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CompletedNCT01585324Updated Jul 24, 2015Results posted

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

A Phase 4 interventional study of peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-24.

Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

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Conditions studied

  • Hepatitis C, Chronic
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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

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

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Who can participate

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C, genotype 1
  • Treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
  • Detectable HCV-RNA
  • Fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Male partners of pregnant women
  • History or evidence of a medical condition associated with chronic liver disease other than HCV
  • Co-infection with active hepatitis A, hepatitis B and/or HIV virus
  • Hepatocellular carcinoma
  • History or evidence of oesophageal varices or other conditions consistent with decompensated liver disease
  • Anemia
  • Any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis, history of GI bleeding)
  • History or evidence of significant cardiovascular disease
  • Kidney disease
  • Severe retinopathy
  • History of severe psychiatric disease, especially depression
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \</= 6 months prior to first dose of study drug
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Single Arm

    Drug: peginterferon alfa-2a [Pegasys] · Drug: ribavirin [Copegus]

Interventions

  • Drugpeginterferon alfa-2a [Pegasys]

    180 mcg subcutaneously weekly

  • Drugribavirin [Copegus]

    1000 mg or 1200 mg orally daily

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What researchers measure

Primary outcomes

  1. Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment

    SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

    Time frame: 24 weeks after the end of treatment (72 weeks)

  2. Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR

    Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Number of Participants With Decrease in Hemoglobin

    The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than \[\>\] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.

    Time frame: Week 12

  2. Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR

    The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

    Time frame: Week 12

  3. Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR

    Time frame: Week 12

  4. Number of Participants With Neutropenia Among Participants With or Without SVR

    Time frame: Week 12

  5. Number of Participants With Thrombocytopenia Among Participants With or Without SVR

    Time frame: Week 12

07

Results

Posted Jul 24, 2015

Participant flow

Participant flow — Overall Study
MilestonePeginterferon Alpha-2a + Ribavirin
Started30
Completed30
Not completed0

Outcome measures

PrimaryPercentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment

SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

Time frame:
24 weeks after the end of treatment (72 weeks)
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
percentage of participantsPeginterferon Alpha-2a + Ribavirin
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment83.3 (65.28 to 94.36)
Statistical analysis
  • Peginterferon Alpha-2a + Ribavirin · ANCOVA · p = 0.8333The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.
PrimaryChange From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR

Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

Time frame:
Baseline and Week 12
Reported as:
Mean · grams per liter (g/L)
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
grams per liter (g/L)Participants With SVRParticipants Without SVR
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR-23.0 ± 14.768-32.4 ± 11.502
SecondaryNumber of Participants With Decrease in Hemoglobin

The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than \[\>\] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.

Time frame:
Week 12
Reported as:
Number · participants
Number of Participants With Decrease in Hemoglobin
participantsParticipants With SVRParticipants Without SVR
Up to 20 g/L90
20-40 g/L143
>40 g/L22
Statistical analysis
  • Participants With SVR vs Participants Without SVR · Fisher Exact · p = 0.0867
SecondaryLowest Hemoglobin Level During Treatment Among Participants With or Without SVR

The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

Time frame:
Week 12
Reported as:
Mean · g/L
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
g/LParticipants With SVRParticipants Without SVR
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR124.24 ± 10.080126.60 ± 10.383
SecondaryNumber of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Time frame:
Week 12
Reported as:
Number · participants
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
participantsParticipants With SVRParticipants Without SVR
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR10
Statistical analysis
  • Participants With SVR vs Participants Without SVR · ANCOVA · p = 0.6492
SecondaryNumber of Participants With Neutropenia Among Participants With or Without SVR
Time frame:
Week 12
Reported as:
Number · participants
Number of Participants With Neutropenia Among Participants With or Without SVR
participantsParticipants With SVRParticipants Without SVR
Number of Participants With Neutropenia Among Participants With or Without SVR00
SecondaryNumber of Participants With Thrombocytopenia Among Participants With or Without SVR
Time frame:
Week 12
Reported as:
Number · participants
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
participantsParticipants With SVRParticipants Without SVR
Number of Participants With Thrombocytopenia Among Participants With or Without SVR10
Statistical analysis
  • Participants With SVR vs Participants Without SVR · Wilcoxon (Mann-Whitney) · p = 0.0333

Adverse events

Collected over From baseline up to 24 weeks after end of treatment (up to 72 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Peginterferon Alpha-2a + Ribavirin—0/30 (0%)19/30 (63.3%)
Most frequent other events
Most frequent other events
EventPeginterferon Alpha-2a + Ribavirin
Influenza like illnessGeneral disorders14/30
FatigueGeneral disorders5/30

Baseline characteristics

Intent-to-treat (ITT) analysis population included all enrolled participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Peginterferon Alpha-2a + Ribavirin
Mean32.1 ± 7.2
Sex: Female, Male
Sex: Female, Male(Participants)Peginterferon Alpha-2a + Ribavirin
Female1
Male29
08

Study locations

1 site
  • Most, 43401, Czech Republic
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01585324
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 25, 2012
Start date
Jan 2012
Primary completion
Jan 2014
Completion
Jan 2014
Results posted
Jul 24, 2015
Last update
Jul 24, 2015

Study contacts

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

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