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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01344889
Other study ID # MV22255
Secondary ID
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


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
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