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NCT Number: NCT01585324

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)

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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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Most, 43401, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 mcg subcutaneously weekly

ribavirin [Copegus]

Drug

1000 mg or 1200 mg orally daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2012
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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