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
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Albania: Ministry of Health |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
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,
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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