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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344889
• Other study ID #: MV22255
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: November 1, 2016
• Start date: October 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Albania: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4459
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Albania,  Algeria,  Bahrain,  Belgium,  Bosnia and Herzegovina,  Brazil,  Egypt,  Greece,  Hungary,  India,  Iran, Islamic Republic of,  Italy,  Korea, Republic of,  Kuwait,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Morocco,  Pakistan,  Poland,  Portugal,  Qatar,  Romania,  Serbia,  Slovakia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin		4 years	No
Primary	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)		4 years	No
Secondary	Correlation of on-treatment factors and dose reduction/treatment discontinuation		4 years	No
Secondary	Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR		4 years	No
Secondary	Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients		4 years	No
Secondary	Safety: Incidence of adverse events		4 years	No