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An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344889
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

Condition or disease
Hepatitis C, Chronic

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Study Type : Observational
Actual Enrollment : 4459 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected With Chronic Hepatitis C Receiving a Long Acting Interferon Plus Ribavirin
Study Start Date : October 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin [ Time Frame: 4 years ]
  2. Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Correlation of on-treatment factors and dose reduction/treatment discontinuation [ Time Frame: 4 years ]
  2. Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR [ Time Frame: 4 years ]
  3. Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients [ Time Frame: 4 years ]
  4. Safety: Incidence of adverse events [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis C receiving a long-acting interferon plus ribavirin

Inclusion Criteria:

  • Adult patients (according to local legislation)
  • Chronic hepatitis C
  • Treatment with long-acting interferon plus ribavirin
  • Quantifiable HCV RNA before initiation of treatment
  • No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label

Exclusion Criteria:

  • End stage renal disease
  • Major organ transplantation
  • Concomitant therapy with telbivudine
  • Pregnant or breast-feeding females
  • Male partners of pregnant females

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 identifier (NCT number): NCT01344889

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Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT01344889    
Other Study ID Numbers: MV22255
First Posted: April 29, 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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic