A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy

Hepatitis C, Chronic Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337375
• Other study ID #: ML22936
• Status: Completed
• Phase: Phase 1
• First received: March 29, 2011
• Last updated: November 1, 2016
• Start date: March 2011
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial Summary

In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult caucasian patients, 18 - 70 years of age

• Hepatitis C, genotype 1

• Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin

• Compensated liver disease (Child-Pugh class A) for >/= 24 months before baseline

• Positive for anti-HCV for > 6 months, with detectable serum HCV-RNA

Exclusion Criteria:

• Treatment-naïve or responder to previous therapy

• HCV infection other than genotype 1

• Positive for Hepatitis A, Hepatitis B or HIV infection at screening

• Chronic Hepatitis of other than HCV origin

• Decompensated liver disease (Child-Pugh class B or C)

• Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study

• Clinically relevant retina disorder

• Pregnant or lactating women and male partners of pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover 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]
sc weekly
• peginterferon alfa-2a [Pegasys]
iv weekly
• peginterferon alfa-2a [Pegasys]
sc twice weekly
• peginterferon alfa-2a [Pegasys]
iv twice weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration		11 months	No
Secondary	Evaluation of predictors of response to i.v. treatment		11 months	No
Secondary	Effect of waist to hip ratio on pharmacokinetics		11 months	No
Secondary	Effect of waist to hip ratio on viral response		11 months	No
Secondary	Incidence of adverse events		11 months	No