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TerminatedNCT02791256Updated Jun 8, 2016

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 interventional study of Ribavirin and peginterferon alfa-2a in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Terminated at 21 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-08.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).

02

Conditions studied

  • Hepatitis C, Chronic
03

In context

Hepatitis C, Chronic

1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 23 is below the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Peginterferon Alfa-2a + Ribavirin

    Participants 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.

    Drug: Ribavirin · Drug: peginterferon alfa-2a

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 56

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

    Time frame: 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

    Time frame: Baseline, Week 2, 4, 8, 12, 32, 56

  4. Number of Participants With Adverse Events and Serious Adverse

    Time frame: Baseline up to Week 56

07

Study locations

21 sites
  • Antwerp, 2018, Belgium
  • Antwerp, 2060, Belgium
  • Bruges, 8000, Belgium
  • Brussels, 1000, Belgium
  • Brussels, 1020, Belgium
  • Brussels, 1070, Belgium
  • Brussels, 1090, Belgium
  • Brussels, 1180, Belgium
  • Brussels, 1190, Belgium
  • Brussels, 1200, Belgium
  • Charleroi, 6000, Belgium
  • Edegem, 2650, Belgium
  • Ghent, 9000, Belgium
  • Gilly, 6060, Belgium
  • Haine-Saint-Paul, 7100, Belgium
  • Kortrijk, 8500, Belgium
  • Leuven, 3000, Belgium
  • Liège, 4000, Belgium
  • Namur, 5000, Belgium
  • Roeselare, 8800, Belgium
  • Yvoir, 5530, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2016
First posted
Jun 6, 2016
Start
Jun 2005
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Last update
Jun 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02791256
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jun 6, 2016
Start date
Jun 2005
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jun 8, 2016

Study contacts

Clinical Trials
study chair · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ribavirin · Peginterferon alfa-2a

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