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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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

peginterferon alfa 2a [Pegasys]

peginterferon alfa-2a [Pegasys]

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A/B

C/D

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of predictors of response to i.v. treatment

Effect of waist to hip ratio on pharmacokinetics

Effect of waist to hip ratio on viral response

Incidence of adverse events

Full Information

NCT ID

NCT01337375

First Posted

March 29, 2011

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01337375

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A/B

Arm Type

Experimental

Arm Title

C/D

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa 2a [Pegasys]

Intervention Description

sc weekly

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

iv weekly

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

sc twice weekly

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

iv twice weekly

Primary Outcome Measure Information:

Title

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

Time Frame

11 months

Secondary Outcome Measure Information:

Title

Evaluation of predictors of response to i.v. treatment

Time Frame

11 months

Title

Effect of waist to hip ratio on pharmacokinetics

Time Frame

11 months

Title

Effect of waist to hip ratio on viral response

Time Frame

11 months

Title

Incidence of adverse events

Time Frame

11 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Berlin

ZIP/Postal Code

10969

Country

Germany

City

Frankfurt Am Main

ZIP/Postal Code

60590

Country

Germany

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

City

Hannover

ZIP/Postal Code

30625

Country

Germany

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

12. IPD Sharing Statement

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