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NCT Number: NCT01344889

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Elbasan, Albania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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