Phase 3 study testing Ribavirin and peginterferon alfa-2a in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 21 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a 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?
Ribavirin and peginterferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
21 sitesBelgium
Study dates
Jun 2005to Jun 2008
Phase
Phase 3
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

  • Participants with serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
  • Participants had to have been receiving their first treatment for chronic hepatitis C (i.e. previously naive to any therapy) consisting of peginterferon alfa-2a plus ribavirin for 16 weeks (+/- 10 days), without reaching a negative or 2-log drop of Serum Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at Week 12 of therapy as compared to pretreatment value, and must still be on therapy (no wash out)
  • HCV-RNA quantifiable by a test reporting in international units
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • Participants with cirrhosis or transition to cirrhosis had to have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma and a serum alpha fetoprotein (AFP) less than (<)100 nanogram pe milliliter (ng/mL) within 6 months of study entry
  • Negative urine or blood pregnancy test
  • Participants had to be using two forms of effective contraception during treatment and during the 6 months after treatment end
  • Able to participate and to comply with the study restrictions

Who cannot join

  • Women with ongoing pregnancy or who are breast feeding and male partners of women who were pregnant
  • Neutrophil count <1,500 cells/cubic millimeter (mm^3) or platelet count <90,000 cells/mm^3 before initiation of the ongoing treatment regimen; or neutrophil count <750 cells/mm^3 or platelet count <50,000 cells/mm^3 at screening while still on therapy with peginterferon alfa-2a plus ribavirin
  • Hemoglobin (Hgb) <12 gram per deciliter (g/dL) before initiation of the ongoing treatment regimen; or Hgb <10 g/dL at screening while still on therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
  • Serum creatinine level greater than (>)1.5 times the upper limit of normal at screening
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) other than the currently failing Pegasys plus ribavirin combination therapy less than or equal to (<=) 6 months prior to the first dose of study drug
  • Positive test for hepatitis A immunoglobulin M (IgM) antibody (anti-HAV IgM Ab), hepatitis B surface antigen (HBsAg), anti-hepatitis B core IgM antibody (anti-HBc IgM Ab), anti-Human Immunodeficiency Virus antibody (anti-HIV Ab)
Show all 9Show fewer
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV
  • History of bleeding from esophageal varices or other conditions consistent with decompensated liver disease, severe psychiatric disease (especially depression), severe seizure disorder, thyroid disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, major organ transplantation or other evidence of severe illness, malignancy
  • Evidence of drug abuse including excessive alcohol consumption

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Belgium21 sites

  • Study site

    Antwerp, 2018

  • Study site

    Antwerp, 2060

  • Study site

    Bruges, 8000

  • Study site

    Brussels, 1000

  • Study site

    Brussels, 1020

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1180

  • Study site

    Brussels, 1190

  • Study site

    Brussels, 1200

  • Study site

    Charleroi, 6000

  • Study site

    Edegem, 2650

  • Study site

    Ghent, 9000

  • Study site

    Gilly, 6060

  • Study site

    Haine-Saint-Paul, 7100

  • Study site

    Kortrijk, 8500

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

  • Study site

    Namur, 5000

  • Study site

    Roeselare, 8800

  • Study site

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: An Open-label Pilot Study of Dose Escalation of PEGASYS on Virological Response in Patients With Chronic Hepatitis C Viral Infection Showing an Early Non-response to a Standard Course of PEGASYS Plus Ribavirin

This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).

Being tested
Ribavirin, peginterferon alfa-2a
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.

  • RibavirinDrug

    Also called Copegus, Ro 20-9963

  • peginterferon alfa-2aDrug

    Also called Pegasys, Ro 25-8310

Study groups in NCT02791256
Study groupRoleWhat they receive
Peginterferon Alfa-2a + RibavirinExperimentalParticipants will receive 360 microgram (mcg) of Peginterferon Alfa-2a subcutaneous (SC) once a week plus ribavirin (1000 - 1200 milligram per day [mg/day] orally as a split dose in the morning and the evening based on the participant's body weight) for 32 weeks.
Receives: Drug: Ribavirin; Drug: peginterferon alfa-2a

What is being measured

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

  1. Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test

    Measured: Week 12

Secondary outcomes (4)

  1. Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test

    Measured: Week 56

  2. Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test

    Measured: Week 32

  3. Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load

    Measured: Baseline, Week 2, 4, 8, 12, 32, 56

  4. Number of Participants With Adverse Events and Serious Adverse

    Measured: Baseline up to Week 56

Timeline

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

  1. First posted6 Jun 2016 (estimated)
  2. Study startJun 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02791256
Sponsor's protocol ID
ML18232
Other IDs
2005-000198-22, 2005
Status last verified
Jun 2016
First submitted
31 May 2016
Last updated
8 Jun 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribavirin and peginterferon alfa-2a in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 21 sites in Belgium.

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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early. Results are not available in the source record.

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 Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test (time frame: Week 12). 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 NCT02791256.

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 8 Jun 2016.

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