NCT01337375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

March 29, 2011

Last Update Submit

November 1, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Evaluation of predictors of response to i.v. treatment

    11 months

  • Effect of waist to hip ratio on pharmacokinetics

    11 months

  • Effect of waist to hip ratio on viral response

    11 months

  • Incidence of adverse events

    11 months

Study Arms (2)

A/B

EXPERIMENTAL
Drug: peginterferon alfa 2a [Pegasys]Drug: peginterferon alfa-2a [Pegasys]

C/D

EXPERIMENTAL
Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa 2a [Pegasys]DRUG

sc weekly

A/B
peginterferon alfa-2a [Pegasys]DRUG

iv weekly

A/B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Berlin, 10969, Germany

Location

Unknown Facility

Frankfurt am Main, 60590, Germany

Location

Unknown Facility

Hamburg, 20099, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 18, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(5)