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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)

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ClinicalTrials.gov Identifier: NCT01585324
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin [Copegus] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, Multicenter Phase IV Study, Evaluating Drop of Hemoglobin in Association to the Rate of Sustained Virological Response in Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO)
Study Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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Arm Intervention/treatment
Experimental: Single Arm Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly

Drug: ribavirin [Copegus]
1000 mg or 1200 mg orally daily




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment [ Time Frame: 24 weeks after the end of treatment (72 weeks) ]
    SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

  2. Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR [ Time Frame: Baseline and Week 12 ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Decrease in Hemoglobin [ Time Frame: Week 12 ]
    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.

  2. Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR [ Time Frame: Week 12 ]
    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.

  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585324


Locations
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Czech Republic
Most, Czech Republic, 43401
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01585324     History of Changes
Other Study ID Numbers: ML25186
2011-001256-10 ( EudraCT Number )
First Posted: April 25, 2012    Key Record Dates
Results First Posted: July 24, 2015
Last Update Posted: July 24, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs