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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

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ClinicalTrials.gov Identifier: NCT01337375
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: peginterferon alfa 2a [Pegasys] Drug: peginterferon alfa-2a [Pegasys] Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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Arm Intervention/treatment
Experimental: A/B Drug: peginterferon alfa 2a [Pegasys]
sc weekly

Drug: peginterferon alfa-2a [Pegasys]
iv weekly

Experimental: C/D Drug: peginterferon alfa-2a [Pegasys]
sc twice weekly

Drug: peginterferon alfa-2a [Pegasys]
iv twice weekly




Primary Outcome Measures :
  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 [ Time Frame: 11 months ]

Secondary Outcome Measures :
  1. Evaluation of predictors of response to i.v. treatment [ Time Frame: 11 months ]
  2. Effect of waist to hip ratio on pharmacokinetics [ Time Frame: 11 months ]
  3. Effect of waist to hip ratio on viral response [ Time Frame: 11 months ]
  4. Incidence of adverse events [ Time Frame: 11 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337375


Locations
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Germany
Berlin, Germany, 10969
Frankfurt Am Main, Germany, 60590
Hamburg, Germany, 20099
Hannover, Germany, 30625
Leipzig, Germany, 04103
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01337375    
Other Study ID Numbers: ML22936
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs