A Post Approval Safety Study (PASS): 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 (GUARD-C)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS6725
• Study ID:
  15700
• Official title and acronym:
  A Post Approval Safety Study (PASS): 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 (GUARD-C)
• DARWIN EU® study:
  No
• Study countries:
  Albania

  Algeria

  Bahrain

  Belgium

  Bosnia and Herzegovina

  Brazil

  Egypt

  Greece

  Hungary

  India

  Iran, Islamic Republic of

  Italy

  Korea, Republic of

  Kuwait

  Lebanon

  Morocco

  North Macedonia

  Pakistan

  Poland

  Portugal

  Qatar

  Romania

  Serbia

  Slovakia

  United Arab Emirates
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

IST GmbH

Multiple centres: 301 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:09/08/2009

Study start date

Actual:14/10/2009

Data analysis start date

Actual:16/12/2013

Date of interim report, if expected

Actual:28/10/2011

Date of final study report

Planned:24/06/2014

Actual:27/06/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)