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)

Hepatitis C, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585324
• Other study ID #: ML25186
• Secondary ID: 2011-001256-10
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2012
• Last updated: June 25, 2015
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly
• ribavirin [Copegus]
1000 mg or 1200 mg orally daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks after the end of treatment (72 weeks)	No
Primary	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.	Baseline and Week 12	No
Secondary	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.	Week 12	No
Secondary	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.	Week 12	No
Secondary	Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR		Week 12	No
Secondary	Number of Participants With Neutropenia Among Participants With or Without SVR		Week 12	No
Secondary	Number of Participants With Thrombocytopenia Among Participants With or Without SVR		Week 12	No